Regulation (EU) 2017/745 on medical devices (MDR) contains different legal provisions that allow Member States to determine language requirements for manufacturers at national level for information accompanying the device. The following table gives an overview...
This draft guidance, within the context of FDA approval and license decisions, describes the use of alternative tools to assess manufacturing facilities identified in an NDA, an ANDA, or a BLA to establish that these...
The EMA has announced a public webinar taking place on 15th September 2023 for pharmaceutical industry companies interested in learning more about the Regulatory Procedures for medicinal products onboarding on IRIS. The onboarding of regulatory procedures...
The collaborators will use automated and digital technologies to improve the process of manufacturing adeno-associated viruses (AAV). London, Stevenage, Wednesday 23 August 2023: The Cell and Gene Therapy Catapult (CGT Catapult), an independent innovation and technology...
The collaborators have been awarded £800,000 of Innovate UK Biomedical Catalyst funding to develop an integrated and scalable platform to manufacture allogeneic induced pluripotent stem cell (iPSC) derived immunotherapies. The project consortium is led by Plasticell,...
The FDA has published general instructions for the completion of Biological Product Deviation Report (BPDR). The FDA requires reporting of certain deviations and unexpected events in manufacturing in accordance with 21 CFR 600.14, 606.171 or...
Manufacturing and control of CGT products can often be affected by unique factors such as limited knowledge of product quality attributes, limited manufacturing experience, limited variable starting materials, limited amount of product, complex manufacturing processes,...
EDQM has announced that the CEP 2.0 will be implemented on 1 September 2023. From that date onwards, new dossier applications and renewal applications will receive a CEP 2.0, whereas revision applications will receive a...
Seventeen new projects will receive funding for cutting edge medicine manufacturing, delivered by the Innovate UK Transforming Medicine Manufacturing programme. Today, Innovate UK, the UK’s innovation agency, is pleased to announce the winners of a...
Swissmedic has published a new “Guidance document GMP compliance by foreign manufacturers” and a form “Declaration by the Responsible Person for foreign manufacturers” with the aim of clarifying the conditions for the submission of an...
