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Regulatory agency expands cooperation with European counterparts
  • By Lee Han-soo
  • Published 2019.12.18 11:22
  • Updated 2019.12.18 11:22
  • comments 0

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 agreement between MFDS and Switzerland is designed to recognize the results of the GMP fact-finding survey conducted by each other," the ministry said. "This means that a GMP certification issued by either the MFDS or Swissmedic can exempt companies from further assessment when advancing into the respective countries."

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.

"As Switzerland is one of the advanced pharmaceutical powers of A7 countries – U.S., U.K., France, Germany, Italy, Switzerland, and Japan – it proves that the local regulatory capacity and pharmaceutical industry is similar to that of advanced countries," the ministry said.

Regarding the contract with the French and EU regulators, the ministry noted that the agreement would allow them to exchange confidential information, such as regulatory information, drug review, and evaluation information, with its counterparts.

The ministry said the cooperation would strengthen local drug safety management by promptly responding to risk information such as drug quality issues.

"We expect the cooperation with the European regulators will help us promptly respond to drug risk information and preemptively manage drug safety," a ministry official said. "The accords will also contribute to the advancement of Korean medicines overseas as they have increased the reliability of Korea's regulation of pharmaceuticals."


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