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Swiss and Korean regulators agree to mutually recognize GMP inspections

2020/01/13  RAPS

Swissmedic and South Korea’s Ministry of Food and Drug Safety (MFDS) agreed last month to mutually rely on each other’s good manufacturing practice (GMP) inspection results for medicinal products.

The agreement is designed to help with the trade in medicinal products between the two countries and reduce the workload of the regulators authorizing and monitoring medicinal products. In addition to mutual reliance, the agreement will allow for the sharing of other information, documents and inspection reports.

“In a constantly evolving regulatory environment, and given the increasingly complex requirements pertaining to therapeutic product development and production, international collaboration is vital for staying on top of the growing challenges,” Swissmedic said in a statement.

Raimund Bruhin, director of Swissmedic, and Eui Kyung Lee, minister of MFDS, signed the agreement in Bern, Switzerland.

Meanwhile, last February, as part of a mutual recognition agreement between the EU and Switzerland, Swissmedic began entering GMP compliance and manufacturing authorizations into the EU’s EudraGMDP database.

And previously in 2018, Netherland’s Medicines Evaluation Board (MEB) and Swissmedic signed a memorandum of understanding (MOU) allowing for greater collaboration, while in 2016, UK’s Medicines and Healthcare products Regulatory Agency and Swissmedic also signed an MOU.

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