임상시험용의약품 GMP 정보집

Ⅰ. 개요
1. 배경
2. 임상시험용의약품 GMP 관련 지침
3. 특정 제제별 임상시험용의약품 고려사항

Ⅱ. 임상시험용의약품 GMP 관련 지침
1. PIC/s - Guide to GMP for medicinal products Annex 13. Manufacture of IMPs
(2022.02 개정)
2. PIC/s - Guide to GMP for medicinal products Annex 2A. Manufacture of ATMPs for
Human Use (2021.05 개정)
3. FDA - CGMP for phase 1 investigational Drugs (2008.07 제정)
4. EMA - Guidelines on GMP specific to ATMP (2017.11 제정)
5. NMPA - ?品生??量管理?范 - ?床??用?品附?(의약품우수제조관리기준 - 임상시험용의약품 부록) (2022.01 제정)
6. PMDA - 治??の製造管理、品質管理等に?する基準（治??ＧＭＰ）について
(시험약의 제조관리, 품질관리에 대한 기준 (시험약 GMP)) (2008.07 제정)
7. Health Canada - Guidance Document Annex 13. GMP Guidelines Drugs Used in Clinical
Trials (2009.12 제정)

Ⅲ. 특정 제제별 임상시험용의약품 고려사항
1. mRNA 백신
1) WHO - Evaluation of the quality, safety and efficacy of mRNA vaccines for the
prevention of infectious : regulatory considerations (2021.12 제정)
2. 생균치료제
1) FDA - Early clinical trials with LBP : CMC information (2016.06 제정)
2) EMA - European Pharmacopoeia 3053 - Live Biotherapeutic Products for Human Use (2019.04 제정)
3. CAR-T
1) FDA - Considerations development CAR-T Cell Products (2022.03 제정)
2) NMPA - ?品生??量管理?范-?胞治??品附? (의약품우수제조관리기준 -세포치료제) (2022.06 제정)
3) CMBA - 嵌合抗原受?修?T?胞（CAR-T?胞) 制?制??量管理?范 (중국 생명공학 협회 -CAR-T 세포 의약품 우수제조관리기준) (2018.04 제정)
4. 진단용 방사성의약품
1) IAEA/WHO - Guideline on GMP for investigational radiopharmaceutical products (2021.07 제정)
2) EMA -Guidelines to GMP medicinal products for human and veterinary use Annex 3. Manufacture of Radiopharmaceuticals (2008.09 제정)

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