1

Apply QUEST 3+ Token

To conduct transactions for product registration, variation, licensing, renewal and other related transactions, you must register your membership and purchase your digital certificate in the form of USB token. Once you have obtained and installed your digital certificate, you will be able to conduct your transactions in QUEST 3+.

i.                     Apply Token HERE

ii.                   Read QUEST 3+ User Manual

2

Product classification

Before submission of application for a product registration, applicants may submit for product classification if unsure of the product category.

i.                     Download Product Classification Form

ii.                   Download Drug Regulation Guidance Document (DRGD)

iii.                 Download related Directive and Circular

3

Payment Mode

Three payment option available for applicants:

a.       Payment using company account (need to register company)

b.       Payment using personal credit card

c.       Cash Payment

4

Product Category: Generic (Scheduled Poison)

4.1

Patent and Data Exclusivity status

For the purpose of registration of generic products, Product Registration Holder shall provide patent declarations as below:

         i.            Product Registration Holder shall comply with all legal provisions in Malaysia;

       ii.            The government/ authority is not liable for any offence committed by the Product Registration Holder as a result of any breach of any law; and

     iii.            Product Registration Holder shall indemnify the government if any claim is made against the government as a result of any breach of any law by the applicant whether intentionally or otherwise.

Product Registration Holder shall conform to Patent Act 1983 (Act 291) and shall not market, sell, offer for sale, or store any registered product containing any patented active ingredient(s) of which the patent duration is yet to expire.

[Check Data Exclusivity List HERE]

4.2

Ensure availability of the following key documents.

This following list is not exhaustive, for details information, refer to checklist.

4.2.1

Registration dossiers in ICH CTD / ASEAN CTD format.

i.                     ICH CTD

ii.                   ASEAN CTD

Ø  Organization of the Dossier

Ø  Glossary used for the ACTD and ACTR

Ø  Part II: Quality

Ø  Part III: Nonclinical Document

Ø  Part IV: Clinical Document

Ø  ACTD Clinical Check List for Product Classification

Glossary:

ICH - The International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use

CTD - Common Technical Document

4.2.2

GMP certificate status.

Local Manufacturer - Issued by National Pharmaceutical Regulatory Agency (NPRA) as stated in Drug Regulation Guidance Document (DRGD)

Note to follow for international manufacturer:

·                     PIC/S member countries (https://picscheme.org/en/members)

·                     Non-PIC/S member countries. GMP inspection by National Pharmaceutical Regulatory Agency (NPRA) GMP Inspectors is required.

Ø  Good Manufacturing Practice/Good Distribution Practice

Ø  Guidance Document Foreign GMP Inspection March 2018

Ø  Dokumen Panduan Keperluan Direktif Bilangan 2 Tahun 2014 dan Bilangan 2 Tahun 2015

4.2.3

CPP Certificate in WHO format (For imported product only).

A Certificate of Pharmaceutical Product which follows the format recommended by WHO shall be issued to locally manufactured products that are to be exported. For application of CPP, applicant shall fill in form BPFK 412.2: Permohonan Perakuan Keluaran Farmaseutikal.

Upon receipt of complete application, the certificate shall be issued within fifteen (15) working days.

4.2.4

Drug Master File or CEP Certificate including Annexes for the API.

• Active Pharmaceutical Ingredient (API)
• Declaration Letter for An Approved API in New Product Registration Application
• Declaration on GMP of API Intermediate
• Guidance Notes Required Documents for API Information Version 1.0
• API Administrative Procedure QUEST3+
• Template Letter for API Submission to PKK
• Template Letter for API Submission to PPP
• Guideline on Submission of Documentation for a Multisource (Generic) Finished Pharmaceutical Product (FPP) Quality Part
• WHO Technical Report Series, No. 953, 2009 Annex 2 Stability testing of Active Pharmaceutical Ingredients and Finished Pharmaceutical Products
• Summary Of Required Documents For API Information August 2017

NOTE: APPENDIX 6 OF DRGD (TO GET CONFIRMATION FROM API TEAM)

4.2.5

Zone IVB Stability data (according to ASEAN Stability Guidelines) – min. 12 months real time data (30^oC C/75% RH) and 6 months accelerated conditions (40^oC/75% RH)

• For imported and exported product - min. 3 batches
• For locally manufactured product - min. 1 batch
• ASEAN Guideline on Stability Study of Drug Product 2013 (20th ACCSQ PPWG)
• ASEAN 1st Q & A to the ASEAN Stability Guideline R1 (21st ACCSQ PPWG)

4.2.6

Process Validation Report (according to ASEAN Guidelines).

• For imported and exported product – 3 consecutive commercial batches
• For locally manufactured product – PV Protocol, PV report (1 pilot batch), PDR Report and commitment letter
• ASEAN Guideline on Submission of Manufacturing Process Validation Data for Drug Registration
• Annex A1 Guidance on Process Validation Scheme for Solid Oral Dosage Products
• Annex A2 Guidance on Process Validation Scheme for Aseptically Processed Products
• Annex A3 Guidance on Process Validation Scheme for Terminally Scheme for Terminally Sterilized Products
• Annex B Table of Content of Process Validation Documentation
• Annex D Glossary
• Pekeliling Tarikh Kuatkuasa Keperluan Baru Option 2 Validasi Proses Untuk Permohonan Baru Produk Farmaseutikal Dan Permohonan Variasi

4.2.7

Analytical Validation Report (according to ASEAN Guidelines) and Analytical procedure.

-          ASEAN Guidelines for Validation of Analytical Procedures

-          Guidance for protocol of Analysis

-          ICH website: Validation of analytical procedures texts and methodology Q2 (R1) [Download Q2(R1)]

-          API Administrative Procedure QUEST 3+

-          Template Letter for API Submission to PKK

-          ASEAN guidelines on Validation

-          NPRA website à Guideline Central à API à

(ICH reference is not listed in DRGD nor the NPRA website. Need to pull from ICH website)

4.2.8

Bioequivalence (BE) Study Report for Generic Products (according to ASEAN Guidelines).

