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Information on comparator products used in studies supporting abridged marketing authorisation application.
How to apply for a clinical trial including eligibility, phases, model IMPDs, costs and how to make changes to your application.
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.
Comply with good manufacturing practice (GMP) and good distribution practice (GDP), and prepare for an inspection.
How to show the MHRA you're meeting good clinical practice (GCP) standards and what to expect from an inspection.
The MHRA will review applications for orphan designation at the time of a marketing authorisation (MA) or variation application.
The MHRA is part of the Access Consortium along with the Therapeutic Goods Administration, Health Canada, Health Sciences Authority of Singapore and Swissmedic.
New paper sets out UK regulator's intentions to overhaul rulebook for rare disease therapies in UK
Guidance for Applicants wishing to apply for a Promising Innovative Medicines designation, pre-submission meeting or an EAMS Scientific Opinion.
Guidance on using non-investigational medicinal products in a clinical trial.
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