The approach will be crucial to enhance the rapid development and approval of medicines ahead of and during public health emergencies. The overall goal is to ensure alignment between the regulatory approval requirements and national or ethics perspective on clinical trial applications.

The involvement of ethics experts in this process is made possible through a newly established Public Health Emergencies Ethics Advisory Group under the Accelerating Clinical Trials in the EU (ACT EU) initiative in collaboration with MedEthicsEU.

About scientific advice

Scientific advice is an important step in the development of a medicine, providing guidance on the best methods and study designs to generate robust evidence of a medicine’s benefits and risks. This advice helps to ensure that trials are well-designed, efficient and generate meaningful data for regulatory review.

About EMA’s Emergency Task Force (ETF)

The ETF is an advisory and support body that handles regulatory activities in…