ICH guideline Q13 on continuous manufacturing of drug substances and drug products
This guideline describes scientific and regulatory considerations for the development, implementation, operation, and lifecycle management of continuous manufacturing (CM). Building on existing ICH Quality guidelines, this guideline provides clarification on CM concepts, describes scientific approaches, and presents regulatory considerations specific to CM of drug substances and drug products.
This guideline applies to CM of drug substances and drug products for chemical entities and therapeutic proteins. The principles described in this guideline may also apply to other biological/biotechnological entities.
It is applicable to CM for new products (e.g., new drugs, generic drugs, biosimilars) and the conversion of batch manufacturing to CM for existing products.
Consultation dates: 29/07/2021 to 20/12/2021
Open Consultation file (Click here)
Guideline on core SmPC, Labelling and Package Leaflet for advanced therapy medicinal products (ATMPs) containing genetically modified cells.
This guideline describes the information to be included in the summary of products characteristics (SmPC), labelling and package leaflet for advanced therapy medicinal products (ATMPs) containing genetically modified cells. This applies to allogeneic or autologous, including viral vector modified and genome edited cells.
Consultation dates: 30/07/2021 to 31/10/2021
Open Consultation file (Click here)