![]() 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 Since then, parallel scientific advice has been replaced by pilot applications of the HTA Regulation, each with a limited application period.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. ![]() ![]() SSR Performance driver Mirko Bortolotti was once again Lamborghini’s best representative as he qualified sixth, beating the second Manthey EMA Porsche of Dennis Olsen.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”). ![]() Saturday winner and reigning champion Sheldon van der Linde finished right behind his team-mate Rast in the first qualifying group with a time that was only 0.018s down, which put him third on the grid ahead of the Bernhard Porsche duo Laurin Heinrich and Ayhancan Guven. The closest anyone came to beating Rast was Manthey EMA’s Thomas Prenining, the Porsche driver qualifying on the front row of the grid for a second race in succession after setting a best time of 48.773s. While a number of Porsche drivers showed rapid pace in a session that was supposed to be theoretically faster, no one was able to usurp Rast’s lap, with the 36-year-old clinching his 24th career pole in the DTM by 0.151s. The German driver then had to spend the next 20 minutes in the Schubert garage as he waited for the second group of drivers to complete their laptimes, with the DTM having gone for a split-qualifying format at the Norisring due to the short length of the track.
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