The Malaysian Drug Control Authority (DCA) has given its approval for the registration of a HIV preventive medicine product under a joint Asean evaluation system, according to the Health Ministry.
Norhaliza A. Halim, the senior director of pharmaceutical services in the ministry, stated that the approval pertains to two HIV-1 preventive medications intended for high-risk groups.
In a statement on Friday (Sept 15), Norhaliza explained, “The DCA has agreed to approve the registration of products through the Asean Joint Assessment (Asean JA) for Apretude 30mg Film-Coated Tablet, which contains Cabotegravir, and Apretude 600mg prolonged-release suspension for injection containing Cabotegravir 600mg.”
She further added, “The approved indications are for preexposure prophylaxis (PrEP) to lower the risk of infections of HIV-1 among the high-risk groups.”
Apretude, manufactured by Glaxo Operations UK Ltd in the United Kingdom, has its product registration held by GlaxoSmithKline Pharmaceutical Sdn. Bhd in Malaysia.
Norhaliza stated that the decision was made during a DCA meeting on Thursday (Sept 14).
She described this as the first time that approvals were granted through the Asean JA pilot project, which also involved the utilization of the Joint Assessment Integrated Management System online platform for the first time.
She said, “This strategic Asean cooperation was established to strengthen the technical capacity of Asean regulatory bodies, which enhances understanding and collaboration among the countries.”
She further explained, “It is an ongoing effort to improve access to medicine among the region’s population to reduce the risk of HIV-1 among the high-risk groups.”
The Asean JA offers a facilitated registration pathway (FRP) where the evaluation of a product is jointly conducted by participating Asean regulatory bodies.
Norhaliza said, “Through this pathway, a company can submit an application simultaneously to the relevant regulatory bodies. The joint evaluation report for the product can then be used for consideration by the respective countries for registration approval.”
She mentioned that the Asean JA will help expedite access to medicine that are of high quality, safe, and effective for Malaysians.
In addition, she stated that the National Pharmaceutical Regulatory Agency (NPRA) will continue to monitor the registered products.
Credit: The Star : News Feed
