Implementation of Bioequivalence Study Requirement in Malaysia
In line with the Ministry of Health objectives of ensuring quality, efficacy and safety of pharmaceutical products that are marketed, the Drug Control Authority at its 92nd Meeting has decided to review the registration of generic products to include Bioequivalence (BE) studies requirements for certain categories oral immediate release products.
History
The National Working Committee for bioequivalence (BE) study was formed in September 1999. The committee comprised of representatives from University Malaya (UM), Universiti Sains Malaysia (USM), Universiti Kebangsaan Malaysia (UKM), International Medical University (IMU), National Pharmaceutical Regulatory Agency (NPRA) and the pharmaceutical industry. The members were officially appointed to undertake the task of formulating an action plan for the conduct of BE studies in Malaysia through collaborative efforts.
Publication of the 'Malaysian Guidelines for the Conduct of Bioavailability and Bioequivalence Studies' marked the first outcome of this committee's objectives. This guideline is to provide guidance to the local researchers in conducting BE Studies in accordance to established international standards. Implementation of this guideline will promote properly designed studies being carried out.
Objective and Scope
The National Working Committee for Bioequivalence Study was formed with the objective to
- Discuss, BE related issues and to endorse recommendations to these issues based on suggestion by the TWG BE through cooperative effort.
- Establish positions and advocate recommended courses of action to the Drug Control Authority (DCA) on potential emerging issues, and prepare relevant documents regarding the issues of regulatory
The Working Committee's scope includes
- Reviewing national and international requirements related to the conduct of bioequivalence study;
- Identifying active ingredients/ products which require BE studies. This may include to identify and recommend suitable BE comparator products for BE studies in Malaysia.
- Ensuring the conduct or implementation of the BE studies are in accordance to the guidelines and timelines.
- Assisting to publish the DCA approved materials pertaining to BE, when necessary.
