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+.
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: Biologics (Scheduled Poison)
1.4.1 Responsibilites of the applicant.
i. For the purpose of registration of biologics products, Product Registration Holder shall conform to the following:
- 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.
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)
- Glossary used for the ACTD and ACTR
- 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 or other PIC/S member countries 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
- Annex A2 Guidance on Process Validation Scheme for Aseptically Processed Products
- Annex B Table of Content of Process Validation Documentation
1.4.2.6 Analytical Validation Report (according to ASEAN Guidelines) and Analytical procedure.
For details, read the listed guideline:
i. ASEAN Guidelines for Validation of Analytical Procedures
ii. Guidance for protocol of Analysis
iii. ICH website: Validation of analytical procedures texts and methodology Q2 (R2) [Download Q2(R2)]
