Singapore’s Health Sciences Authority (HSA) and Malaysia’s National Pharmaceutical Control Bureau (NPCB)—the pharmaceutical regulatory body within the Malay Ministry of Health (MOH)—recently signed a memorandum of understanding (MOU) on pharmaceutical regulatory matters. This is the first health sector MOU signed by the Malay MOH.
The two national drug regulatory agencies have cooperated before through the ASEAN Pharmaceutical Product Working Group. This MOU formalizes Singapore and Malaysia’s joint efforts toward greater harmonization of pharmaceutical regulations in their respective countries.
The MOU will promote greater sharing of information between the two regulatory agencies. The HSA and the MOH hope to exchange assessment reports on pharmaceutical product registrations, as well as audits on the quality of active pharmaceutical ingredients and finished dosage drugs. The two pharmaceutical regulatory agencies also anticipate the establishment of a joint system of post-market surveillance and enforcement for drug products. All these efforts will allow the HSA and Malaysia’s MOH to better promote public health and safety in their respective countries.
Through the MOU, Singapore and Malaysia will be able to combine their resources and better respond to regulatory issues and challenges. The collaboration efforts will also facilitate market entry of pharmaceutical drugs in Singapore and Malaysia. Due to the joint evaluations and audits, foreign drug companies looking to register their products in the Singaporean and Malaysian markets should face less time and costs.