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EIPG Newsletter

EU Commission’s proposal amending the transition period of the MRD regulation

The very strict timing to reach compliance to the new requirements established by regulation  (EU) 2017/745 (MDR), with the transition period ending 26 May 2024, poses many challenges to manufacturers of medical devices called to obtain a new certification for their products

Green light to the new corporate sustainability reporting directive (CSRD)

The Corporate sustainability reporting directive (CSRD) reached final approval by the European Council in November 2022. After publication in the EU’s Official Journal, the new directive shall be adopted by member states with 18 months

Unified Patent Court, the roadmap towards activation

The new Unified Patent Court is proceeding with the implementation of activities to prepare to the entry into force of the UPC Agreement, currently planned for 1 April 2023. Starting from this date, the Court will begin to receive cases

EIPG: Upcoming events and a call for consultation

An EIPG and a joint EIPG & EPSA Webinars are to be held in May 2021, an EAFP course VIRT2UE on Research Integrity is to be held in April & May 2021 and a call for consultation on the draft toolbox guidance to support quality data packages for PRIME MA applications ends at the end of June 2021

The economic footprint of the biotechnology industry in Europe: Focus in Pharma

A new report describes EuropaBio's vision for the future of European biotechnologies, a fast growing sector still waiting for some answers from the EU Commission to finally overcome all the barriers and implement its full potential

Comments to the public consultation on the new HERA agency

More than 150 comments on the proposal of the new HERA agency are available in the EU Commission's website after the closing of the public consultation phase, including also the positions of the main industrial and professional associations in the pharmaceutical and life sciences fields

Structured dialogue with the EU Commission to prevent shortages

The Structured dialogue launched by the EU Commission will see the collaboration of all the stakeholders to optimise the European operative framework for pharmaceutical manufacturing and distribution of critical and essential medicines

Generics medicines looking for improved access

The annual market report from Medicines for Europe highlights factors that may influence the access to the market for generic medicines. Several different analysis have been published in the scientific literature in the last decade

EIPG: Q&A follow up webinar session on MDR – Joint Statement on future modifications...

Dr. Deavin has kindly offered to provide a 10–15-minute summary of the Regulations, followed by a Question-and-Answer session on 9th March 2021 as there were a large number of participants who were unable to join the webinar on 3rd of February and insufficient time to answer a number of questions. A Joint Statement on future modifications to the Directive on the Recognition of Professional Qualifications has been discussed at length with our European partners

Human and veterinary medicines: EMA’s highlights of 2020

The European Medicines Agency approved last year 97 new human medicines and 20 veterinary ones. Many products are based on new active substances and innovative approaches to therapy. All achieved outcomes are described in the yearly reports published by the Agency