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+.

  1. Register USB Token
  2. 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.

  1. Product Classification Form  : Ms Word|  PDF 

 

1.3. Payment Mode

Online payment option available for applicants:

  1. Payment Using Personal/Current Account - B2C
  2. Payment Using Corporate Account - B2B
  3. Payment Using Credit Card

 

1.4. Key Documents

1.4.2.1 Registration dossiers in CTD / ASEAN CTD format.

Please refer Glossary developed for the ACTD and ACTR. The definitions used in the glossary have been developed for the ASEAN Common Technical Dossier (ACTD) and Common Technical Requirements (ACTR).

1.4.2.2 GMP certificate status.

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

  1. Local Manufacturer- GMP certificate status issued by National Pharmaceutical Regulatory Agency (NPRA) as stated in Drug Regulation Guidance Document (DRGD).
  2. Guideline:
  1. 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 Drug Master File or CEP Certificate including Annexes for the API.

 Please submit if applicable

1.4.2.5 Stability data 

 For detailed information please refer to the ASEAN   Guideline on Stability Study of   Drug Product 2013 (20th   ACCSQ PPWG) at: ASEAN Guideline on Stability Study of   Drug Product 2013 Guideline For Stability Data:

ASEAN Guideline on Stability Study of Drug Product 2013
Guideline for Stability Data

1.4.2.6 Process Validation Report. 

 Please refer ASEAN Guidelines on Process Validation

1.4.2.7 Analytical Validation Report and Analytical procedure.

 For details, read the listed guideline:

  1. ASEAN Guidelines for Validation of Analytical Procedures

 

 

National Pharmaceutical Regulatory Agency (NPRA)
Lot 36, Jalan Universiti, 46200 Petaling Jaya, Selangor, Malaysia.
  • Email: npra@npra.gov.my
  • Phone: +603-7883 5400
  • Fax: +603-7956 2924, +603-7956 7075

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