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Guidelines to provide developers of biosimilar products with a clear outline of the requirements in Great Britain.
Phase 2 of the Airlock will include seven additional technologies spanning AI-powered clinical note taking, advanced cancer diagnostics, eye disease detection tools, and obesity treatment support systems.
Extra information for the Medicines and Healthcare products Regulatory Agency (MHRA) and National Institute for Health and Care Excellence (NICE) Integrated Scientific Advice (ISA) service.
How manufacturers can apply for approval to supply a non-compliant medical device on humanitarian grounds.
Outlining the principles for the management and oversight of the import of investigational medicinal products (IMPs) to Great Britain from listed countries.
Requirements for sponsor representatives using EHR (electronic health records) in clinical trials.
Guidance on the submission, processing and assessment of all completed paediatric studies sponsored by marketing authorisation holders (MAHs).
Information on the implementation of changes to the licensing of medicines for human use in the UK following the agreement of the Windsor Framework.
Information and recommendations for manufacturers on the preparation and presentation of a periodic safety update report (PSUR).
Sets out medicines that can be moved to Northern Ireland to meet patient need.
Information and advice on submitting a nutritional product to the Advisory Committee for Borderline Substances (ACBS).
Information about how approved bodies help regulate medical devices and how to apply for approval.
How we engage and involve patients and the public in our regulatory decision-making.
Past and current clinical trials into therapeutic and antiviral treatments for COVID-19, how to take part, and which treatments have proven to be effective.
Information about how to register your homeopathic medicinal product through the Simplified Homeopathic Registration Scheme or the UK Homeopathic National Rules Scheme
Anyone in Northern Ireland selling medicines to the public via a website must still comply with the requirement to apply the EU common logo.
Documentation to support changes made to reporting Manufacturer Incident Reports (MIRs) and Field Safety Corrective Action Reports (FSCAs) to the MHRA following implementation of the Medical Devices (Post-market Surveillance…
This guidance has been produced in collaboration with the UK Kidney Patient Safety Committee (KPSC), to summarise known safety issues with dialysis and continuous renal replacement therapy (CRRT) and describe what to do to m…
Details of the process changes for established medicines, effective from 1 March 2024, which apply specifically to chemical products.
The review of the safety of isotretinoin has concluded.
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