Scientific advice

Companies can request scientific advice from the European Medicines Agency at any stage of development of a medicine, whether the medicine is eligible for the centralised procedure for marketing authorisation or not.

Scientific advice helps the company to make sure that it performs 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. Such major objections can significantly delay the marketing of a product, and, in certain cases, may result in refusal of the marketing authorisation. Following the Agency’s advice increases the probability of a positive outcome.

The Scientific Advice Working Party (SAWP) and Committee for Medicinal Products for Human Use (CHMP) give scientific advice by answering questions posed by companies. The advice is given in the light of the current scientific knowledge, based on the documentation provided by the company. It is not the role of the CHMP to substitute the industry's responsibility for the development of their products.

Scientific advice is prospective in nature. It focuses on development strategies rather than pre-evaluation of data to support a marketing-authorisation application.

Scientific advice received from the Agency is not legally binding on the Agency or on the sponsor with regard to any future marketing-authorisation applications for the medicine concerned.