Putrajaya: Malaysia Enhances Drug Regulatory Framework with Updated GFRP

In Putrajaya, significant updates to the Guideline for Facilitated Registration Pathway (GFRP), set to take effect from January 1, were approved at the November 3 meeting of the Drug Control Authority (PBKD). These updates are part of ongoing efforts to bolster the Facilitated Registration Pathway (FRP) for drugs in Malaysia.

According to BERNAMA News Agency, the revisions in the GFRP include broadening the product scope to encompass generic drugs, in addition to new drugs and biologics. The update also increases the number of reference regulatory agencies from two to seven and introduces an approach for joint assessments among ASEAN countries, known as the ASEAN Joint Assessment.

Dr. Muhammad Radzi highlighted the recent approval of Ocrevus (ocrelizumab) 300mg/10ml Concentrate for Solution for Infusion, a treatment for multiple sclerosis. This product was registered through the ASEAN Joint Assessment and successfully met the 30-working-day registration target under the new GFRP guidelines.

The Health Ministry, through the National Pharmaceutical Regulatory Agency (NPRA), reaffirms its commitment to enhancing the regulatory system. This improvement aims to provide Malaysians with better access to quality, safe, and effective medicines. The NPRA, since introducing the FRP in 2019, has been continuously working to boost the efficiency of the regulatory system, facilitating swifter access for patients to new drug products.

Under the FRP, the NPRA employs a reliance approach for the scientific assessment of new drugs. This method involves referencing assessment reports from regulatory bodies in other countries, such as the European Medicines Agency (EMA) and the United States Food and Drug Administration (USFDA). This approach is in line with the World Health Organisation’s recommendations to minimize duplication of work and enhance the efficiency of new drug assessment processes among regulatory bodies.