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.
Apretude is manufactured by Glaxo Operations UK Ltd in the United Kingdom with GlaxoSmithKline Pharmaceutical Sdn. Bhd holding the product registration in Malaysia.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.
The Asean JA, she said, provides a facilitated registration pathway where evaluation of a product is done jointly by participating Asean regulatory bodies.
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