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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...

Sharan Murugan
Jul 7, 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,...

Sharan Murugan
Jun 30, 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,...

Sharan Murugan
May 10, 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...

Sharan Murugan
May 8, 20211 min read
