SG, Korea signs MRA on medicinal products regulation
The agreement will facilitate trade and access to medicinal products between both countries.
The Health Sciences Authority (HSA) and the Ministry of Food and Drug Safety (MFDS) of Korea signed a mutual recognition agreement (MRA) to establish the requirements of Good Manufacturing Practice (GMP) 1 for medicinal products.
The agreement will enable the mutual recognition of GMP certificates and inspection outcomes of medicine manufacturers from the two countries.
It will reduce duplicative onsite GMP inspections, reducing the regulatory burden on pharmaceutical and biologics manufacturers in both countries.
The MRA will also facilitate trade and access to medicinal products for consumers in both countries
“Signing the MRA will pave the way for timely supply of safer and more effective medicinal products to the public by bilaterally recognising the results of conformity assessment of the two nations based on mutual trust,” Korean Minister Oh Yu-Kyoung said.
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