-          Bioequivalence (BE)

-          Bioequivalence Study Reporting

4.2.9

Accreditation of Bioequivalence Center

1.       Page 202 & 203 of DRGD

2.       Relevant Directives under this link in NPRA website: Laman utama -> direktif -> lihat semua -> tab bioequivalence (BE)

http://npra.moh.gov.my/images/Circulars_Directive/Bioequivalence_BE/Direktif_Pusat_kajian_BE_1-1.pdf

http://npra.moh.gov.my/images/Circulars_Directive/Bioequivalence_BE/makluman-susulan-berkaitan-BE_120913-1.pdf

http://npra.moh.gov.my/images/Circulars_Directive/Bioequivalence_BE/img-602165902.pdf

http://npra.moh.gov.my/images/Circulars_Directive/Bioequivalence_BE/Direktif-Penguatkuasaan-BE_Effervescent-Dispersible-Etc-2.pdf

http://npra.moh.gov.my/images/Circulars_Directive/Bioequivalence_BE/160315_Kelulusan_Had_Maksimum_Yuran_Pemeriksaan_BE_dan_GLP.pdf

http://npra.moh.gov.my/images/Circulars_Directive/Bioequivalence_BE/160601_Lanjutan_Tarikh_Penguatkuasaan_untuk_Memenuhi_Keperluan_Kajian_Bioekuivalens_bagi_Produk_Generik.pdf

3.       NPRA website -> garis panduan-> tab clinical trial

http://npra.moh.gov.my/images/Guidelines_Central/Guidelines_on_Clinical_Trial/Malaysia%20Guideline%20for%20BE%20Inspection%20(5-9-14)%20-%20Final.pdf

4.       NPRA website -> industries -> regulatory information -> bioequivalence (BE) -> BE Studies Center

http://npra.moh.gov.my/index.php/regulatory-information/bioequivalence-be

5.       NPRA website -> industries -> application forms -> clinical trial forms

·         Borang PKPB/300/521

·         Borang PKPB/300/531   

·         Borang PKPB/300/551

·         Borang PKPB/300/552

1

Apply QUEST 3+ Token

To conduct transactions for product registration, variation, licensing, renewal and other related transactions, you must register your membership and purchase your digital certificate in the form of USB token. Once you have obtained and installed your digital certificate, you will be able to conduct your transactions in QUEST 3+.

i.                     Apply Token HERE

ii.                   Read QUEST 3+ User Manual

2

Product classification

Before submission of application for a product registration, applicants may submit for product classification if unsure of the product category.

i.                     Download Product Classification Form

ii.                   Download Drug Regulation Guidance Document (DRGD)

iii.                 Download related Directive and Circular

3

Payment Mode

Three payment option available for applicants:

a.       Payment using company account (need to register company)

b.       Payment using personal credit card

c.       Cash Payment

4

Product Category: Generic (Scheduled Poison)

4.1

Patent and Data Exclusivity status

For the purpose of registration of generic products, Product Registration Holder shall provide patent declarations as below:

         i.            Product Registration Holder shall comply with all legal provisions in Malaysia;

       ii.            The government/ authority is not liable for any offence committed by the Product Registration Holder as a result of any breach of any law; and

     iii.            Product Registration Holder shall indemnify the government if any claim is made against the government as a result of any breach of any law by the applicant whether intentionally or otherwise.

Product Registration Holder shall conform to Patent Act 1983 (Act 291) and shall not market, sell, offer for sale, or store any registered product containing any patented active ingredient(s) of which the patent duration is yet to expire.

[Check Data Exclusivity List HERE]

4.2

Ensure availability of the following key documents.

This following list is not exhaustive, for details information, refer to checklist.

4.2.1

Registration dossiers in ICH CTD / ASEAN CTD format.

i.                     ICH CTD

ii.                   ASEAN CTD

Ø  Organization of the Dossier

Ø  Glossary used for the ACTD and ACTR

Ø  Part II: Quality

Ø  Part III: Nonclinical Document

Ø  Part IV: Clinical Document

Ø  ACTD Clinical Check List for Product Classification

Glossary:

ICH - The International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use

CTD - Common Technical Document

4.2.2

GMP certificate status.

Local Manufacturer - Issued by National Pharmaceutical Regulatory Agency (NPRA) as stated in Drug Regulation Guidance Document (DRGD)

Note to follow for international manufacturer:

·                     PIC/S member countries (https://picscheme.org/en/members)

·                     Non-PIC/S member countries. GMP inspection by National Pharmaceutical Regulatory Agency (NPRA) GMP Inspectors is required.

Ø  Good Manufacturing Practice/Good Distribution Practice

Ø  Guidance Document Foreign GMP Inspection March 2018

Ø  Dokumen Panduan Keperluan Direktif Bilangan 2 Tahun 2014 dan Bilangan 2 Tahun 2015

4.2.3

CPP Certificate in WHO format (For imported product only).

A Certificate of Pharmaceutical Product which follows the format recommended by WHO shall be issued to locally manufactured products that are to be exported. For application of CPP, applicant shall fill in form BPFK 412.2: Permohonan Perakuan Keluaran Farmaseutikal.

Upon receipt of complete application, the certificate shall be issued within fifteen (15) working days.

4.2.4

Drug Master File or CEP Certificate including Annexes for the API.

• Active Pharmaceutical Ingredient (API)
• Declaration Letter for An Approved API in New Product Registration Application
• Declaration on GMP of API Intermediate
• Guidance Notes Required Documents for API Information Version 1.0
• API Administrative Procedure QUEST3+
• Template Letter for API Submission to PKK
• Template Letter for API Submission to PPP
• Guideline on Submission of Documentation for a Multisource (Generic) Finished Pharmaceutical Product (FPP) Quality Part
• WHO Technical Report Series, No. 953, 2009 Annex 2 Stability testing of Active Pharmaceutical Ingredients and Finished Pharmaceutical Products
• Summary Of Required Documents For API Information August 2017

NOTE: APPENDIX 6 OF DRGD (TO GET CONFIRMATION FROM API TEAM)

4.2.5

Zone IVB Stability data (according to ASEAN Stability Guidelines) – min. 12 months real time data (30^oC C/75% RH) and 6 months accelerated conditions (40^oC/75% RH)

• For imported and exported product - min. 3 batches
• For locally manufactured product - min. 1 batch
• ASEAN Guideline on Stability Study of Drug Product 2013 (20th ACCSQ PPWG)
• ASEAN 1st Q & A to the ASEAN Stability Guideline R1 (21st ACCSQ PPWG)

4.2.6

Process Validation Report (according to ASEAN Guidelines).

