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A new pathway supporting innovative approaches to the safe, timely and efficient development of medicines to improve patient access.
The requirements for 3D printed products will depend on whether they are classed as medical devices, personal protective equipment (PPE) or both.
How to notify the MHRA of your intention to carry out a clinical investigation for medical devices.
Directory of current ICH Guidelines which have been implemented by the Medicines and Healthcare products Regulatory Agency.
How to apply for a clinical trial including eligibility, phases, model IMPDs, costs and how to make changes to your application.
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.
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.
What you need to know before you can place a medical device on the Great Britain market with a UKCA mark.
How to use a cost benefit analysis to evaluate your digital health product.
Guidance for industry on flexible approaches to regulation we are taking during the COVID-19 outbreak.
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.
This toolkit is for Innovation Passport holders following the Innovative Licensing and Access Pathway (ILAP) and provides activities to support the design and development of medicines.
How to conform with the legal requirements for placing medical devices on the market.
Change your protocol, update your authorisation, report safety issues, submit safety updates and complete your end-of-trial study report.
This guidance provides information on comparator products used in studies supporting abridged marketing authorisation applications
How to show MHRA you're meeting good clinical practice (GCP) standards and what to expect from an inspection.
How to register your medical devices with the Medicines and Healthcare products Regulatory Agency (MHRA) for the markets in Great Britain and Northern Ireland
An overview of the future requirements for rapid COVID-19 diagnostic assays for antigen lateral flow devices.
Get help to classify herbal medicines, vitamins, food preparations, supplements and tonics for import and export.
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