Search
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: Get Scientific Advice from MHRA- Comprehensive Guide
Navigating the regulatory landscape for medicines in the UK can be complex, especially as requirements evolve and innovation accelerates....
Sharan Murugan
Jun 183 min read
EMA Announcement: Regular Scientific Advice Procedure for High-Risk Medical Devices
In collaboration with the European Commission, the European Medicines Agency (EMA) has launched (10 February 2025) a regular...
Sharan Murugan
Feb 122 min read
EMA Guidance: Scientific Advice and Protocol Assistance
European Medicines Agency (EMA) recently updated (14-October-2022) its guidance on "Scientific advice and protocol assistance" and also...
Sharan Murugan
Oct 17, 20221 min read
EMA Guidance for Applicants seeking Scientific Advice and Protocol Assistance
This guidance document addresses a number of questions that users of the scientific advice or protocol assistance procedures may have and...
Sharan Murugan
Jan 16, 20221 min read