• For imported and exported product – 3 consecutive commercial batches
• For locally manufactured product – PV Protocol, PV report (1 pilot batch), PDR Report and commitment letter
• ASEAN Guideline on Submission of Manufacturing Process Validation Data for Drug Registration
• Annex A1 Guidance on Process Validation Scheme for Solid Oral Dosage Products
• Annex A2 Guidance on Process Validation Scheme for Aseptically Processed Products
• Annex A3 Guidance on Process Validation Scheme for Terminally Scheme for Terminally Sterilized Products
• Annex B Table of Content of Process Validation Documentation
• Annex D Glossary
• Pekeliling Tarikh Kuatkuasa Keperluan Baru Option 2 Validasi Proses Untuk Permohonan Baru Produk Farmaseutikal Dan Permohonan Variasi

4.2.7

Analytical Validation Report (according to ASEAN Guidelines) and Analytical procedure.

-          ASEAN Guidelines for Validation of Analytical Procedures

-          Guidance for protocol of Analysis

-          ICH website: Validation of analytical procedures texts and methodology Q2 (R1) [Download Q2(R1)]

-          API Administrative Procedure QUEST 3+

-          Template Letter for API Submission to PKK

-          ASEAN guidelines on Validation

-          NPRA website à Guideline Central à API à

(ICH reference is not listed in DRGD nor the NPRA website. Need to pull from ICH website)

4.2.8

Bioequivalence (BE) Study Report for Generic Products (according to ASEAN Guidelines).

-          Bioequivalence (BE)

-          Bioequivalence Study Reporting

4.2.9

Accreditation of Bioequivalence Center

1.       Page 202 & 203 of DRGD

2.       Relevant Directives under this link in NPRA website: Laman utama -> direktif -> lihat semua -> tab bioequivalence (BE)

http://npra.moh.gov.my/images/Circulars_Directive/Bioequivalence_BE/Direktif_Pusat_kajian_BE_1-1.pdf

http://npra.moh.gov.my/images/Circulars_Directive/Bioequivalence_BE/makluman-susulan-berkaitan-BE_120913-1.pdf

http://npra.moh.gov.my/images/Circulars_Directive/Bioequivalence_BE/img-602165902.pdf

http://npra.moh.gov.my/images/Circulars_Directive/Bioequivalence_BE/Direktif-Penguatkuasaan-BE_Effervescent-Dispersible-Etc-2.pdf

http://npra.moh.gov.my/images/Circulars_Directive/Bioequivalence_BE/160315_Kelulusan_Had_Maksimum_Yuran_Pemeriksaan_BE_dan_GLP.pdf

http://npra.moh.gov.my/images/Circulars_Directive/Bioequivalence_BE/160601_Lanjutan_Tarikh_Penguatkuasaan_untuk_Memenuhi_Keperluan_Kajian_Bioekuivalens_bagi_Produk_Generik.pdf

3.       NPRA website -> garis panduan-> tab clinical trial

http://npra.moh.gov.my/images/Guidelines_Central/Guidelines_on_Clinical_Trial/Malaysia%20Guideline%20for%20BE%20Inspection%20(5-9-14)%20-%20Final.pdf

4.       NPRA website -> industries -> regulatory information -> bioequivalence (BE) -> BE Studies Center

http://npra.moh.gov.my/index.php/regulatory-information/bioequivalence-be

5.       NPRA website -> industries -> application forms -> clinical trial forms

·         Borang PKPB/300/521

·         Borang PKPB/300/531   

·         Borang PKPB/300/551

·         Borang PKPB/300/552

1

Apply QUEST 3+ Token

To conduct transactions for product registration, variation, licensing, renewal and other related transactions, you must register your membership and purchase your digital certificate in the form of USB token. Once you have obtained and installed your digital certificate, you will be able to conduct your transactions in QUEST 3+.

i.                     Apply Token HERE

ii.                   Read QUEST 3+ User Manual

2

Product classification

Before submission of application for a product registration, applicants may submit for product classification if unsure of the product category.

i.                     Download Product Classification Form

ii.                   Download Drug Regulation Guidance Document (DRGD)

iii.                 Download related Directive and Circular

3

Payment Mode

Three payment option available for applicants:

a.       Payment using company account (need to register company)

b.       Payment using personal credit card

c.       Cash Payment

4

Product Category: Generic (Scheduled Poison)

4.1

Patent and Data Exclusivity status

For the purpose of registration of generic products, Product Registration Holder shall provide patent declarations as below:

         i.            Product Registration Holder shall comply with all legal provisions in Malaysia;

       ii.            The government/ authority is not liable for any offence committed by the Product Registration Holder as a result of any breach of any law; and

     iii.            Product Registration Holder shall indemnify the government if any claim is made against the government as a result of any breach of any law by the applicant whether intentionally or otherwise.

Product Registration Holder shall conform to Patent Act 1983 (Act 291) and shall not market, sell, offer for sale, or store any registered product containing any patented active ingredient(s) of which the patent duration is yet to expire.

[Check Data Exclusivity List HERE]

4.2

Ensure availability of the following key documents.

This following list is not exhaustive, for details information, refer to checklist.

4.2.1

Registration dossiers in ICH CTD / ASEAN CTD format.

i.                     ICH CTD

ii.                   ASEAN CTD

Ø  Organization of the Dossier

Ø  Glossary used for the ACTD and ACTR

Ø  Part II: Quality

Ø  Part III: Nonclinical Document

Ø  Part IV: Clinical Document

Ø  ACTD Clinical Check List for Product Classification

Glossary:

ICH - The International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use

CTD - Common Technical Document

4.2.2

GMP certificate status.

