Regulatory Blog

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Aug 31, 20211 min read

MHRA's New & updated Innovative Licensing and Access Pathway - UK

A new pathway supporting innovative approaches to the safe, timely, and efficient development of medicines to improve patient access was...

Jul 17, 20211 min read

Speedier Set Up for Clinical Research Trials – MHRA UK

The Medicines and Healthcare products Regulatory Agency (MHRA) is ensuring that the UK remains one of the best places in the world to...

Jul 7, 20211 min read

MHRA Delivery Plan 2021-2023 – UK MHRA

The Medicines and Healthcare products Regulatory Agency (MHRA) publishes its Delivery Plan 2021-2023 ‘Putting patients first. This Plan...

Jul 7, 20211 min read

Phase I Accreditation Scheme - UK MHRA

The MHRA phase I accreditation scheme is a voluntary scheme for organisations conducting phase I trials, for those conducting first in...

Jun 30, 20211 min read

Clinical trials: Apply for authorisation in UK – MHRA

This is a recently updated guidance that discusses How to apply for a clinical trial including eligibility, phases, model IMPDs, costs,...

May 10, 20211 min read

First authorisation under Project Orbis - UK MHRA

Project Orbis is an innovative programme coordinated by the US Food and Drug Administration (FDA) with Canada, Australia, Switzerland,...

May 8, 20211 min read

Guidance on the Licensing of Biosimilar Products - United Kingdom (MHRA)

What is a Biosimilar Medicine? Biosimilar medicine is a biological medicine that is developed to be highly similar and clinically...