PETALING JAYA: The mutual recognition of drug approvals among Asean members is now easier with the Asean Joint Assessment (Asean JA) pilot project, says the Health Ministry.
The ministry’s pharmaceutical services senior director Norhaliza A. Halim said the Malaysian Drug Control Authority (DCA) had approved, for the first time, the registration of an HIV preventive medicine through the Asean JA evaluation system.“This strategic Asean cooperation was created to empower the technical capacity of Asean regulatory bodies that enhance understanding and collaboration among member countries.
“It is an ongoing effort to enhance access to medicine among the region’s population to reduce the risk of HIV-1 among high-risk groups,” Norhaliza said in a statement yesterday.
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.
Norhaliza said the approvals also marked the first time that they were done using the Joint Assessment Integrated Management System online platform.
She said the Asean JA will help speed up access to medicine which are of high quality, safe and effective for Malaysians.
Norhaliza added that the National Pharmaceutical Regulatory Agency (NPRA) will continue to monitor products that have been registered.
She said the DCA had approved the use of two HIV-1 preventive medications for those in high-risk groups.
The approvals were for the Apretude 30mg Film-Coated Tablet, which contains Cabotegravir, as well as Apretude 600mg prolonged-release suspension for injection containing Cabotegravir 600mg.
“The approved indications are for pre-exposure prophylaxis (PrEP) to lower the risk of infections of HIV-1 among high-risk groups,” she added.
