The National Institute of Food and Drug Safety Evaluation has announced a rationalization of stability test data requirements for pharmaceutical manufacturing method changes, aligning them with international standards set by the World Health Organization and the European Union. This regulatory update strengthens the emphasis on test data, product quality, and compliance with global guidelines. The revision reduces the required stability test data submission period from six months to three months, improving efficiency while maintaining high standards of safety and product quality. This change also reflects the pharmaceutical industry's need for streamlined processes that uphold robust quality management. As a result, the updated requirements are expected to enhance the stability and resilience of the domestic pharmaceutical supply, ensuring timely availability of safe and effective medicines without compromising regulatory rigor.

The document covers the following key points:

  • The Ministry of Food and Drug Safety is accepting applications for changes in manufacturing methods of approved drugs to harmonize with international standards.
  • The revision of stability test data requirements responds to industry requests for improved efficiency and stronger product quality controls.
  • This regulatory improvement is expected to reinforce the stability of the domestic pharmaceutical supply by reducing data preparation and approval timelines.

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https://www.mfds.go.kr/brd/m_99/view.do?seq=49456&srchFr=&srchTo=&srchWord=&src…
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