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These reports explain our assessment of the scientific evidence used to lead to regulatory decisions on the safety of medicines or medicines classes.
Further measures to be introduced to ensure patients who are prescribed montelukast for the treatment of asthma are informed of the risk of neuropsychiatric reactions
The MHRA is ready to provide any assistance for clinical trials applications submitted for COVID-19
Apply for a promising innovative medicine (PIM) designation or scientific opinion for your medicine from MHRA.
How to notify the MHRA of your intention to carry out a clinical investigation for medical devices.
Information for patients, healthcare professionals and developers of new medicines
The Medicines and Healthcare products Regulatory Agency regulates medicines, medical devices and blood components for transfusion in the UK. MHRA is an executive agency, sponsored by the Department of Health and Social Care .
The MHRA has today set out its strategic approach to artificial intelligence (AI)
Safety leaflet to help you understand the latest information about the effects of pregabalin during pregnancy.
Details of the process changes for established medicines, effective from 1 March 2024, which apply specifically to chemical products.
Information and guidance on a range of medical devices for users and patients.
Search for information about medicines including patient information leaflets (PILs), details on how the medicine can be used (SmPCs) and scientific reports (PARs).
The MHRA has reviewed the latest evidence relating to the very rare risk of PRES and RCVS associated with medicines containing pseudoephedrine
Directory of current ICH Guidelines which have been implemented by the Medicines and Healthcare products Regulatory Agency.
Information for patients, public and health care professionals.
Guidance on Conditional Marketing Authorisations, exceptional circumstances Marketing Authorisations and national scientific advice
Covering thalidomide, lenalidomide, and pomalidomide: temporary guidance for pregnancy prevention arrangements for patients taking them during COVID-19
How test manufacturers or distributors can apply for approval of their tests to sell on the UK market.
A. Menarini Farmaceutica Internazionale Srl is recalling a specific batch as a precautionary measure due to the distribution of Invokana 300mg in Northern Ireland in packaging intended for the Greek market.
Guidance for organisations involved in any aspect of the pharmaceutical lifecycle or GLP studies regulated by MHRA, covering the approval of paper documents when working from home
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