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South Korea issued a notice of materials application for pre-review of GMF safety review in 2022

MFDS 韩国食品药品安全部EN
On July 18, the Ministry of Food and Drug Safety (MFDS) of South Korea issued the "Notification of materials application for pre-review of GMF safety review in 2022" in order to effectively conduct safety review of GMF.
 
Applicants : applicants (developers and agents) with no experience in safety review application, and enterprises planning to apply for research and development of new protein products.
 
Pre-review contents: product characteristics data, whether the materials are prepared for each review project, whether the submitted materials are appropriate, the preparation of application materials, abstracts and other materials and the introduction of submission methods.
 
Application time: July 18, 2022 to July 29, 2022.
 
Consultation date: expected September 27, 2022.


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