Overview of regulatory frameworks on the national lot release of plasma-derived medicinal products in Korea

Author:

Seong Su KyoungORCID,Kim Young Hoon,Choi Youngju,Koh Hyun Jung,Kim Seong Jae,Kim Myoung Jun,Choi Chan WoongORCID

Funder

Ministry of Food and Drug Safety

Publisher

Elsevier BV

Reference15 articles.

1. Supply and demand for plasma‐derived medicinal products – a critical reassessment amid the COVID‐19 pandemic;Hartmann;Transfusion,2020

2. Report on the seventh meeting of national control laboratories for vaccines and biologicals of the WHO Western Pacific and South-East Asia member states;Shim;Biologicals,2023

3. Guidelines for independent lot release of vaccines by regulatory authorities;World Health Organ Tech Rep S,2013

4. Regulation on the designation, approval procedure, and method of biological products subject to national lot release, etc;MFDS notification,2023

5. Minimum requirements for biological products;MFDS notification, No. 2022–58,2022

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