GMP certificates and/or inspection outcomes of medicine manufacturers in Singapore and South Korea are mutually recognized and accepted by MFDS and HSA, respectively.

Singapore's Health Sciences Authority (HSA) has announced the signature of a GMP Mutual Recognition Agreement (MRA) with South Korea's Ministry of Food and Drug Safety (MFDS).

1. The MRA will enable the mutual recognition of GMP certificates and inspection outcomes of medicine manufacturers in Singapore and South Korea.
2. The key benefit is the reduction of regulatory burden on the pharmaceutical and biologics manufacturers through reducing duplicative onsite GMP inspections by both regulatory agencies. It improves efficiency by cutting down the resources needed to assess manufacturing sites. This will facilitate trade and access to medicinal products for consumers in both countries.
3. The areas of cooperation between HSA and MFDS will include the following:
   1. Mutual recognition of each other’s GMP certificates for the manufacture of investigational medicinal products, active pharmaceutical ingredients, chemical pharmaceuticals, biopharmaceuticals (including biologicals) or herbal medicinal products.
   2. At the request of an importer, exporter, or authority (HSA or MFDS), the other authority is able to assess and certify that a manufacturer:
   3. is appropriately authorised to manufacture the specified medicinal products or carry out the specified manufacturing operation;
   4. is subject to regular inspections by the authority of the territory; and
   5. complies with the Pharmaceutical Inspection Co-operation Scheme (PIC/S)[2] GMP standard.
   6. Exchange of information on GMP compliance (e.g., inspection reports).

Either authority may request the right to conduct its own inspections of manufacturing sites located in the territory of the other authority in exceptional circumstances for the purpose of health and safety.

Source: HSA announcement.