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A new pathway supporting innovative approaches to the safe, timely and efficient development of medicines to improve patient access.
How to get scientific advice about your licence application from MHRA, including: submitting a request, your meeting with MHRA, fees.
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.
The MHRA is part of the Access Consortium along with the Therapeutic Goods Administration, Health Canada, Health Sciences Authority of Singapore and Swissmedic.
How to get a marketing authorisation for an Advanced Therapy Medicinal Product (ATMP) so it can be sold and/or supplied in Great Britain.
This guidance provides information on comparator products used in studies supporting abridged marketing authorisation applications
Project Orbis is a programme to review and approve promising cancer drugs helping patients access treatments faster.
How to apply for a clinical trial including eligibility, phases, model IMPDs, costs and how to make changes to your application.
The way you apply to licence biological products has changed
The VDEC clinical evaluation team works to support vaccine and therapeutic development by providing expertise in immunological and functional assays used to support clinical trials (Phase I to IV)
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.
The New Active Substance Work Sharing Initiative (NASWSI) has successfully approved several medicines through this international collaboration and continues to foster cooperation and strong relationships between its Access partners. The Biosimilar Work Sharing Initiative (BSWSI) builds on this success.
Pharmacy, prescription-only (POM), and general sale list (GSL) medicines: apply to move your medicine to a different classification.
Apply for an import certificate to import a medicinal product into the UK for veterinary use.
Following MHRA approval of a clinical trial, early breast cancer patients on endocrine-based therapy can benefit from a study with camizestrant.
An approach to payment for providers of IAPT services that links payment to patient outcomes as well as the provider’s levels of activity.
Investors and businesses may be legally required to tell the government about certain sensitive acquisitions under the National Security and Investment Act.
How we evaluated pre-exposure prophylactic (preventative) treatments for COVID-19.
Find out about coronavirus (COVID-19) treatments available outside of hospital, including information on free prescriptions and lateral flow tests.
From discovery to real-world impact, VDEC equips scientists with the expertise and facilities to navigate each step in the development of vaccines and therapeutics.
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