Matters of a purely regulatory nature (please use the ‘Submission Details’ field in your submission via the IRIS portal).Changes to the key elements of Paediatric Investigation Plan (PIP) measures and paediatric waivers or deferrals, which EMA addresses via a paediatric procedure.Adequacy of planned paediatric studies or an overall development plan to support a paediatric indication, which EMA addresses via a PIP submission.Compassionate use, advanced therapy medicinal product (ATMP) classification, PRIME eligibility, and accelerated assessment.Questions about the topics below are outside the scope of scientific advice: Are the plans to follow the long-term safety of the product appropriately designed?.Is the medicine being compared with an appropriate control?.Does the study last long enough and include enough patients to provide the necessary data for the benefit-risk assessment?.Is the proposed plan to analyse results appropriate?.Are the planned measures to assess the benefits of a medicine valid and relevant?.Are the patients to be included in a study sufficiently representative of the population for whom the medicine is intended?.overall development strategy (e.g., conditional marketing authorisation, bridging strategy for generics, safety database), significant benefit for maintaining orphan designation, and paediatric developments.statistical tests to use, data analysis, modelling and simulation) how best to measure effects in a study, post-authorisation activities including risk management plans) appropriateness of studies in patients or healthy volunteers, selection of endpoints, i.e. toxicological and pharmacological tests designed to show the activity of the medicine in the laboratory) manufacturing, chemical, pharmaceutical and biological testing of the medicine) Questions during scientific advice can relate to: This also helps avoid patients taking part in studies that will not produce useful evidence.įor human medicines, scientific advice and protocol assistance are given by the Committee for Medicinal Products for Human Use ( CHMP) on the recommendation of the Scientific Advice Working Party (SAWP).įor information on how to request scientific advice from EMA, see Requesting scientific advice or protocol assistance from EMA. Scientific advice helps to ensure that developers perform the appropriate tests and studies, so that no major objections regarding the design of the tests are likely to be raised during the evaluation of the marketing authorisation application. EMA provides scientific advice to support the timely and sound development of high-quality, effective and safe medicines, for the benefit of patients.Īt any stage of a medicine's development, a developer can ask guidance and direction from EMA on the best methods and study designs to generate robust information on how well a medicine works and how safe it is, regardless of whether the medicine is eligible for the centralised authorisation procedure or not. The European Medicines Agency (EMA) can provide medicine developers advice on the most appropriate way to generate robust evidence on a medicine's benefits and risks.
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