Local Manufacturer - Issued by National Pharmaceutical Regulatory Agency (NPRA) as stated in Drug Regulation Guidance Document (DRGD)

Note to follow for international manufacturer:

·                     PIC/S member countries (https://picscheme.org/en/members)

·                     Non-PIC/S member countries. GMP inspection by National Pharmaceutical Regulatory Agency (NPRA) GMP Inspectors is required.

Ø  Good Manufacturing Practice/Good Distribution Practice

Ø  Guidance Document Foreign GMP Inspection March 2018

Ø  Dokumen Panduan Keperluan Direktif Bilangan 2 Tahun 2014 dan Bilangan 2 Tahun 2015

4.2.3

CPP Certificate in WHO format (For imported product only).

A Certificate of Pharmaceutical Product which follows the format recommended by WHO shall be issued to locally manufactured products that are to be exported. For application of CPP, applicant shall fill in form BPFK 412.2: Permohonan Perakuan Keluaran Farmaseutikal.

Upon receipt of complete application, the certificate shall be issued within fifteen (15) working days.

4.2.4

Drug Master File or CEP Certificate including Annexes for the API.

• Active Pharmaceutical Ingredient (API)
• Declaration Letter for An Approved API in New Product Registration Application
• Declaration on GMP of API Intermediate
• Guidance Notes Required Documents for API Information Version 1.0
• API Administrative Procedure QUEST3+
• Template Letter for API Submission to PKK
• Template Letter for API Submission to PPP
• Guideline on Submission of Documentation for a Multisource (Generic) Finished Pharmaceutical Product (FPP) Quality Part
• WHO Technical Report Series, No. 953, 2009 Annex 2 Stability testing of Active Pharmaceutical Ingredients and Finished Pharmaceutical Products
• Summary Of Required Documents For API Information August 2017

NOTE: APPENDIX 6 OF DRGD (TO GET CONFIRMATION FROM API TEAM)

4.2.5

Zone IVB Stability data (according to ASEAN Stability Guidelines) – min. 12 months real time data (30^oC C/75% RH) and 6 months accelerated conditions (40^oC/75% RH)

• For imported and exported product - min. 3 batches
• For locally manufactured product - min. 1 batch
• ASEAN Guideline on Stability Study of Drug Product 2013 (20th ACCSQ PPWG)
• ASEAN 1st Q & A to the ASEAN Stability Guideline R1 (21st ACCSQ PPWG)

4.2.6

Process Validation Report (according to ASEAN Guidelines).

• For imported and exported product – 3 consecutive commercial batches
• For locally manufactured product – PV Protocol, PV report (1 pilot batch), PDR Report and commitment letter
• ASEAN Guideline on Submission of Manufacturing Process Validation Data for Drug Registration
• Annex A1 Guidance on Process Validation Scheme for Solid Oral Dosage Products
• Annex A2 Guidance on Process Validation Scheme for Aseptically Processed Products
• Annex A3 Guidance on Process Validation Scheme for Terminally Scheme for Terminally Sterilized Products
• Annex B Table of Content of Process Validation Documentation
• Annex D Glossary
• Pekeliling Tarikh Kuatkuasa Keperluan Baru Option 2 Validasi Proses Untuk Permohonan Baru Produk Farmaseutikal Dan Permohonan Variasi

4.2.7

Analytical Validation Report (according to ASEAN Guidelines) and Analytical procedure.

-          ASEAN Guidelines for Validation of Analytical Procedures

-          Guidance for protocol of Analysis

-          ICH website: Validation of analytical procedures texts and methodology Q2 (R1) [Download Q2(R1)]

-          API Administrative Procedure QUEST 3+

-          Template Letter for API Submission to PKK

-          ASEAN guidelines on Validation

-          NPRA website à Guideline Central à API à

(ICH reference is not listed in DRGD nor the NPRA website. Need to pull from ICH website)

4.2.8

Bioequivalence (BE) Study Report for Generic Products (according to ASEAN Guidelines).

-          Bioequivalence (BE)

-          Bioequivalence Study Reporting

4.2.9

Accreditation of Bioequivalence Center

1.       Page 202 & 203 of DRGD

2.       Relevant Directives under this link in NPRA website: Laman utama -> direktif -> lihat semua -> tab bioequivalence (BE)

http://npra.moh.gov.my/images/Circulars_Directive/Bioequivalence_BE/Direktif_Pusat_kajian_BE_1-1.pdf

http://npra.moh.gov.my/images/Circulars_Directive/Bioequivalence_BE/makluman-susulan-berkaitan-BE_120913-1.pdf

http://npra.moh.gov.my/images/Circulars_Directive/Bioequivalence_BE/img-602165902.pdf

http://npra.moh.gov.my/images/Circulars_Directive/Bioequivalence_BE/Direktif-Penguatkuasaan-BE_Effervescent-Dispersible-Etc-2.pdf

http://npra.moh.gov.my/images/Circulars_Directive/Bioequivalence_BE/160315_Kelulusan_Had_Maksimum_Yuran_Pemeriksaan_BE_dan_GLP.pdf

http://npra.moh.gov.my/images/Circulars_Directive/Bioequivalence_BE/160601_Lanjutan_Tarikh_Penguatkuasaan_untuk_Memenuhi_Keperluan_Kajian_Bioekuivalens_bagi_Produk_Generik.pdf

3.       NPRA website -> garis panduan-> tab clinical trial

http://npra.moh.gov.my/images/Guidelines_Central/Guidelines_on_Clinical_Trial/Malaysia%20Guideline%20for%20BE%20Inspection%20(5-9-14)%20-%20Final.pdf

4.       NPRA website -> industries -> regulatory information -> bioequivalence (BE) -> BE Studies Center

http://npra.moh.gov.my/index.php/regulatory-information/bioequivalence-be

5.       NPRA website -> industries -> application forms -> clinical trial forms

·         Borang PKPB/300/521

·         Borang PKPB/300/531   

·         Borang PKPB/300/551

·         Borang PKPB/300/552

1

Apply QUEST 3+ Token

To conduct transactions for product registration, variation, licensing, renewal and other related transactions, you must register your membership and purchase your digital certificate in the form of USB token. Once you have obtained and installed your digital certificate, you will be able to conduct your transactions in QUEST 3+.

