Asas Regulatori
NPRA was given the task of ensuring the quality, efficacy and safety of pharmaceuticals through the registration and licensing scheme. This is achieved through evaluation of scientific data and laboratory tests on all products before they are marketed. A system to monitor products in the market was set-up. Information on drugs to medical profession and consumer was made available through a drug information service.
1.0 Product Classification
It is important to determine the category of a product that falls within the food-drug interphase (FDI) whether the products are regulated as drug (health supplement or natural product under the NPRA’s purview) or, as food (under the FSQ’s purview) because different regulatory requirements apply. Therefore, the following flowchart serves only as guide to help you determine the category of the product that falls within the FDI
- Product Classification Guideline
- Product Classification Application Manual (NPRA 300.1)
- Product Classification Form (PDF)
- Product Classification Form (Ms Word)
2.0 QUEST3+ System Basic
The QUEST 3+ system has been fully utilized from January 2017 for the purpose of registration of medicines and cosmetics and licensing products in Malaysia. As of December 19, 2017, 23,817 drug products and 178,809 cosmetic products have been registered in Malaysia in QUEST 3+.
- Register USB Token
- Token & Java Configuration
- Example of Letter of Authorization for Membership Registration
- Payment Using Personal Account - B2C
- Payment Using Corporate Account - B2B
- Payment Using Credit Card
- User Manual for QUEST Module
- Internet Browser Configuration
- FAQ - MEMBERSHIP & TOKEN
- FAQ - QUEST ONLINE PAYMENT
3.0 ASEAN Guidance Documents
ASEAN Registration of Pharmaceuticals for Human Use
(The following were abstracted from the Health Sciences Authority Singapore site)
ASEAN Common Technical Dossier (ACTD)
- Organisation 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
ASEAN Common Technical Requirements (ACTR)
- 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 Sterilised Products
- Annex B Table of Content of Process Validation Documentation
- Annex D Glossary
- ASEAN Guidelines for Validation of Analytical Procedures
- 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)
- ASEAN Guidelines for the Conduct of Bioavailability and Bioequivalence Studies
- ASEAN Guideline on Process Validation Q&A
4.0 Guideline For The Submission Of Product Samples For Laboratory Testing
The submission of sample for laboratory testing is as part of the registration process. This guideline consists of the general and specific requirements for the submission of samples to the Centre for Quality Control for laboratory testing. The general requirements define the condition of the samples to be submitted whereas the specific requirements illustrate the additional details needed according to the category of product.
The applicant is given a period of 14 working days from the date of screening approval to send samples for laboratory testing. If the samples are not submitted within the specified time frame, the application will be rejected.
The applicants shall comply with these requirements and failure to meet any of these requirements may cause rejection of the samples.
- Guideline For The Submission Of Product Samples For Laboratory Testing
5.0 Clinical Trials
Clinical trial is an expanding area of clinical research in Malaysia, and with the increasing complexity of clinical trials conducted in the country, it is essential to review current standards for compliance with international clinical trial standards and guidelines.
The primary purpose of the Malaysian Guideline for Good Clinical Practice (GCP) is to provide researchers, reviewers, sponsors and regulators of clinical trials a description of the fundamental principles and requirements that ensure regulatory compliance. The Malaysian GCP follows the same basic structure and format of the International Council for Harmonisation (ICH) E6 Good Clinical practice Guideline.
Since the introduction of the first edition of the Malaysian GCP in 1999, more than 12,000 healthcare professionals and researchers have been GCP-trained and certified.