PUTRAJAYA, Nov 5 — Updates to the Guideline For Facilitated Registration Pathway (GFRP), to be effective from Jan 1, were approved during the meeting of the Drug Control Authority (PBKD) on Nov 3, as part of efforts to strengthen the Facilitated Registration Pathway (FRP).
Heath director-general Datuk Dr Muhammad Radzi Abu Hassan said among the aspects updated in the GFRP are the expansion of the product scope to include generic drugs, in addition to new drugs and biologics, the addition of the number of reference regulatory agencies from two to seven and an approach to joint assessment among Asean countries (Asean Joint Assessment).
He said the meeting approved the registration of the product Ocrevus (ocrelizumab) 300mg/10ml Concentrate for Solution for Infusion for the treatment of multiple sclerosis through a joint assessment of Asean countries, and the product was successfully registered within 30 working days as outlined in the latest GFRP.
“With the initial achievement of FRP and the Asean Joint Assessment, the Health Ministry (MoH), through the National Pharmaceutical Regulatory Agency (NPRA), is committed to continuing efforts to improve the regulatory system to enhance Malaysians' access to quality, safe and effective medicines.”
Dr Muhammad Radzi said the NPRA is continually striving to enhance the efficiency of the regulatory system to improve patients' access to new drug products, and one alternative route for drug product registration in Malaysia is the FRP introduced by the NPRA in 2019.
Through the FRP, he said the scientific assessment of new drugs is carried out using a reliance approach, which involves referring to assessment reports of regulatory bodies in other countries such as the European Medicines Agency (EMA) and the United States Food and Drug Administration (USFDA).
He added that the reliance approach aligns with the World Health Organisation's recommendations to reduce work duplication among regulatory bodies and improve the efficiency of new drug assessment processes.
— Bernama
