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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 the MHRA makes decisions on when a product is a medical device (borderline products), and which risk class should apply to a medical device.
If you're advertising or marketing, including direct marketing, you must be accurate and honest and follow the advertising codes of practice
Get help to classify textiles and which headings and codes to use.
How to package medicines for sale and what information you must provide to consumers and healthcare professionals.
Submission dates and how the submissions using the EC decision reliance procedure work.
The UK government's design principles and examples of how they've been used.
Information and guidance on a range of medical devices for users and patients.
How investigators and sponsors should manage clinical trials during COVID-19
Advice and guidance on the health needs of migrant patients for healthcare practitioners.
Proposed updates to the lists of standards for businesses.
Guidance primarily aimed at local responders covering some humanitarian issues that may arise during the recovery phase of an emergency in the UK.
How to use an interrupted time series to evaluate your digital health product.
Information on trade sanctions, arms embargoes and trade restrictions, including trade controls, transit controls and restrictions on terrorist organisations.
How to show MHRA you're meeting good clinical practice (GCP) standards and what to expect from an inspection.
Guidance for staff of responder agencies, particularly senior officers or managers involved in emergency response and recovery preparations.
Guidance for exporting nuclear equipment, material and technology that appears on what is known as the 'Trigger List'.
Guidance for hospitals, tissue establishments and fertility clinics for ensuring the quality and safety of human organs, tissues and cells (including reproductive cells).
Guidance to help organisations choose a monitoring approach for stack emissions to air that meets Environment Agency and MCERTS requirements (formerly part of M2).
Pharmacovigilance system requirements
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