South Korea Agrees to Numerous Arrangements with European Counterparts

Country: FRANCESOUTH KOREASWITZERLAND | Region: ASIA & SOUTH PACIFICEUROPE | Type: Regulation | Keywords: #ansm #drugapproval #europeandirectorate #gmpinspection #swissmedic

PRICENTRIC BRIEF:

  • The Ministry of Food and Drug Safety agreed to a joint trust arrangement for good manufacturing practice (GMP) with the Swiss Agency for Therapeutic Products, Swissmedic, a deal that will lessen the drug approval procedure for local biopharmaceutical firms by excusing them from Swiss GMP assessment
  • Moreover, South Korea believes this deal affirms that its regulatory capacity and pharmaceutical sector are on par with Switzerland, as well as other A7 nations, including the United Kingdom, Italy, Japan, Germany, France, and the United States
  • South Korea also signed a memorandum of understanding with France’s National Agency of Medicine and Health Products Safety (ANSM) and the European Directorate for the Quality of Medicines and HealthCare that would allow all parties to exchange private data, for example, drug review, evaluation scores, and regulatory data

THE DETAILS

SEOUL, South Korea – The Ministry of Food and Drug Safety agreed to a joint trust arrangement for good manufacturing practice (GMP) with the Swiss Agency for Therapeutic Products, Swissmedic.

The contract between South Korea and Switzerland implies that a GMP certification granted by Swissmedic or South Korea can excuse firms from additional valuation when progressing into either country.

South Korea hopes that the deal will lessen the drug approval procedure for local biopharmaceutical firms because it excuses them from Swiss GMP assessment.

Moreover, South Korea believes this deal affirms that its regulatory capacity and pharmaceutical sector are on par with Switzerland, as well as other A7 nations, including the United Kingdom, Italy, Japan, Germany, France, and the United States.

South Korea also signed a memorandum of understanding with France’s National Agency of Medicine and Health Products Safety (ANSM) and the European Directorate for the Quality of Medicines and HealthCare that would allow all parties to exchange private data, for example, drug review, evaluation scores, and regulatory data.

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