11/20/2023 0 Comments New ema![]() Request for Participation – Companies can apply for PSA from September 2023 until January 2025, by submitting an application form and its annexes to the EMA and the HTA Coordination Contact. ![]() HTA Coordination Contact – The G-BA (Gemeinsamer Bundesausschuss/Federal Joint Committee, Germany) is designated as the HTAbs Coordination Contact for centralized recruitment and practical coordination of participant HTAbs.Īssociated Experts – The EMA or the HTAbs may decide whether to involve healthcare professionals/clinical experts and patient representatives in their respective assessments. If fewer than two HTAbs are available after the selection process, the PSA continues as a simple regulatory-only EMA scientific advice.Ī company may not choose the HTAbs to be involved in its PSA. If an HTAb decides to participate, it may do so either (i) as an active participant, providing advice based on its national HTA requirements, or (ii) as an observer.Ī minimum of two active HTAbs is required for each PSA. HTAbs – National HTAbs may, at their discretion, participate or not in a PSA. The EMA and the HTAbs have specific roles and responsibilities.ĮMA – The EMA participates in the PSA through its Scientific Advice Working Party (“SAWP”), which provides general, regulatory-only scientific advice (advice on tests and trials necessary to demonstrate the quality, safety, and efficacy of medicinal products) when only the EMA is involved. Like the previous parallel scientific advice schemes, the interim PSA will provide scientific advice on initial evidence generation so that pharmaceutical companies can design their trials and generate data to adequately support not only their marketing authorization applications but also their pricing and reimbursement applications and Post Licensing Evidence Generation (“PLEG”). The Guideline in essence provides for a new pilot but on a rolling basis for about 16 months. Since then, parallel scientific advice has been replaced by pilot applications of the HTA Regulation, each with a limited application period. ![]() It was set up about 10 years ago on an informal basis, regularly evolved, and largely contributed to the adoption of the HTA Regulation. Parallel or joint EMA-HTAb scientific advice is not new. In November 2022, the Heads of Medicines Agencies (“HMA”) launched the second phase of their pilot project on simultaneous national-level scientific advice. In February 2023, the EMA organized a pilot project for high-risk medical devices by the expert panels created by the Medical Devices Regulation (“MDR”). Generally, opportunities to receive scientific advice are increasing in the EU. ![]() It explains the eligibility criteria, timelines, and procedure, as well as the role and responsibilities of each participating party. The Guideline organizes parallel scientific advice (“PSA”) by the EMA and national health technology assessment bodies (“HTAb”) on a rolling basis, for the period between September 2023 and January 2025 when the European Union (“EU”) Regulation 2021/2282 on health technology assessment (“HTA Regulation”) becomes operational. On July 3, 2023, the European Medicines Agency (“EMA”) and the European Commission published a Guidance on Parallel EMA/HTA body Scientific Advice for the Interim Period (“Guideline”).
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