EIPG Newsletter

With its first guideline in the field of medical devices integral, the European Medicines Agency intends to clarify roles and responsibilities of the different stakeholders involved in the manufacturing and regulatory approval of a class of integrated products that is assuming an increasing importance as therapeutic option

The development of precisions medicines  requires to rethink the design of clinical studies in order to capture specificities of this class of medicines. Many are the points to be considered, from the use of companion diagnostics to the choice to run solid or liquid biopsies and the optimisation of phase 1 studies in order to identify early signs of toxicity

According to the Plan S initiative, results of all publicly-funded research projects should be published in open access journals starting 1st January 2020. But many criticisms to the project came from the different stakeholders

Ongoing negotiations at the Trilogue level agreed on the general topics of the new Horizon Europe research programme, but details are still missing about governance, specific missions and public-private partnerships

Next generation biotherapeutics, prescription digital therapeutics, neglected diseases, artificial intelligence and new roles within the pharma industry are just few of the emerging trends for the pharmaceutical market identified by IQVIA. While oncology and rare diseases will continue to boost the specialty medicines sector, increasing competition shall be also observed for biosimilars

A better integration of the many advancements in science and technology within pharmaceutical development, but also new models for both the pharma business and its interactions with regulatory authorities. EMA's consultation on the proposed strategy to govern the future of the European regulatory framework will be open to comments up to 30 June 2019

Data sharing and the re-use of research data requires the availability of common standards for their generation, conservation and access. Science Europe's guide on the international alignment of research data management provides core requirements to develop Data Management Plans and criteria to choose a trustworthy repository to store data

The monthly update from EIPG covers many issues, including preparation for the Brexit, the participation to the inter-association team of Interested Parties created by EFPIA, updates on GMPs and GDPs and Annual meetings organised by UPIP-VAPI and EUFEPS

Irish regulatory authorities have prepared detailed contingency plans to face the possible impact of hard Brexit on medicines supply in Ireland. The already available framework for shortages of medicines will be used to manage emerging issues. No stockpiling is necessary, advises HPRA

The Synthesis Report and Country Reports elaborated by the ESPN examine the current inequalities in access to healthcare in 35 European countries and provide possibile actions to be taken both at the central and Member States level to improve a fair access to cures for all citizens