The European Medicines Agency (EMA) has released guidance on methods to be used in the design and conduct of post authorisation efficacy studies. The EMA has released a draft scientific guideline that outlines how post-authorisation efficacy studies (PAES) should be designed by companies to support regulatory decision making in the European Union (EU). These studies are conducted within the authorised indication after a medicine has been granted a marketing authorisation, to collect data on aspects of its benefits that can only be or need to be explored once the medicine is marketed. The results of these studies should translate into better labelling and better use of medicines by patients and prescribers in clinical practice. In addition, a guidance that describes the regulatory aspects for the fulfilment of imposed PAES is also published.
Access the EMA draft