Regulatory agency expands cooperation with European counterparts

Korea Biomedical Review

18 december 2019 - The Ministry of Food and Drug Safety said that it has signed multiple agreements with its counterparts in the EU to strengthen cooperation in the pharmaceutical sector.

For instance, the ministry signed a mutual trust agreement for the pharmaceutical good manufacturing practice (GMP) sector with Swiss Agency for Therapeutic Products (Swissmedic), while signing a memorandum of understanding to exchange confidential information with the France's National Agency of Medicine and Health Products Safety (ASNM) and European Directorate for the Quality of Medicines and HealthCare (EDQM).

The ministry said it expects the agreement will drastically reduce the drug approval process for local biopharmaceutical companies because it will exempt them from the GMP evaluation of Swissmedic.

The regulator agency stressed that the accord confirms that Korea's GMP system and management level is equivalent to that of Switzerland.

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Michael Wonder

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Michael Wonder