i.                     Apply Token HERE

ii.                   Read QUEST 3+ User Manual

2

Product classification

Before submission of application for a product registration, applicants may submit for product classification if unsure of the product category.

i.                     Download Product Classification Form

ii.                   Download Drug Regulation Guidance Document (DRGD)

iii.                 Download related Directive and Circular

3

Payment Mode

Three payment option available for applicants:

a.       Payment using company account (need to register company)

b.       Payment using personal credit card

c.       Cash Payment

4

Product Category: Generic (Scheduled Poison)

4.1

Patent and Data Exclusivity status

For the purpose of registration of generic products, Product Registration Holder shall provide patent declarations as below:

         i.            Product Registration Holder shall comply with all legal provisions in Malaysia;

       ii.            The government/ authority is not liable for any offence committed by the Product Registration Holder as a result of any breach of any law; and

     iii.            Product Registration Holder shall indemnify the government if any claim is made against the government as a result of any breach of any law by the applicant whether intentionally or otherwise.

Product Registration Holder shall conform to Patent Act 1983 (Act 291) and shall not market, sell, offer for sale, or store any registered product containing any patented active ingredient(s) of which the patent duration is yet to expire.

[Check Data Exclusivity List HERE]

4.2

Ensure availability of the following key documents.

This following list is not exhaustive, for details information, refer to checklist.

4.2.1

Registration dossiers in ICH CTD / ASEAN CTD format.

i.                     ICH CTD

ii.                   ASEAN CTD

Ø  Organization of the Dossier

Ø  Glossary used for the ACTD and ACTR

Ø  Part II: Quality

Ø  Part III: Nonclinical Document

Ø  Part IV: Clinical Document

Ø  ACTD Clinical Check List for Product Classification

Glossary:

ICH - The International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use

CTD - Common Technical Document

4.2.2

GMP certificate status.

Local Manufacturer - Issued by National Pharmaceutical Regulatory Agency (NPRA) as stated in Drug Regulation Guidance Document (DRGD)

Note to follow for international manufacturer:

·                     PIC/S member countries (https://picscheme.org/en/members)

·                     Non-PIC/S member countries. GMP inspection by National Pharmaceutical Regulatory Agency (NPRA) GMP Inspectors is required.

Ø  Good Manufacturing Practice/Good Distribution Practice

Ø  Guidance Document Foreign GMP Inspection March 2018

Ø  Dokumen Panduan Keperluan Direktif Bilangan 2 Tahun 2014 dan Bilangan 2 Tahun 2015

4.2.3

CPP Certificate in WHO format (For imported product only).

A Certificate of Pharmaceutical Product which follows the format recommended by WHO shall be issued to locally manufactured products that are to be exported. For application of CPP, applicant shall fill in form BPFK 412.2: Permohonan Perakuan Keluaran Farmaseutikal.

Upon receipt of complete application, the certificate shall be issued within fifteen (15) working days.

4.2.4

Drug Master File or CEP Certificate including Annexes for the API.

• Active Pharmaceutical Ingredient (API)
• Declaration Letter for An Approved API in New Product Registration Application
• Declaration on GMP of API Intermediate
• Guidance Notes Required Documents for API Information Version 1.0
• API Administrative Procedure QUEST3+
• Template Letter for API Submission to PKK
• Template Letter for API Submission to PPP
• Guideline on Submission of Documentation for a Multisource (Generic) Finished Pharmaceutical Product (FPP) Quality Part
• WHO Technical Report Series, No. 953, 2009 Annex 2 Stability testing of Active Pharmaceutical Ingredients and Finished Pharmaceutical Products
• Summary Of Required Documents For API Information August 2017

NOTE: APPENDIX 6 OF DRGD (TO GET CONFIRMATION FROM API TEAM)

4.2.5

Zone IVB Stability data (according to ASEAN Stability Guidelines) – min. 12 months real time data (30^oC C/75% RH) and 6 months accelerated conditions (40^oC/75% RH)

• For imported and exported product - min. 3 batches
• For locally manufactured product - min. 1 batch
• ASEAN Guideline on Stability Study of Drug Product 2013 (20th ACCSQ PPWG)
• ASEAN 1st Q & A to the ASEAN Stability Guideline R1 (21st ACCSQ PPWG)

4.2.6

Process Validation Report (according to ASEAN Guidelines).

• For imported and exported product – 3 consecutive commercial batches
• For locally manufactured product – PV Protocol, PV report (1 pilot batch), PDR Report and commitment letter
• ASEAN Guideline on Submission of Manufacturing Process Validation Data for Drug Registration
• Annex A1 Guidance on Process Validation Scheme for Solid Oral Dosage Products
• Annex A2 Guidance on Process Validation Scheme for Aseptically Processed Products
• Annex A3 Guidance on Process Validation Scheme for Terminally Scheme for Terminally Sterilized Products
• Annex B Table of Content of Process Validation Documentation
• Annex D Glossary
• Pekeliling Tarikh Kuatkuasa Keperluan Baru Option 2 Validasi Proses Untuk Permohonan Baru Produk Farmaseutikal Dan Permohonan Variasi

4.2.7

Analytical Validation Report (according to ASEAN Guidelines) and Analytical procedure.

-          ASEAN Guidelines for Validation of Analytical Procedures

-          Guidance for protocol of Analysis

-          ICH website: Validation of analytical procedures texts and methodology Q2 (R1) [Download Q2(R1)]

-          API Administrative Procedure QUEST 3+

-          Template Letter for API Submission to PKK

-          ASEAN guidelines on Validation

-          NPRA website à Guideline Central à API à

(ICH reference is not listed in DRGD nor the NPRA website. Need to pull from ICH website)

4.2.8

Bioequivalence (BE) Study Report for Generic Products (according to ASEAN Guidelines).

