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 - 药品生产质量管理规范 — 临床试验用药品附录(의약품우수제조관리기준 – 임상시험용의약품 부록) (2022.01 제정)
6. PMDA - 治験薬の製造管理、品質管理等に関する基準（治験薬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 - 药品生产质量管理规范-细胞治疗产品附录 (의약품우수제조관리기준 –세포치료제) (2022.06 제정)
3) CMBA - 嵌合抗原受体修饰T细胞（CAR-T细胞) 制剂制备质量管理规范 (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)