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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.
Following MHRA approval of a clinical trial, a study on Nuwiq, a recombinant FVIII therapy for the treatment of haemophilia A, can proceed.
A new pathway supporting innovative approaches to the safe, timely and efficient development of medicines to improve patient access.
How to show MHRA you're meeting good clinical practice (GCP) standards and what to expect from an inspection.
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.
Change your protocol, update your authorisation, report safety issues, submit safety updates and complete your end-of-trial study report.
How to notify the MHRA of your intention to carry out a clinical investigation for medical devices.
This guidance provides information on comparator products used in studies supporting abridged marketing authorisation applications
The Medicines and Healthcare products Regulatory Agency (MHRA) has today (11 March 2024) approved the medicine quizartinib (Vanflyta) to be used alongside chemotherapy as first line treatment for adults who have acute myeloid leukaemia (AML).
Information and guidance on a range of medical devices for users and patients.
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.
The Medicines and Healthcare products Regulatory Agency (MHRA) has today (7 March 2024) approved the medicine ganaxolone (Ztalmy) as the first anti-seizure medication in the UK to treat cyclin-dependent kinase-like 5 (CDKL5) deficiency disorder (CDD).
A wholesale dealer in Great Britain may import Qualified Person certified medicines from the European Economic Area if certain checks are made by the ‘Responsible Person (import)’
What you need to know before you can place a medical device on the Great Britain market with a UKCA mark.
The MHRA is ready to provide any assistance for clinical trials applications submitted for COVID-19
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 investigators and sponsors should manage clinical trials during COVID-19
Comply with good manufacturing practice (GMP) and good distribution practice (GDP), and prepare for an inspection.
Don’t include personal or financial information like your National Insurance number or credit card details.
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