Step 1: Pre-submission of Application (Preparation) for New Chemical Entity

Step 1 of 4: Pre-submission of Application (Preparation)

1.1. 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. Register USB Token

ii. User Manual for each module

1.2. Product Classification

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

i. Product Classification Guideline

ii. Product Classification Form : Ms Word | PDF

1.3. Payment Mode

Online payment option available for applicants:

i. Payment Using Personal/Current Account - B2C

ii. Payment Using Corporate Account - B2B

iii. Payment Using Credit Card

1.4. Product Category: NCE (Scheduled Poison)

1.4.1 Patent and Data Exclusivity status

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

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

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

- 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.

ii. 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

1.4.2 Ensure availability of the following key documents.

1.4.2.1 Registration dossiers in ICH CTD / ASEAN CTD format.

i. Common Technical Document (CTD) required by The International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) Click ~> Go to ICH website

ii. Asean Common Technical Document (CTD)

- Organization of the Dossier

- Glossary used for the ACTD and ACTR

- Part II: Quality

- ACTD Clinical Check List for Product Classification

1.4.2.2 GMP certificate status.

For those companies interested to apply GMP certificate, company can download Borang Permohonan Sijil APB (BPFK-420).

i. Local Manufacturer - GMP certificate status issued by National Pharmaceutical Regulatory Agency (NPRA) as stated in Drug Regulation Guidance Document (DRGD).

ii. Guideline

- Good Manufacturing Practice / Good Distribution Practice

- Guidance Document Foreign GMP Inspection July 2018

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

iii. 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.

1.4.2.3 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 from QUEST 3+.

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

1.4.2.4 Information for Part II - Section S: Active Pharmaceutical Ingredient (API)

The API(s) information can be submitted through one of the following three options:

• Option 1: Drug Master File (DMF) procedure; or

• Option 2: Certificate of suitability of the European Pharmacopoeia (CEP); or

• Option 3: Full details of “Part II-S ACTD” in the Product Dossier

For further details please refer to link below:

- Regulatory Information : Active Pharmaceutical Ingredients (API)

- Appendix 6 : Guideline On Regulatory Control Of Active Pharmaceutical Ingredients (APIs)

1.4.2.5 Process Validation Report (according to ASEAN Guidelines).

i. For imported and exported product – 3 consecutive commercial batches

ii. For locally manufactured product – PV Protocol, PV report (1 pilot batch), PDR Report and commitment letter

For details, read the listed guideline:

- ASEAN Guideline on Submission of Manufacturing Process Validation Data for Drug Registration

- Annex A1 Guidance on Process Validation Scheme for Solid Oral Dosage Products