Mandate, objectives and rules of procedure of the Scientific Advice Working Party (SAWP)
As a main objective, the Scientific Advice Working Party shall provide scientific advice for medicinal products for human use and protocol assistance (i.e. scientific advice available for companies developing designated orphan medicines) to facilitate timely access of safe and efficacious medicinal products to patients and users of medicines by optimising Research and Development, reducing uncertainties in regulatory outcomes, and accelerating time to approval of a marketing authorisation application. Furthermore, the Scientific Advice Working Party will bring forward scientific advice to facilitate proactive pharmacovigilance planning, and integrated advice on safety, quality and efficacy through-out the lifecycle of the product. The SAWP shall therefore encourage Applicants to engage, as early as possible, in an ongoing dialogue with the Agency on the development of their product. The European Medicines Agency shall establish the best possible environment for the provision of scientific advice and protocol assistance, ensuring through its scientific committees flexibility towards applicants and consistency between scientific advice and protocol assistance given to applicants.
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