PETALING JAYA: The Malaysian Drug Control Authority (DCA) has approved for the first time the registration of a HIV preventive medicine product under a joint Asean evaluation system, says the Health Ministry.
The ministry's pharmaceutical services senior director Norhaliza A. Halim said that the approval was in respect of two HIV-1 preventive medications for those in high risk groups.
"The DCA 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.
"The approved indications are for preexposure prophylaxis (PrEP) to lower the risk of infections of HIV-1 among the high risk groups," she said in a statement on Friday (Sept 15).
Apretude is manufactured by Glaxo Operations UK Ltd in the United Kingdom with GlaxoSmithKline Pharmaceutical Sdn. Bhd holding the product registration in Malaysia.
Norhaliza said the decision was reached at a DCA meeting on Thursday (Sept 14).
She said it marked the first time that approvals were done through the Asean JA pilot project which also included the use of the Joint Assessment Integrated Management System online platform for the first time.
"This strategic Asean cooperation was created to empower the technical capacity of Asean regulatory bodies which enhance understanding and collaboration among the countries.
"It is an ongoing effort to enhance access to medicine among the region's population to reduce the risk of HIV-1 among the high risk groups," she added.
The Asean JA, she said, provides a facilitated registration pathway (FRP) where evaluation of a product is done jointly by participating Asean regulatory bodies.
"Through the pathway, an application can be submitted by a company simultaneously to the regulatory bodies concerned.
"The joint evaluation report for the product can then be used for consideration by the respective countries for registration approval," she added.
She said that the Asean JA would help speed up access to medicine which are of quality, safe and effective for Malaysians.
She added that the National Pharmaceutical Regulatory Agency (NPRA) will continue to monitor products which have been registered.
