MFDS Strengthens Information Sharing on Pharmaceutical Manufacturing and Quality Control with Europe

Revision of the 'Guidelines for Notification of Administrative Disposition Information on Active Pharmaceutical Ingredients to the EU'

[Asia Economy Reporter Kim Ji-hee] The Ministry of Food and Drug Safety announced on the 3rd that it will strengthen information sharing with the European Union (EU) regarding the manufacturing and quality management of active pharmaceutical ingredients used in drug production.

Korea was recognized as having an equivalent level of the EU's "Good Manufacturing Practice (GMP)" for pharmaceuticals and was listed on the "EU Whitelist" in May 2019. The EU Whitelist exempts countries from submitting GMP certificates when exporting active pharmaceutical ingredients to the EU. Currently, seven countries including Korea, Switzerland, Australia, Japan, the United States, Israel, and Brazil are listed.

Following its inclusion on the EU Whitelist, the Ministry of Food and Drug Safety established the "Guidelines for Notifying the EU of Administrative Actions on Active Pharmaceutical Ingredients" in 2019 to provide information on domestic GMP violations related to active pharmaceutical ingredients to the EU.

In particular, due to restrictions on on-site GMP inspections between countries caused by the recent global COVID-19 pandemic, the Ministry revised the guidelines to enable more systematic management of the history of administrative actions and other information related to the manufacturing and quality management of active pharmaceutical ingredients notified to the EU. Additionally, the scope of information provided was expanded to include details such as the location of the manufacturing site, GMP violations, and domestic measures like product recalls, thereby offering clearer and broader information.

The Ministry of Food and Drug Safety stated, "Through this revision, we aim to solidify our status as an EU Whitelist country and actively cooperate with European countries in the pharmaceutical GMP field, which we expect will greatly assist Korean pharmaceutical companies in entering the European market."

This content was produced with the assistance of AI translation services.