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Scientific advice Scientific advice
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Regulatory guidelines Regulatory guidelines
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Further reading Further reading
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Cite
Extract
Scientific advice
The aim of scientific advice is to facilitate the development and availability of high-quality, effective and safe medicines. Scientific advice and protocol assistance can be sought from Regulatory Authorities regarding key areas of development of a medicinal product. Companies may request scientific advice either during the initial development of a medicinal product, before the submission of an MAA, or in the post-authorization setting. Seeking scientific advice is particularly important if a development plan deviates from the recommendations found in published regulatory scientific guidelines/pharmacopeia monographs, or if these documents are considered by the sponsor not to have sufficient detail. Specific scientific issues that may be addressed include quality, non-clinical, and clinical aspects of a development programme, pharmacovigilance plans and regulatory guidance.
Sponsors may seek scientific advice from the competent authorities of individual member states or from the EMA if pan-European advice is sought. Advice from the EMA is given by the CHMP on the recommendation of the Scientific Advice Working Party (SAWP). A fee, depending on the scope of the advice is usually payable. Fee reductions are available for designated orphan medicinal products, for the development of medicinal products for paediatric use and advanced therapy medicinal products, and for registered small and medium-sized enterprises.
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