ѱ̿Ǿǰȸ ȳ帳ϴ.
ǰǾǰó 躸DZⱸ(WHO) ̿Ǿǰ ǥȭ о ¼ͷμ ̵ . ϰ , 躸DZⱸ(WHO) Ʒ Ǿǰ ̵ . Դϴ.
- -
. WHO Pilot procedure for prequalification of similar biotherapeutic products.
. WHO Guidelines on submission of documentation for the pilot procedure for prequalification of similar biotherapeutic products approved by stringent regulatory authorties.
. WHO Guidelines on submission of documentation for the pilot procedure for prequalification of similar biotherapeutic products.
. Guidelines on procedures and data requirements for changes to approved biotherapeutic products.
~ ̵() Ͽ ǰ ִ Ŀ ǰ ۼϿ 2017.08.07() ȸ Ͽ ֽñ ٶϴ.
( , , ̵() : 4 ǰ , ̵() : 6 ǰ )
[÷] 1. 1. . WHO Pilot procedure for prequalification of similar biotherapeutic products
2. 2. . WHO Guidelines on submission of documentation for the pilot procedure for prequalification of similar biotherapeutic products approved by stringent regulatory authorities
3. 3. . WHO Guidelines on submission of documentation for the pilot procedure for prequalification of similar biotherapeutic products
4. 4. Submission_of_comments (~ٿ ǰ )
5. 5. . BS2311 Guidelines on procedures and data requirements for changes to approved biotherapeutic products
6. 6. Comment_Form ( ǰ )