-          Bioequivalence (BE)

-          Bioequivalence Study Reporting

4.2.9

Accreditation of Bioequivalence Center

1.       Page 202 & 203 of DRGD

2.       Relevant Directives under this link in NPRA website: Laman utama -> direktif -> lihat semua -> tab bioequivalence (BE)

http://npra.moh.gov.my/images/Circulars_Directive/Bioequivalence_BE/Direktif_Pusat_kajian_BE_1-1.pdf

http://npra.moh.gov.my/images/Circulars_Directive/Bioequivalence_BE/makluman-susulan-berkaitan-BE_120913-1.pdf

http://npra.moh.gov.my/images/Circulars_Directive/Bioequivalence_BE/img-602165902.pdf

http://npra.moh.gov.my/images/Circulars_Directive/Bioequivalence_BE/Direktif-Penguatkuasaan-BE_Effervescent-Dispersible-Etc-2.pdf

http://npra.moh.gov.my/images/Circulars_Directive/Bioequivalence_BE/160315_Kelulusan_Had_Maksimum_Yuran_Pemeriksaan_BE_dan_GLP.pdf

http://npra.moh.gov.my/images/Circulars_Directive/Bioequivalence_BE/160601_Lanjutan_Tarikh_Penguatkuasaan_untuk_Memenuhi_Keperluan_Kajian_Bioekuivalens_bagi_Produk_Generik.pdf

3.       NPRA website -> garis panduan-> tab clinical trial

http://npra.moh.gov.my/images/Guidelines_Central/Guidelines_on_Clinical_Trial/Malaysia%20Guideline%20for%20BE%20Inspection%20(5-9-14)%20-%20Final.pdf

4.       NPRA website -> industries -> regulatory information -> bioequivalence (BE) -> BE Studies Center

http://npra.moh.gov.my/index.php/regulatory-information/bioequivalence-be

5.       NPRA website -> industries -> application forms -> clinical trial forms

·         Borang PKPB/300/521

·         Borang PKPB/300/531   

·         Borang PKPB/300/551

·         Borang PKPB/300/552

1

Apply QUEST 3+ Token

To conduct transactions for product registration, variation, licensing, renewal and other related transactions, you must register your membership and purchase your digital certificate in the form of USB token. Once you have obtained and installed your digital certificate, you will be able to conduct your transactions in QUEST 3+.

i.                     Apply Token HERE

ii.                   Read QUEST 3+ User Manual

2

Product classification

Before submission of application for a product registration, applicants may submit for product classification if unsure of the product category.

i.                     Download Product Classification Form

ii.                   Download Drug Regulation Guidance Document (DRGD)

iii.                 Download related Directive and Circular

3

Payment Mode

Three payment option available for applicants:

a.       Payment using company account (need to register company)

b.       Payment using personal credit card

c.       Cash Payment

4

Product Category: Generic (Scheduled Poison)

4.1

Patent and Data Exclusivity status

For the purpose of registration of generic products, Product Registration Holder shall provide patent declarations as below:

         i.            Product Registration Holder shall comply with all legal provisions in Malaysia;

       ii.            The government/ authority is not liable for any offence committed by the Product Registration Holder as a result of any breach of any law; and

     iii.            Product Registration Holder shall indemnify the government if any claim is made against the government as a result of any breach of any law by the applicant whether intentionally or otherwise.

Product Registration Holder shall conform to Patent Act 1983 (Act 291) and shall not market, sell, offer for sale, or store any registered product containing any patented active ingredient(s) of which the patent duration is yet to expire.

[Check Data Exclusivity List HERE]

4.2

Ensure availability of the following key documents.

This following list is not exhaustive, for details information, refer to checklist.

4.2.1

Registration dossiers in ICH CTD / ASEAN CTD format.

i.                     ICH CTD

ii.                   ASEAN CTD

Ø  Organization of the Dossier

Ø  Glossary used for the ACTD and ACTR

Ø  Part II: Quality

Ø  Part III: Nonclinical Document

Ø  Part IV: Clinical Document

Ø  ACTD Clinical Check List for Product Classification

Glossary:

ICH - The International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use

CTD - Common Technical Document

4.2.2

GMP certificate status.

Local Manufacturer - Issued by National Pharmaceutical Regulatory Agency (NPRA) as stated in Drug Regulation Guidance Document (DRGD)

Note to follow for international manufacturer:

·                     PIC/S member countries (https://picscheme.org/en/members)

·                     Non-PIC/S member countries. GMP inspection by National Pharmaceutical Regulatory Agency (NPRA) GMP Inspectors is required.

Ø  Good Manufacturing Practice/Good Distribution Practice

Ø  Guidance Document Foreign GMP Inspection March 2018

Ø  Dokumen Panduan Keperluan Direktif Bilangan 2 Tahun 2014 dan Bilangan 2 Tahun 2015

4.2.3

CPP Certificate in WHO format (For imported product only).

A Certificate of Pharmaceutical Product which follows the format recommended by WHO shall be issued to locally manufactured products that are to be exported. For application of CPP, applicant shall fill in form BPFK 412.2: Permohonan Perakuan Keluaran Farmaseutikal.

Upon receipt of complete application, the certificate shall be issued within fifteen (15) working days.

4.2.4

Drug Master File or CEP Certificate including Annexes for the API.

• Active Pharmaceutical Ingredient (API)
• Declaration Letter for An Approved API in New Product Registration Application
• Declaration on GMP of API Intermediate
• Guidance Notes Required Documents for API Information Version 1.0
• API Administrative Procedure QUEST3+
• Template Letter for API Submission to PKK
• Template Letter for API Submission to PPP
• Guideline on Submission of Documentation for a Multisource (Generic) Finished Pharmaceutical Product (FPP) Quality Part
• WHO Technical Report Series, No. 953, 2009 Annex 2 Stability testing of Active Pharmaceutical Ingredients and Finished Pharmaceutical Products
• Summary Of Required Documents For API Information August 2017

NOTE: APPENDIX 6 OF DRGD (TO GET CONFIRMATION FROM API TEAM)

4.2.5

Zone IVB Stability data (according to ASEAN Stability Guidelines) – min. 12 months real time data (30^oC C/75% RH) and 6 months accelerated conditions (40^oC/75% RH)

• For imported and exported product - min. 3 batches
• For locally manufactured product - min. 1 batch
• ASEAN Guideline on Stability Study of Drug Product 2013 (20th ACCSQ PPWG)
• ASEAN 1st Q & A to the ASEAN Stability Guideline R1 (21st ACCSQ PPWG)

4.2.6

Process Validation Report (according to ASEAN Guidelines).

