Content and Review of Chemistry, Manufacturing, and Control (CMC) Information for Human Somatic Cell Therapy Investigational New Drug Applications (INDs): Guidance for FDA Reviewers and Sponsors
https://www.fda.gov/media/73624/download
Non classé
WHO GMP for investigational products
https://www.who.int/docs/default-source/medicines/norms-and-standards/current-projects/qas20-863-gmp-for-investigational-products.pdf
EMA Guideline on strategies to identify and mitigate risks for first-in-human and early clinical trials with investigational medicinal products
https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-strategies-identify-mitigate-risks-first-human-early-clinical-trials-investigational_en.pdf
EMA Detailed Commission guidelines on good manufacturing practice for investigational medicinal products for human use, pursuant to the second subparagraph of Article 63(1) of Regulation (EU) No 536/2014
https://health.ec.europa.eu/system/files/2017-12/guideline_adopted_1_en_act_part1_v3_0.pdf
EMA Eudralex Volume 4 Annex 13 – EU Guidelines to Good Manufacturing Practice Medicinal Products for Human and Veterinary Use
https://health.ec.europa.eu/document/download/eb43a2ab-4691-4cab-938e-874f2307dca3_en?filename=2009_06_annex13.pdf
EMA Eudralex Volume 4 Annex 13 – Detailed Commission guidelines on good manufacturing practice for investigational medicinal products for human use, pursuant to the second subparagraph of Article 63(1) of Regulation (EU) No 536/2014
https://health.ec.europa.eu/document/download/a0b206a0-5788-406b-9e20-e0525b16e712_en?filename=guideline_adopted_1_en_act_part1_v3.pdf