Regulators Tackle Challenges With Pharmacoepidemiological Studies That Use RWD

An internationally harmonized framework for generating adequate evidence using fit-for-purpose real-world data to address regulatory questions on the safety of medicines is out for public consultation.

Global regulatory harmonization can help streamline efforts for companies and regulators • Source: Shutterstock

Feedback is being sought on proposed guidance that seeks to address the need for global regulatory harmonization when it comes to designing and analyzing pharmacoepidemiological studies that use real-world data (RWD) to study the safety of medicines.

The draft ICH M14 guidance is from the International Council for Harmonization and is now ready for public consultation.