Asean harmonises drug approvals

The Health Ministry announced that the Asean Joint Assessment (Asean JA) pilot project is simplifying the mutual recognition of drug approvals among Asean members. Norhaliza A. Halim, the senior director of pharmaceutical services in the ministry, stated that the Malaysian Drug Control Authority (DCA) has granted approval for the registration of an HIV preventive medicine through the Asean JA evaluation system. The Asean JA aims to strengthen the technical capacity of Asean regulatory bodies and promote collaboration among member countries. It is an ongoing initiative to improve access to medicine and reduce the risk of HIV-1 among high-risk groups in the region.

Norhaliza explained that the Asean JA offers a facilitated registration pathway (FRP) where the evaluation of a product is carried out jointly by participating Asean regulatory bodies. This pathway allows companies to submit applications simultaneously to the relevant regulatory bodies. The joint evaluation report can then be used by the respective countries to consider the approval for registration.

Norhaliza also highlighted that the drug approvals were the first to be done using the Joint Assessment Integrated Management System online platform. She emphasized that the Asean JA will expedite access to high-quality, safe, and effective medicines for the Malaysian population. The National Pharmaceutical Regulatory Agency (NPRA) will continue to monitor the registered products.

The DCA has approved two HIV-1 preventive medications for high-risk groups. The first one is Apretude 30mg Film-Coated Tablet, which contains Cabotegravir, and the second one is Apretude 600mg prolonged-release suspension for injection containing Cabotegravir 600mg. These medications are indicated for pre-exposure prophylaxis (PrEP) to reduce the risk of HIV-1 infections among high-risk groups.