PUTRAJAYA, 15 Sept — The registration of products assessed by the Association of Southeast Asian Nations Joint Assessment (Asean JA) process has been approved for the very first time during the 388th Drug Control Authority (DCA) of Malaysia meeting on Sept 14.
Asean JA is a facilitated registration pathway (FRP) where the assessment of a product is conducted jointly by regulatory bodies of participating Asean countries.
Health Ministry Pharmacy Services senior director Norhaliza A Halim said companies can now submit their registration applications to all regulatory bodies simultaneously using the FRP.
“The jointly generated product assessment report would be used for registration approvals in their own countries,” she said in a statement today, adding that Apretude 30mg Film-Coated Tablet (containing Cabotegravir 30mg) and Apretude 600mg Prolonged-release suspension for injection (containing Cabotegravir 600mg) were approved during the meeting.
Apretude products are manufactured by Glaxo Operations UK Ltd, and its product registration in Malaysia is held by GlaxoSmithKline Pharmaceutical Sdn Bhd.
Norhaliza said the approval is for pre-exposure prophylaxis (PrEP) to reduce the risk of human immunodeficiency virus-1 (HIV-1) infection among at-risk groups. The Philippines spearheaded the Asean JA evaluation for products containing the active ingredient cabotegravir, with participation from Malaysia, Myanmar, Thailand, and Vietnam.
The assessment was also a pilot study of Asean JA using an online platform called the Joint Assessment Integrated Management System, and the strategic partnership aims to boost the technical abilities of Asean regulatory bodies and improve understanding and collaboration among countries to enhance access to medicines in the region, she added.
Product registrations via the Asean JA is an initiative by Health Ministry in its continuous effort to enhance and expedite Malaysians’ access to quality, safe, and effective medicines, she shared.
— Bernama
