Scientific advice is the provision of advice to a company by the European Medicines Agency on the appropriate tests and studies required in the development of a medicine or on the quality of a medicine.

Scientific Advice (SA)

The regulatory body gives advice to a company on the appropriate tests and studies to be carried out 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. Following the Agency’s advice increases the probability of a positive outcome.

Scientific Advice (SA) From EMA

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

The EMA gives scientific advice by answering questions posed by companies. The advice is given in light of the current scientific knowledge, based on the documentation provided by the company. Companies can request scientific advice or protocol assistance, either during the initial development of a medicinal product before submission of a marketing-authorization application or later on, during the post-authorization 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.

The Agency provides scientific advice and protocol assistance in parallel with the United States Food and Drug Administration and /or HTA (Health Technology Assessment) bodies.