MHRA releases spate of new guidelines on decentralized manufacturing
Regulatory NewsJoanne S. Eglovitch
Advanced manufacturingAdvanced therapies/cell and gene therapyApproval/marketing authorizationChemistry, Manufacturing and Controls (CMC)Decentralized clinical trialsDrug master file (DMF)EuropeGCPGMPHuman cells, tissues, and cellular and tissue-based products (HCT/Ps)ManufacturingPharmaceuticalsPharmacovigilanceProduct developmentRegulatory Intelligence/PolicyRisk management