Scientific advice procedures – what makes a good briefing document? - Mogens Westergaard
3:05 PM - 3:45 PM
Medicine developers can request scientific advice from the EMA at any stage of development of a medicine. Scientific advice helps to ensure that developers perform the appropriate tests and studies, so that no major objections regarding the design of the tests are likely to be raised during evaluation of the marketing authorisation application (MAA). The Agency gives scientific advice by answering questions posed by medicine developers. The advice is given in light of the current scientific knowledge, based on the documentation provided by the medicine developer. Scientific advice is prospective in nature. It focuses on development strategies rather than pre-evaluation of data to support an MAA. Scientific advice received from the Agency is not legally binding on the Agency or on the medicine developer with regard to any future MAAs for the medicine concerned.
The medicine developer must prepare a briefing document including an introduction to the medicine under development, asking the developer’s questions, and presenting their own position on each question asked. The questions may concern pharmaceutical quality, non-clinical and clinical questions, methodological issues, and overall development strategy.
The scientific advice procedure includes a planning phase with/without a pre-submission meeting, followed by an evaluation phase without discussion meeting (40 days) OR with a discussion meeting with the company (70 days). The end product is a Final Advice Letter (FAL). It is drafted by the SAWP, and after adoption by the Committee on Human Medicinal Products (CHMP) it is finalised and sent to the medicine developer.
The session will outline the regulatory framework for the scientific advice procedure, briefly touch upon the available scientific guidelines and resources, and focus on a discussion around what characterises a good briefing document.