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EMA Guidance: European Commission’s (EC) New Variations Guidelines
On 22 September 2025 , the European Commission published new variations guidelines in the Official Journal of the European Union. These...
Sharan Murugan
Sep 22, 20252 min read
EC Guidance: Transition from Clinical Trials Directive to the Clinical Trials Regulation
The European Commission (EC) has long recognized the importance of streamlining and harmonizing the regulation of clinical trials across...
Sharan Murugan
Jul 24, 20232 min read
EC MDCG: Med Dev Guidance on Significant Changes regarding the Transitional Provision MDR
The European Commission’s Medical Device Coordination Group (MDCG) released updated guidance "Guidance on significant changes regarding...
Sharan Murugan
May 13, 20231 min read
European Commission (EC) updated guide on Good Lay Summary Practice
The European Commission (EC) on 04-October-2021 has put out recommendations on finest practices for preparation, translation and...
Sharan Murugan
Oct 7, 20211 min read
MDCG Guidance on UDI Integration -European Comission
Medical Device Coordination Group Document (MDCG) published a guidance (MDCG 2021-19) note integration providing recommendations on how...
Sharan Murugan
Aug 6, 20211 min read