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EMA Guidance: Scientific Advice and Protocol Assistance

European Medicines Agency (EMA) recently updated (14-October-2022) its guidance on "Scientific advice and protocol assistance" and also the CHMP protocol assistance scientific advice briefing document template was updated.

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

EMA provides scientific advice to ensure that high-quality, safe, effective, and cost-effective medicines are developed on time, according to scientific standards.

By using this guidance, developers can ensure that they conduct the appropriate tests and studies so that they are unlikely to be objected to during the assessment of their marketing authorization application.

It does not matter whether a medicine is eligible for centralized authorization or not, developers can ask EMA for guidance and direction on the best methods and study designs at any stage of its development to generate robust information about how well a medicine works and how safe it is.

Scientific advice will be given by the Scientific Advice Working Party (SAWP)/ Committee for Medicinal Products for Human Use (CHMP) on questions concerning quality, non-clinical and clinical aspects, and exploratory or confirmatory safety and efficacy studies, for pre- or post-authorization activities including risk-management programs.

Click this LINK to know how this guidance supports the applicants for scientific advice and protocol assistance also download the updated scientific advice briefing document template by clicking this LINK


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