15-9-2023 (KUALA LUMPUR) The Malaysian Drug Control Authority (DCA) has granted approval for the registration of a groundbreaking HIV preventive medicine product, marking the first time it has been authorized under a joint evaluation system by the Association of Southeast Asian Nations (ASEAN), according to the Health Ministry.
Norhaliza A. Halim, the senior director of pharmaceutical services at the ministry, stated that the DCA has agreed to register two HIV-1 preventive medications targeting high-risk groups through the ASEAN Joint Assessment (ASEAN JA). The approved products are Apretude 30mg Film-Coated Tablet, containing Cabotegravir, and Apretude 600mg prolonged-release suspension for injection, which also contains Cabotegravir 600mg.
“The approved indications are for preexposure prophylaxis (PrEP) to lower the risk of HIV-1 infections among high-risk groups,” Norhaliza said in a statement released on Friday (Sept 15).
Apretude is manufactured by Glaxo Operations UK Ltd in the United Kingdom, with the product registration in Malaysia held by GlaxoSmithKline Pharmaceutical Sdn. Bhd.
Norhaliza stated that the decision was made during a DCA meeting on Thursday (Sept 14) and highlighted that this was the first time approvals were granted through the ASEAN JA pilot project, which also utilized the Joint Assessment Integrated Management System online platform for the first time.
“This strategic ASEAN cooperation aims to strengthen the technical capacity of ASEAN regulatory bodies and promote understanding and collaboration among member countries. It is an ongoing effort to improve access to medicine for the region’s population and reduce the risk of HIV-1 among high-risk groups,” she further explained.
The ASEAN JA provides a facilitated registration pathway (FRP) where the evaluation of a product is jointly conducted by participating regulatory bodies within ASEAN.
“Through this pathway, a company can simultaneously submit an application to the relevant regulatory bodies. The joint evaluation report can then be considered by the respective countries for registration approval,” Norhaliza added.
She emphasized that the ASEAN JA will expedite access to high-quality, safe, and effective medicines for Malaysians. Additionally, the National Pharmaceutical Regulatory Agency (NPRA) will continue to monitor the registered products.
