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

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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 

iii. Product Classification Application Manual (NPRA 300.1)

 

1.3. Payment Mode

Online payment option available for applicants:

i. Payment Using Personal/Current Account - B2C

ii. Payment Using Corporate Account - B2B

ii. Payment Using Credit Card

 

1.4. Product Category: Generic (Scheduled Poison)

1.4.1 Patent and Data Exclusivity status

i. For the purpose of registration of generic 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

- Part III: Nonclinical Document

- Part IV: Clinical Document

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

Active Pharmaceutical Ingredients (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

1.4.2.5 Zone IVB Stability data (according to ASEAN Stability Guidelines)

Minimum 12 months real time data (30oC C / 75% RH) and 6 months accelerated conditions (40oC / 75% RH). 

i. For imported and exported product - minimum 3 batches

ii. For locally manufactured product - minimum 1 batch

For details, read the listed guideline:

- 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)

1.4.2.6 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 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

1.4.2.7 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 (R1) [Download Q2(R1)]

iv API Administrative Procedure QUEST 3+

v. Template Letter for API Submission to PKK

 

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

In general, for a second source application of a generic product (immediate release, oral solid dosage form), BE study report from the actual manufacturing site must be submitted during the submission of application for registration. The base of this requirement is due to the difference in manufacturing site from the first source that may change the characteristic and specifications of a second source product. However, biowaiver can be considered, provided that Comparative Dissolution Profile (CPD) report against the registered first source product is submitted as a surrogate to bioequivalence study conducted for the second source product and all the following conditions shall be fulfilled:

a) Bioequivalence study conducted using the registered first source product has been evaluated by the NPRA and found satisfactory.

b) The second source product is the same as registered first source product used in the bioequivalence study in terms of:

- Product formulation;

- Equipment used in the manufacturing process;

- Source and supplier of raw material;

- Quality control and specifications of raw material;

- Manufacturing process of product and standard operating procedures;

- Environmental conditions during the manufacturing process of product;

- Quality control and specifications of finished product. 

c) Comparative Dissolution Profile must be conducted in accordance to ASEAN Guidelines for the Conduct of Bioavailability and Bioequivalence Studies including the calculation of similarity factor (f2) to prove the similarity of these two products.

d) Process validation has been conducted on 3 pilot or commercial batches of the second source product and found satisfactory by the NPRA. 

This exemption is not applicable for any new submission of application for registration of a first source product.  BE study   must be conducted for this product which is manufactured at the actual manufacturing site submitted for registration.

(Reference: Circular Bil.(10)dlm.BPFK/PPP/07/18Jld.1 , 2 Jun 2011)

Sponsors or BE study centers are compulsory to notify the Authority pertaining to all BE studies which do not require Clinical Trial Import Licence (CTIL) or Clinical Trial Exemptions (CTX) and are going to be done at either local or overseas BE study centers for registered products or products to be registered in Malaysia (Directive Arahan di Bawah Peraturan 29, Peraturan-peraturan Kawalan Dadah dan Kosmetik 1984 Bil. 13 Year 2011, 14 October 2011, Bil (23) dlm BPFK/PPP/01/03 Jld 1).

Note: The two above directives shall be read in conjunction with the supplementary circular that further explains the procedure for evaluation of BE centre inspection reports in line with the requirement of accreditation of BE Centres. (Reference: Circular dated 12 September 2013; Bil(6)dlm.BPFK/PPP/01/03 Jld 3.)

Effective 1st March 2013, biowaiver may be granted to generic immediate release oral solid dosage form products containing BCS Class I active ingredients listed in the Guidance On Biopharmaceuticals Classification System (BCS) – Based Biowaiver document. BCS Based biowaivers takes the three major factors that govern the rate and extent of drug absorption from immediate-release solid dosage forms into accounts i.e. solubility and permeability of the drug substance/ API, and dissolution characteristics of the dosage form. This BCS approach provides an opportunity to waive in vivo pharmacokinetic bioequivalence testing for certain categories of immediate-release drug products.

(Directive Arahan di Bawah Peraturan 29, Peraturan-peraturan Kawalan Dadah dan Kosmetik 1984 Bil. 1 Year 2013, 14 October 2011, 28 February 2013, Bil(101)dlm.BPFK/PPP/01/03 Jld 2).

For more information on BE, please refer Information on Bioequivalence.

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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