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Guidance for industry on flexible approaches to regulation we are taking during the COVID-19 outbreak.
The latest reproduction number (R) and growth rate of coronavirus (COVID-19).
Guidance to help local planning authorities assess and reflect strategic transport needs in Local Plan making.
How to show MHRA you're meeting good clinical practice (GCP) standards and what to expect from an inspection.
Information about the EU Regulations and their implementation in Northern Ireland
Apply for changes to your marketing authorisation, including minor variations type IA and IB, major variations type II and extensions.
The New Active Substance Work Sharing Initiative (NASWSI) has successfully approved several medicines through this international collaboration and continues to foster cooperation and strong relationships between its Access partners. The Biosimilar Work Sharing Initiative (BSWSI) builds on this success.
How to apply for marketing authorisation via this new procedure.
Actions that trial sponsors should consider to build resilience into clinical trial design
Guidance on Conditional Marketing Authorisations, exceptional circumstances Marketing Authorisations and national scientific advice
Urgent safety updates arising from pharmacovigilance data, including reported adverse events, for veterinary medicines authorised in the UK.
Data on the real-world efficacy of the COVID-19 vaccines.
Following MHRA approval of a clinical trial, early breast cancer patients on endocrine-based therapy can benefit from a study with camizestrant.
Submission dates and how the submissions using the EC decision reliance procedure work.
How to prepare for implementation and compliance of the Safety Features Regulation.
Guidance for the veterinary pharmaceutical industry on the production and submission of the Summary of Product Characteristics (SPCs) and product literature mock-ups.
Details of the process changes for established medicines, effective from 1 March 2024, which apply specifically to chemical products.
Get help to classify pharmaceutical products used to treat or prevent diseases or ailments (in humans or animals), including comparators used in clinical trials and placebos.
Guidance for the pharmaceutical industry on Marketing Authorisations for veterinary medicines.
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