MHRA is inviting members of the public, including the patients, medical device researchers, developers, manufacturers and suppliers, clinicians, other healthcare professionals to provide their views on the introduction of common specification requirements to the regulatory...
UKRI is backing 21 cross-sector collaborations designed to spark innovation, commercialisation and growth in UK sustainable biomanufacturing. When it comes to manufacturing, the UK is one of the biggest players on the world stage. Spanning...
The FDA has reiterated its plan to issue draft guidance spelling out how it intends to regulate distributed manufacturing (DM) and point-of-care (POC) manufacturing of drugs and biologics. FDA expects that issuing such guidance may...
These instructions are to be used by manufacturers to report biological product deviations (BPD) to the Center for Biologics Evaluation and Research (CBER) that may affect the safety, purity, or potency of a distributed product....
How to get a marketing authorisation for an Advanced Therapy Medicinal Product (ATMP) so it can be sold and/or supplied in Great Britain. Read the press release from Medicines and Healthcare products Regulatory Agency published on...
Following the Chancellor’s speech on 22 November, Innovate UK, working with the Engineering and Physical Sciences Research Council, is investing an additional £145 million into the UK’s innovation ecosystem via the following investments. The increased...
A start-up is developing technology to build a pharmaceuticals factory in space that could help improve the lives of patients undergoing antibody treatments for cancer and other diseases. Currently, for patients undergoing antibody cancer treatments,...
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This draft guidance, within the context of FDA approval and license decisions, describes the use of alternative tools to assess manufacturing facilities identified in an NDA, an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...
