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How to apply for a clinical trial including eligibility, phases, model IMPDs, costs and how to make changes to your application.
How to get scientific advice about your licence application from MHRA, including: submitting a request, your meeting with MHRA, fees.
This guidance provides information on comparator products used in studies supporting abridged marketing authorisation applications
A new pathway supporting innovative approaches to the safe, timely and efficient development of medicines to improve patient access.
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.
Following MHRA approval of a clinical trial, early breast cancer patients on endocrine-based therapy can benefit from a study with camizestrant.
The MHRA is part of the Access Consortium along with the Therapeutic Goods Administration, Health Canada, Health Sciences Authority of Singapore and Swissmedic.
Following MHRA approval of a clinical trial, a study on Nuwiq, a recombinant FVIII therapy for the treatment of haemophilia A, can proceed.
Guidance for industry on flexible approaches to regulation we are taking during the COVID-19 outbreak.
Directory of current ICH Guidelines which have been implemented by the Medicines and Healthcare products Regulatory Agency.
These reports explain our assessment of the scientific evidence used to lead to regulatory decisions on the safety of medicines or medicines classes.
How to use a cost utility analysis to evaluate your digital health product.
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.
You can claim relief to pay no Customs Duty and VAT if you're importing therapeutic substances of human origin, blood-grouping or tissue-typing reagents, or related packaging, solvents and accessories.
How to use a before-and-after study to evaluate your digital health product.
How to get a marketing authorisation for an Advanced Therapy Medicinal Product (ATMP) so it can be sold and/or supplied in Great Britain.
Change your protocol, update your authorisation, report safety issues, submit safety updates and complete your end-of-trial study report.
Requirements for an Animal Test Certificate (ATC) to carry out the field trial of a veterinary medicine in animals (clinical trial) in the UK.
Information about when you need to submit substantial amendments to a clinical trial including changes to the trial sponsor or legal representative, Investigational medicinal product certification and importation.
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