EMA GUIDLINE
???????? ?????? ?? ???? guideline ????? ??? ?? EMA
??? ????? ???? ??????? ??????? ?? ?? pharmaceutical industry
??? ?? ?? EMA
?? ?????? EUROPEAN MEDICINE AGENCY
?? ??? ?????? ??? ???? ???? ???? ???? terminology ??? abbreviation
?? legislation ? directives , medicinal product ????? ???? volume ? part , annex , committee ?eudralex
?? ????? ??? ??? ???? ?? terminology ???? ?? guideline ?????? ???? ??? ? refere ?? guide ??
History
?? EMA ???? 1995 ?? ???? ,
?? ??? 2004 ???? ????? European agency for evaluation of medicinal product (EMEA)
????? ????? ??????? ???????? ?? 2019
???? ??????? ????? 27 ???? ??? ???? ??? ??????? ???????
?????? ???? ?? manage ?? EMA ?? ???? ?????? Board of EMA ?????? ?? ??? ???? ???? ?? ?? ???? ?? ??? ??????? ??????? ?? 27 ????
2 ????? ?????? ?? ???????? ???????? ? 2 ?? ???????? ??????? ?????????? ????? ????????? .????? ? 2 ?????? ?? ?????? ???? ??????? ????? ?? ?????? ???? ????? ?? ?????? ??????
??? ?? ?? responsibilities ???? ?? EMA
Protection public and animal health ?? ???? ??? evaluation ?? medicines product ?????? ??? human ??? veterinary
Centralized authorized product procedures ????? ?? ?? ??? ??????? ???? ???? ????? ????? ???? ???? ??? ?? authorization ?? medicinal products ?? ???? ???? ?? ???? ??? ????? application ????? ??
?? ?? regulation ???? ?????
????? ???? ????? ???? ?? ?? EMA ?? ?? Scope ?????? ???? ?? operations of medicinal products for human and veterinary use
???? ???? ?????? ????? ?? ????? ???? ????? ??? pharmaceutical industry ??? ?? EMA ?? ????? ??? ?? ???? ?? ??????? ? ?? public health ??? ?????? ?? ???? ???
?? EMA ???? 7 committee ?? 7 ???? ????? ??? ????? ???? ?????? ?????? ??? ???????? ???????
1. Committee for medicinal products for human use (CHMP )
2.pharmacovigilance risk assessment committee (PRAC)
3.Committee on herbal medicinal product
4.Committee for advanced therapies ( CAT)
5.Committee for medicinal products for veterinary use (CVMP)
6.committee on orphan medicinal products ((COMP)
7.Pediatric Committee (PDCO)
??????? ????6 ??? orphan products ??? ??????? ?????? ???????? ??????? ??? ?? ???? ??? ??????? ?? ??????? ?????? ????? ???? ???? ???
???? ?search ??? google, ????? ???? ?? Committee ?? ?? ???????
???? ????? ????? ??? ??? ?? Eudralex
?? ???? ??? ?? EMA ?????? ???? ?????? ???????? ?????????? ?guidlines ?????? ??? medicinal product
???? ??? ??? ?? ????? ???? ???? ???? ????? ?? ?? legislation ? medicinal productdirectives , volumes
??legislation ??? ????? ????????? ???? ??????? ??????? ??????? ????? ?? ?? EMA ??? ????? ??????? ??? ?? terminology ???? ?? EMA ????? ???? ?? medicinal product ???? ?????? ???? ?? FDA ????? ??? ?? medicinal product ?? drug product ?? ???????? ?? Annual product review APR ?? ????? ?? FDA
???? ?? ?? EMA ????? ???? PQR ?? Product quality review ??? ???? ????? ???? ?????
?? legislation ?? ?????? ?? ?????? ?? ???????? ??????? directives. ?????? ??? ??????? ??? guideline ??????? ???? ??? ?????? ??????? ??? ?? ??? ??guidline ???????? ?????? ???? Directive 2001/83/EC ?? ??? ????? ???? ?? ???????? ?? ?? FDA. ??????? ????? Directive ???? Act ??? ????? ????? ????
???? ??Eudralex ?????? ?? 10 volumes ?? sections ???
?? volume ?? ?????? ??? parts ?? Part 1. ? part 2 ?????
?????? ??? ?? volumes ???? ?????? ?? ?? annexes ?? ???????? ???? ???? ????? ? 21 annex
???? ??? ???? ???????
?? EUDRALEX
????? ??
Legislations
Directives
Volumes
Parts
领英推荐
Annexes
???? ???? ????? ???? ????? ?? Volumes ???? ????? 10
10 volumes
Volume ??? ????? ?? legislation for medicinal products for human use. ?????? ????????
Volume . ?? ????? ?? legislations ???? ??? veterinary use
???? ?? Volumes ??? Guidelines ??? ???? ?????
Volume . Scientific guideline for medicinal product
Volume Good manufacturing practice for medicinal products for human and veterinary use ??? ?? ???? ???? ???? ?????? ????? ?? ????? ?? ??????? ???? ?? EMA
Volume . Notice to applicants and regulatory ???? ??? ?? human ? ?? veterinary
Volume sceintific guidelines for for medicinal product for veterinary use
Volume . ?????? ?? Maximum residue limit ??? ???? ???? ????? ???? ????? cleaning validation ????? ?? MACo ???????? ??
Volume guidelines for pharmacovigilanc
Volume guidelines for clinical trials
???? ??? ????? ?????? ?????? ???? ?????? ?? ?? EUDRALEX VOLUME 4.
GMP guideline ???? ?? EMA
??? ??? ??????? ????? ??
Introduction
??????
part 1. Basic requirement for medicinal product
??? ????? ?? 9 chapters
Chapter 1. Pharmaceutical quality system
Chapter 2. Personnel
Chapter 3. Premise , equipment
Chapter 4 . Documentation
Chapter 5. Production
Chapter 6. Quality control
Chapter 7 outsourced activities
Chapter 8. Complaints and product recall
Chapter 9. Self inspection
Part 2. Basic requirement for active substance used as starting material
Part 3. GMP related document
??? chapter ?? ??? ???? ??? ?? site master file
????? refer ?? Q9 ???? ?? risk management ???? ?? ICH ???? ?????? ????? ???? ???? ????? ???? refere ?? Q10. ?? quality system ???? ?? ICH
???? guide ??? ??? ?? health based exposure limits ???? ???? ???????? ?? ?? risk identification ??????? ???? ????? cleaning validation
Part 4. GMP requirement for advanced therapy medicinal product
?? ??? ?? annexes ??? parts
???? ?? Annex 1 ??? Annex 21
Annex 18,20 replaced by ICH Q9.
?????
Annex 1. ??? manufacture of medicinal sterile product
Annex 8. Sampling of starting and packaging materials
Annex 9. Manufacturing of liquids ,creams and ointments
Annex 11. Computerized system
Annex 15. Qualifications and validation b
Annex 16. Certification by aqualified person and batch release
??? ??? ???????