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Information on comparator products used in studies supporting abridged marketing authorisation application.
Read about talking therapies and counselling for mental health problems.
How to apply for a clinical trial including eligibility, phases, model IMPDs, costs and how to make changes to your application.
New regulations effective today will make it faster and easier for cutting-edge cancer treatments and personalised gene therapies to be made right where patients are treated.
How to get a marketing authorisation (MA) for an advanced therapy medicinal product (ATMP) so it can be sold and/or supplied in the United Kingdom.
The MHRA is part of the Access Consortium along with the Therapeutic Goods Administration, Health Canada, Health Sciences Authority of Singapore and Swissmedic.
Guidance on conditional marketing authorisations, exceptional circumstances marketing authorisations and national scientific advice.
Guidance for Applicants wishing to apply for a Promising Innovative Medicines designation, pre-submission meeting or an EAMS Scientific Opinion.
Guidance for industry on flexible approaches to regulation we are taking during the COVID-19 outbreak.
Comply with good manufacturing practice (GMP) and good distribution practice (GDP), and prepare for an inspection.
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