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Monthly update from EIPG – February 2018

During the last month EIPG's representatives met the the French Ordre des Pharmaciens. Updates also from the Bureau Meeting and on the National Medicines Verification Organisation

From UK: An app to measure glucose without the need of blood samples

Just place a fingertip over the camera lens of the smartphone to read glycemic levels in blood: it's the promise of a new app developed in UK by Epic Health

Exome sequencing of genetic data to speed up R&D

A new pre-competitive consortium led by Regeneron will fund the exome sequencing of the biological samples obtained from the half million volunteers adhering to the UK Biobank

ICMRA: towards global standards for track-and-trace systems

The International Coalition of Medicines Regulatory Authorities (ICMRA) adopted new Recommendations to align track and trace (T&T) systems at the international level in order to reach interoperability

What is going on in neurosciences?

Research in Alzheimer's and Parkinson's diseases is suffering a difficult moment due to the many failures in clinical trials. While Pfizer and Merck leaved the challenge, Bill Gates invested $ 50 million in the Dementia Discovery Fund

New measures on the entry of new medicines in the Greek market

The Greek pharmaceutical sector is under pressure due to the Government's new policy that delays the launch of new innovative medicines for up to four years and adds an extra rebate of 25% for two years. Many companies are considering to stop the supply of innovative drugs.

The first digital pill soon on the market

The era of digital medicines is here: the first “digital pill” was approved by the Food and Drug Administration on November 13th, 2017 and other technologies are under development in the research labs.

The draft of the new Annex 1 is open to consultation

The new Annex 1 of the GMPs on the "Manufacture of Sterile Medicinal Products" has been published by the European Commission and is currently open to consultation until 20 March 2018. The structure of the document has been revised compared to the previous version.

Updates on the Brexit procedure

EMA published new Questions & Answers to help the pharmaceutical companies updating their authorisation dossiers in time to be ready to meet the new requirements that shall come into force with the Brexit.

EIPG’s Webinar on Paediatrics and EMA Meeting with Interested Parties

The webinar on “Development and regulatory approval of new medicines for children” is available in the Members Area of the EIPG website. EIPG's representative took part to the GMDP-IWG meeting organised by EMA in December 2017.