EUROPE – New Interim Guidance on Parallel EMA-HTA Body Scientific Advice

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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”). 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”)…
By: King & Spalding
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