![]() More detailed information on how to apply for SNSA and additional documents and information can be found at Heads of Medicines Agencies: EU-Innovation Network (EU-IN) (hma.eu) (search for SNSA). to support new innovative therapeutic indications. Prior to clinical trials intended to facilitate repurposing of authorised medicinal products e.g.EMA scientific advice should continue to be used for scientific advice related to the suitability of the proposed clinical development to support a centralized marketing authorisation application. phase I/II clinical trials, especially where there is limited existing regulatory guidance. To inform the early-stage development of innovative products for which clinical trials are planned, e.g.Prior to applying for funding grants to support non-commercial clinical trials (academic researchers).Where during the SNSA the involved NCAs agree that the questions raised would benefit from discussions at the Clinical Trial Coordination Group (CTCG) level, it is also possible to obtain CTCG-coordinated clinical trial expert feedback as part of the SNSA procedure. In preparation for clinical trials (CT) applications to be performed in more than one MS.The following are examples of scenarios where developers may choose to seek SNSA: The experience gained during the SNSA pilot will be used to further develop the process and the provision of clinical trial-related advice as part of ACT EU Priority Action 7 (ACT EU PA7). It will facilitate sponsors / developers to obtain clinical trial-related national scientific advice from National Competent Authorities ( NCA) in Member States (MS) where they intend to perform clinical trials. In conjunction with the ACT-EU initiative, this phase of the SNSA pilot will have a specific focus on scientific advice to facilitate clinical trials (CT) within Europe. Following endorsement by the Heads of Medicine Agencies ( HMA), phase 2 of the SNSA pilot will run for a two-year period until the end of 2024. ![]() The format is intended to enhance the quality and consistency of such advice. SNSA is intended to be used in situations where an applicant wishes to obtain national scientific advice from more than one NCA at the same time. Simultaneous National Scientific Advice (SNSA) Periodic Safety Update Reporting (PSUR) - Synchronisation and Work-sharing.Task Force (veterinary) on Antimicrobial Issues.Pharmacovigilance Working Party - veterinary.Homeopathic Medicinal Products Working Group.Clinical Trials Facilitation and Coordination Group.European Medicines Agencies Co-operation of Legal and Legislative Issues (EMACOLEX).Working Group of Communication Professionals.HMA Working Group of Biosimilars (BSWG).HMAv Task Force on coordination of the Implementation of the Veterinary Regulation (TFCIVR).HMA/EMA Joint Task Force on Availability of authorised medicines for human and veterinary use (TF AAM).EU Network Training Centre (EU-NTC) - former OTSG.European Surveillance Strategy Working Group.EU Network Pharmacovigilance Oversight Group.Benchmarking of European Medicines Agencies.
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