On 22 February 2022, the U.S. Food and Drug Administration (FDA or the Agency) announced that it was issuing a proposed rule to align the Agency’s current Good Manufacturing Practice (GMP) requirements for medical devices, codified at 21 C.F.R. Part 820 and known as the Quality System Regulation, with the international consensus standard ISO 13485:2016 (the ISO). This reflects a years-long effort by the Agency to better harmonise the U.S. requirements with that of many foreign regulators. For example, in the European Union, the ISO is listed in the EU legislation, meaning that a medical device that conforms to this standard is presumed to be in conformity with the EU regulatory requirements on quality management systems for medical devices. This harmonisation should, therefore, provide some consistency between jurisdictions and enable companies to streamline their processes between countries.
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Regulation
Update on the European Commission’s proposed new pharmaceutical strategy
By Nadia Gracias, Peter Saban & Jackie Mulryne on
At the end of 2020, the European Commission set out its vision to build a European Health Union with its announcement of the new pharmaceutical strategy for Europe (the new Strategy). As we discussed in a previous blog, the new Strategy seeks to introduce new policies and ideas, whilst bringing into the spotlight long standing challenges which were exacerbated by the Covid-19 pandemic. The new Strategy puts forward numerous proposals for legislative reforms that are likely to affect the regulation of the entire life cycle of a medicinal product and the regulation of medical devices. As a reminder, the key elements of the new Strategy relate to innovation, availability, accessibility, affordability, and supply of medicinal products.
In this post, we focus on the developments in the first half of 2021, including a pilot project launched by the European Medicines Agency (EMA) on market access and the Commission’s Roadmap on revisions to the pharmaceutical legislation.Continue Reading Update on the European Commission’s proposed new pharmaceutical strategy
European Commission proposes a new pharmaceutical strategy for Europe
As part of its vision to build a European Health Union, the European Commission announced the new pharmaceutical strategy for Europe (the new Strategy) on 25 November 2020. The new Strategy introduces new policies and ideas but also brings into the spotlight long standing challenges which were recently exacerbated by the coronavirus outbreak. The new Strategy puts forward numerous proposals for legislative reforms that are likely to affect the regulation of the entire life cycle of a medicinal product. Some of these revisions also affect the regulation of medical devices. The main elements of the new Strategy relate to innovation, availability, accessibility, affordability, and supply in relation to medicinal products.
In this post, we focus on the key proposed regulatory changes expected to impact the pharmaceutical industry. The post also discusses the implications of the new Strategy from the EU competition law perspective.
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The European Commission proposes a Regulation for COVID-19 clinical trials conducted with medicinal products containing or consisting of GMOs
By Dr Beatriz San Martin & Eftychia Sideri on
As part of the strategy to fight COVID-19, the European Commission has proposed a Regulation to facilitate the conduct of clinical trials using medicinal products containing or consisting of Genetically Modified Organisms (GMOs).
The European Commission recognises that the applicable regulatory framework in relation to GMOs is unable to adequately address the challenges created by the pandemic. While some vaccines in development contain attenuated viruses or live vectors, which may fall within the definition of a GMO, there is uncertainty on the interactions between the GMO regulatory framework and the legislation on clinical trials and medicinal products. This is further aggravated by the absence of a common approach by the EU Member States.
Continue Reading The European Commission proposes a Regulation for COVID-19 clinical trials conducted with medicinal products containing or consisting of GMOs