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EMA Guidance: ETF Scientific Advice that facilitates Clinical Trial Authorisations (SA-CTA) and 2025–2027 IRIS Roadmap
The European Medicines Agency (EMA) recently published new guidance titled “ Guidance for applicants: the ETF Scientific Advice that facilitates Clinical Trial Authorisations (SA-CTA ) ”, outlining how sponsors and applicants can benefit from harmonised scientific advice to accelerate clinical trial authorisation across the EU. 1. What the SA-CTA Scientific Advice Is The guidance explains that the SA-CTA scientific advice is a specialised type of EMA advice developed under th
Sharan Murugan
Nov 234 min read
UK MHRA Guidance: Applying for Clinical Trial Authorisation (CTA)
On 22 August 2025 , the Medicines and Healthcare products Regulatory Agency (MHRA) published an updated version of its guidance “...
Sharan Murugan
Aug 232 min read
UK MHRA: Clinical Trials for Medicines: Apply for Authorisation in the UK
Recently (12 October 2023) UK's Medicines and Healthcare Products Regulatory Agency (MHRA) released updated guidance on "Clinical Trials...
Sharan Murugan
Oct 14, 20232 min read
Statement for Extensive Public Access to Clinical Data- ICMRA and WHO
The International Coalition of Medicines Regulatory Authorities (ICMRA) and World Health Organisation (WHO) calls on the pharmaceutical...
Sharan Murugan
May 8, 20211 min read