• For imported and exported product – 3 consecutive commercial batches
• For locally manufactured product – PV Protocol, PV report (1 pilot batch), PDR Report and commitment letter
• ASEAN Guideline on Submission of Manufacturing Process Validation Data for Drug Registration
• Annex A1 Guidance on Process Validation Scheme for Solid Oral Dosage Products
• Annex A2 Guidance on Process Validation Scheme for Aseptically Processed Products
• Annex A3 Guidance on Process Validation Scheme for Terminally Scheme for Terminally Sterilized Products
• Annex B Table of Content of Process Validation Documentation
• Annex D Glossary
• Pekeliling Tarikh Kuatkuasa Keperluan Baru Option 2 Validasi Proses Untuk Permohonan Baru Produk Farmaseutikal Dan Permohonan Variasi

4.2.7

Analytical Validation Report (according to ASEAN Guidelines) and Analytical procedure.

-          ASEAN Guidelines for Validation of Analytical Procedures

-          Guidance for protocol of Analysis

-          ICH website: Validation of analytical procedures texts and methodology Q2 (R1) [Download Q2(R1)]

-          API Administrative Procedure QUEST 3+

-          Template Letter for API Submission to PKK

-          ASEAN guidelines on Validation

-          NPRA website à Guideline Central à API à

(ICH reference is not listed in DRGD nor the NPRA website. Need to pull from ICH website)

4.2.8

Bioequivalence (BE) Study Report for Generic Products (according to ASEAN Guidelines).

-          Bioequivalence (BE)

-          Bioequivalence Study Reporting

4.2.9

Accreditation of Bioequivalence Center

1.       Page 202 & 203 of DRGD

2.       Relevant Directives under this link in NPRA website: Laman utama -> direktif -> lihat semua -> tab bioequivalence (BE)

http://npra.moh.gov.my/images/Circulars_Directive/Bioequivalence_BE/Direktif_Pusat_kajian_BE_1-1.pdf

http://npra.moh.gov.my/images/Circulars_Directive/Bioequivalence_BE/makluman-susulan-berkaitan-BE_120913-1.pdf

http://npra.moh.gov.my/images/Circulars_Directive/Bioequivalence_BE/img-602165902.pdf

http://npra.moh.gov.my/images/Circulars_Directive/Bioequivalence_BE/Direktif-Penguatkuasaan-BE_Effervescent-Dispersible-Etc-2.pdf

http://npra.moh.gov.my/images/Circulars_Directive/Bioequivalence_BE/160315_Kelulusan_Had_Maksimum_Yuran_Pemeriksaan_BE_dan_GLP.pdf

http://npra.moh.gov.my/images/Circulars_Directive/Bioequivalence_BE/160601_Lanjutan_Tarikh_Penguatkuasaan_untuk_Memenuhi_Keperluan_Kajian_Bioekuivalens_bagi_Produk_Generik.pdf

3.       NPRA website -> garis panduan-> tab clinical trial

http://npra.moh.gov.my/images/Guidelines_Central/Guidelines_on_Clinical_Trial/Malaysia%20Guideline%20for%20BE%20Inspection%20(5-9-14)%20-%20Final.pdf

4.       NPRA website -> industries -> regulatory information -> bioequivalence (BE) -> BE Studies Center

http://npra.moh.gov.my/index.php/regulatory-information/bioequivalence-be

5.       NPRA website -> industries -> application forms -> clinical trial forms

·         Borang PKPB/300/521

·         Borang PKPB/300/531   

·         Borang PKPB/300/551

·         Borang PKPB/300/552

1

Apply QUEST 3+ Token

To conduct transactions for product registration, variation, licensing, renewal and other related transactions, you must register your membership and purchase your digital certificate in the form of USB token. Once you have obtained and installed your digital certificate, you will be able to conduct your transactions in QUEST 3+.

i.                     Apply Token HERE

ii.                   Read QUEST 3+ User Manual

2

Product classification

Before submission of application for a product registration, applicants may submit for product classification if unsure of the product category.

i.                     Download Product Classification Form

ii.                   Download Drug Regulation Guidance Document (DRGD)

iii.                 Download related Directive and Circular

3

Payment Mode

Three payment option available for applicants:

a.       Payment using company account (need to register company)

b.       Payment using personal credit card

c.       Cash Payment

4

Product Category: Generic (Scheduled Poison)

4.1

Patent and Data Exclusivity status

For the purpose of registration of generic products, Product Registration Holder shall provide patent declarations as below:

         i.            Product Registration Holder shall comply with all legal provisions in Malaysia;

       ii.            The government/ authority is not liable for any offence committed by the Product Registration Holder as a result of any breach of any law; and

     iii.            Product Registration Holder shall indemnify the government if any claim is made against the government as a result of any breach of any law by the applicant whether intentionally or otherwise.

Product Registration Holder shall conform to Patent Act 1983 (Act 291) and shall not market, sell, offer for sale, or store any registered product containing any patented active ingredient(s) of which the patent duration is yet to expire.

[Check Data Exclusivity List HERE]

4.2

Ensure availability of the following key documents.

This following list is not exhaustive, for details information, refer to checklist.

4.2.1

Registration dossiers in ICH CTD / ASEAN CTD format.

i.                     ICH CTD

ii.                   ASEAN CTD

Ø  Organization of the Dossier

Ø  Glossary used for the ACTD and ACTR

Ø  Part II: Quality

Ø  Part III: Nonclinical Document

Ø  Part IV: Clinical Document

Ø  ACTD Clinical Check List for Product Classification

Glossary:

ICH - The International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use

CTD - Common Technical Document

4.2.2

GMP certificate status.

