Scientific advice and protocol assistance

The European Medicines Agency can give scientific advice and protocol assistance to companies involved in developing medicines:

• Scientific advice is when the Agency gives advice to a company on the appropriate tests and studies in the development of a medicine. This is designed to facilitate the development and availability of high-quality, effective and acceptably safe medicines, for the benefit of patients.
• Protocol assistance is the special form of scientific advice available for companies developing medicines for 'orphan' or rare diseases.

For human medicines, scientific advice is given by the Committee for Medicinal Products for Human Use (CHMP) on the recommendation of the Scientific Advice Working Party (SAWP). More information on the scope of scientific advice and protocol assistance is available in the guidance for companies.

The Agency provides scientific advice and protocol assistance in parallel with the United States Food and Drug Administration (FDA). For more information, see the general principles of the parallel scientific advice.

Requesting scientific advice

Companies can request scientific advice or protocol assistance either during the initial development of a medicinal product before submission of a marketing-authorisation application or later on, during the post-authorisation phase. Scientific advice and protocol assistance are particularly useful to companies developing a medicinal product when:

• there appears to be no or insufficient relevant detail in European Union guidelines or guidance documents, or in Pharmacopoeia monographs, including draft documents or monographs released for consultation;
• when the company chooses to deviate from the available guidance in its development plan.

For details on how to apply, see how to submit a scientific advice or protocol assistance request.