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EIPG Newsletter

The Netherlands: Innovation in the academia and the industry

The Dutch system for life sciences is rich of many pharmaceutical and biotech companies, universities and R&D centers working to develop innovative treatments using new models of research and new technologies such as gene therapy

The impact of Covid-19 on drug shortages

There may be a direct link between Covid-19 and possible drug shortages, as the current global lockdown is greatly impacting on the regular functioning of the international pharmaceutical hubs and supply chains in China, India, Italy and other European countries. The situation is evolving rapidly and needs accurate monitoring

Time to innovate the EU variation system

The current regulatory system is not reflecting anymore the availability of new digital technologies that may help to optimise the management of minor variations and it should be completely revised, says a report from Medicines for Europe

A new virus looking for effective treatments

Pharmaceutical companies and health authorities launched an enormous effort of R&D to identify medicines and vaccines against the Covid-19 infection immediately after the first Chinese outbreak of the pandemic. A brief outlook of the main ongoing activities

EIPG: Message from the President and Advisory Group on Competencies

Prof Claude Farrugia writes to all EIPG's members to sustain them in their important role related to the containment of the coronavirus epidemic. A summary of results of the work done by the Advisory group on Competencies is also provided

Affordability and innovation for sustainable access to medicines

Reaching a unique definition of fair price for pharmaceutical products is a pre-requisite to improve the sustainable access to medicines, according to a series of articles published in the BMJ and considering the issue from different perspectives, from vendors to buyers, from R&D costs to prices for generics and biosimilars, and access to vaccine in middle income countries

The principles to develop ePI

A document describing the key principles to develop ePI has been published by EMA, HMA and The European Commission. The guideline set the basis of the common technical standards to be used to overcome the issue of interoperability. The expected impact also includes a reduced time to work and make available regulatory variations

The MDCG’s guideline on the cybersecurity of medical devices

The guideline developed by the Medical Devices Coordination Group of experts describes the approach to be followed to assess, develop and implement all IT safety features of smart, interconnected medical devices and in vitro diagnostics

Lithuania: The status of HTA in Lithuania

The National Strategy on HTA in Lithuania is quite young and has been created with the financial support of the European Commission and the assistance of the Austrian HTA body. The healthcare system is still centred on hospitals and needs to be optimised, suggests a report from the OECD

EIPG: Calls for consultation on GMP and the 1st webinar of 2020

EIPG aims to ensure that will influence the evolution of EU regulations and guidelines concerning standards of quality, safety and efficacy of medicinal products. EMA has drafted a reflection paper on the responsibilities and activities of Marketing Authorisation Holders with respect to the European Commission’s guide to GMP for medicines for human and veterinary use. The 1st EIPG webinar of 2020 was held on February entitled “The Role of the Body Clock in Drug Development, Efficacy and Toxicity”