Regulatory Blog

The Regulatory News you Need to Know,Share & Grow

Jul 24, 20232 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...

May 7, 20232 min read

EMA Interim Guidance: How to Approach the "PPD and CCI" while using CTIS

Last Week (03 May 2023) the European Medicines Agency released an Interim guidance document on "How to Approach the Protection of...

May 8, 20211 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...