Regulation Basics

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

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+.

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. 

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.

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

DISCLAIMER

The Government of Malaysia and the National Pharmaceutical Regulatory Agency are not responsible for any loss or damage caused by the usage of any information obtained from this website.

Mobile Web :

Newsletter Subsription

Site Last Modified

  • Last Modified: Friday 14 December 2018, 08:46:08.
© Copyright 2018 . All Rights Reserved National Pharmaceutical Regulatory Agency NPRA