Public authority · France
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FRANCE - Secrétariat général des Affaires européennes filed 4 positions between 13 Dec 2020 and 27 Apr 2021, across 4 of the 583 legislative files tracked here.
FR supported the general objectives and the different options for the evolution of the scheme. The revision of the EU texts will make it possible to adapt and speed up MA procedures in line with scientific and technical developments.
Filed in French · English published by the European Commission
The French authorities (FAs) welcome significant and structured progress made since the publication of the European Strategy for Data in February 2020, including the proposed legislative roadmap and available financial instruments such as the TEHDaS Joint Action, which have allowed to create a catalyst moment around the creation of a future European Health Data Space (EHDS).
France is not in favour of option 1 as it would not reinforce cross-country harmonisation of quality & safety standards nor protection of donors nor benefit patients relying on BTC therapies. FR supports option 2, which allows the consultation & implication of representatives from BTC establishments & experts from all over EU.
The French authorities (FAs) welcome the significant advances that Regulations (EC) No. 141/2000 (orphan medicinal products for rare deseases) and (EC) No. 1901/2006 (medicinal products for paediatric use) have made possible since their entry into force.
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Organizations that also filed on at least two of the same consultations. A shared interest in the same dossiers — not evidence of coordination, and we do not suggest any.
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