Local Manufacturer - Issued by National Pharmaceutical Regulatory Agency (NPRA) as stated in Drug Regulation Guidance Document (DRGD)

Note to follow for international manufacturer:

·                     PIC/S member countries (https://picscheme.org/en/members)

·                     Non-PIC/S member countries. GMP inspection by National Pharmaceutical Regulatory Agency (NPRA) GMP Inspectors is required.

Ø  Good Manufacturing Practice/Good Distribution Practice

Ø  Guidance Document Foreign GMP Inspection March 2018

Ø  Dokumen Panduan Keperluan Direktif Bilangan 2 Tahun 2014 dan Bilangan 2 Tahun 2015

4.2.3

CPP Certificate in WHO format (For imported product only).

A Certificate of Pharmaceutical Product which follows the format recommended by WHO shall be issued to locally manufactured products that are to be exported. For application of CPP, applicant shall fill in form BPFK 412.2: Permohonan Perakuan Keluaran Farmaseutikal.

Upon receipt of complete application, the certificate shall be issued within fifteen (15) working days.

4.2.4

Drug Master File or CEP Certificate including Annexes for the API.

• Active Pharmaceutical Ingredient (API)
• Declaration Letter for An Approved API in New Product Registration Application
• Declaration on GMP of API Intermediate
• Guidance Notes Required Documents for API Information Version 1.0
• API Administrative Procedure QUEST3+
• Template Letter for API Submission to PKK
• Template Letter for API Submission to PPP
• Guideline on Submission of Documentation for a Multisource (Generic) Finished Pharmaceutical Product (FPP) Quality Part
• WHO Technical Report Series, No. 953, 2009 Annex 2 Stability testing of Active Pharmaceutical Ingredients and Finished Pharmaceutical Products
• Summary Of Required Documents For API Information August 2017

NOTE: APPENDIX 6 OF DRGD (TO GET CONFIRMATION FROM API TEAM)

4.2.5

Zone IVB Stability data (according to ASEAN Stability Guidelines) – min. 12 months real time data (30^oC C/75% RH) and 6 months accelerated conditions (40^oC/75% RH)

• For imported and exported product - min. 3 batches
• For locally manufactured product - min. 1 batch
• ASEAN Guideline on Stability Study of Drug Product 2013 (20th ACCSQ PPWG)
• ASEAN 1st Q & A to the ASEAN Stability Guideline R1 (21st ACCSQ PPWG)

4.2.6

Process Validation Report (according to ASEAN Guidelines).

• For imported and exported product – 3 consecutive commercial batches
• For locally manufactured product – PV Protocol, PV report (1 pilot batch), PDR Report and commitment letter
• ASEAN Guideline on Submission of Manufacturing Process Validation Data for Drug Registration
• Annex A1 Guidance on Process Validation Scheme for Solid Oral Dosage Products
• Annex A2 Guidance on Process Validation Scheme for Aseptically Processed Products
• Annex A3 Guidance on Process Validation Scheme for Terminally Scheme for Terminally Sterilized Products
• Annex B Table of Content of Process Validation Documentation
• Annex D Glossary
• Pekeliling Tarikh Kuatkuasa Keperluan Baru Option 2 Validasi Proses Untuk Permohonan Baru Produk Farmaseutikal Dan Permohonan Variasi

4.2.7

Analytical Validation Report (according to ASEAN Guidelines) and Analytical procedure.

-          ASEAN Guidelines for Validation of Analytical Procedures

-          Guidance for protocol of Analysis

-          ICH website: Validation of analytical procedures texts and methodology Q2 (R1) [Download Q2(R1)]

-          API Administrative Procedure QUEST 3+

-          Template Letter for API Submission to PKK

-          ASEAN guidelines on Validation

-          NPRA website à Guideline Central à API à

(ICH reference is not listed in DRGD nor the NPRA website. Need to pull from ICH website)

4.2.8

Bioequivalence (BE) Study Report for Generic Products (according to ASEAN Guidelines).

-          Bioequivalence (BE)

-          Bioequivalence Study Reporting

4.2.9

Accreditation of Bioequivalence Center

1.       Page 202 & 203 of DRGD

2.       Relevant Directives under this link in NPRA website: Laman utama -> direktif -> lihat semua -> tab bioequivalence (BE)

http://npra.moh.gov.my/images/Circulars_Directive/Bioequivalence_BE/Direktif_Pusat_kajian_BE_1-1.pdf

http://npra.moh.gov.my/images/Circulars_Directive/Bioequivalence_BE/makluman-susulan-berkaitan-BE_120913-1.pdf

http://npra.moh.gov.my/images/Circulars_Directive/Bioequivalence_BE/img-602165902.pdf

http://npra.moh.gov.my/images/Circulars_Directive/Bioequivalence_BE/Direktif-Penguatkuasaan-BE_Effervescent-Dispersible-Etc-2.pdf

http://npra.moh.gov.my/images/Circulars_Directive/Bioequivalence_BE/160315_Kelulusan_Had_Maksimum_Yuran_Pemeriksaan_BE_dan_GLP.pdf

http://npra.moh.gov.my/images/Circulars_Directive/Bioequivalence_BE/160601_Lanjutan_Tarikh_Penguatkuasaan_untuk_Memenuhi_Keperluan_Kajian_Bioekuivalens_bagi_Produk_Generik.pdf

3.       NPRA website -> garis panduan-> tab clinical trial

http://npra.moh.gov.my/images/Guidelines_Central/Guidelines_on_Clinical_Trial/Malaysia%20Guideline%20for%20BE%20Inspection%20(5-9-14)%20-%20Final.pdf

4.       NPRA website -> industries -> regulatory information -> bioequivalence (BE) -> BE Studies Center

http://npra.moh.gov.my/index.php/regulatory-information/bioequivalence-be

5.       NPRA website -> industries -> application forms -> clinical trial forms

·         Borang PKPB/300/521

·         Borang PKPB/300/531   

·         Borang PKPB/300/551

·         Borang PKPB/300/552