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Dr. Frank Pflueger

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In EU Pharmaceutical Package

New German Pharmaceutical Strategy Promises to Bolster Investment and Innovation, Implicitly Questioning the EU Pharmaceutical Review

by 6 Mins Read

On 13 December 2023, the German government published a long-awaited strategy outline of intended upcoming legislative measures to counter both the dwindling significance of Germany as a strong hub for pharmaceutical innovation, and threats to supply chain security. The proposed action items fall into 8 chapters, the most significant of which for pharmaceutical companies are briefly summarised below: 1. Strengthening clinical research; a model clinical trial agreement and centralised ethics committee The government intends to…

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In EU Pharmaceutical Package

The EU Pharmaceutical Package From a National Perspective: Member States’ First Reactions

by , , , and 6 Mins Read

The Proposal to revise the EU Pharmaceutical legislation has generated unprecedented levels of attention, not only across the industry but also amongst Member States with some countries already positioning themselves in favour or against some of the measures included in the proposed Regulation and Directives. In this article we review some of these positions, which focus mostly on the incentives regime and on the management of shortages. France In March 2023, a month before the…

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In Medical Devices

Waiting for your EU MDR Certificates? 5 Takeaways on the Intended Extension to Transitional Periods

by , , and 9 Mins Read

In brief In a recent EPSCO meeting, the European Commission (“Commission”) finally confirmed that it intends to extend the transitional period under the Medical Devices Regulation 2017/745 (MDR). In parallel, the Medical Device Coordination Group (MDCG) has published a Position Paper (2022-18) that offers a supplemental or short-term solution, allowing manufacturers to benefit from an exemption under Article 97 for a temporary period. While this means that the outlook for MDR implementation is more positive, the Commission’s approach is…

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