IPEC e-newsletter - Excipients Insight June 2018 - 19-06-18


Inside this issue


Recommended reading

EMA annual report published

The European Medicines Agency (EMA) has published an overview of the work of the European Medicines Agency (EMA) and highlights last year’s major achievements in protecting and promoting public and animal health in the EU. Some of the agency’s main projects and initiatives are highlighted, including the first public hearing, the launch of the new EudraVigilance system, the first anniversary of PRIME (PRIority MEdicines) and the new framework and action plan for academia – as well as the usual data on inspections and compliance.

European Medicines Agency

UK pharma cheers EU science announcement

Amid all the chaos and confusion of Brexit, the UK pharma industry finally has some good news to latch onto – it needn’t be excluded from EU’s flagship Horizon science programme. The European Commission has just published its budget proposal for the next phase of Horizon, setting aside almost €98bn for Horizon Europe - which gets underway in 2021 after the current Horizon 2020 comes to an end – and will extend out to 2027.


An important Brexit silver lining: the UK commits to align with EU rules on clinical trials

We welcome news that the UK will seek to align as closely as possible with the EU rules on clinical trials following Brexit. It means the EU and UK should be able to continue to collaborate and work together effectively after Brexit, draw on each other’s expertise and continue to run world class multi-member state trials, which will benefit patients in the UK, the EU and internationally. This also ensures that patients will gain access to trial medicines without delay.


EU-US mutual recognition: FDA gives two more EU countries seal of approval

Following a positive assessment by the US Food and Drug Administration (FDA), Lithuania and Ireland have today joined the list of EU countries recognised as capable to carry out good manufacturing practice (GMP) with regard to inspections of sites that manufacture human medicines. The FDA already recognised eight EU countries on 1 November, 2017 and four additional countries on 1 March, 2018. This brings the total number of countries accepted by the FDA to 14. The remaining member states will be assessed by the FDA on a rolling basis, to be completed by 15 July 2019.

European Commission

Brexit: EMA still clear on timelines

Despite the currently discussed "transition period", the European Medicines Agency EMA has emphasised that industry should be well prepared even for a so-called "hard Brexit". This was one of the main statements made in an industry stakeholder meeting on Brexit and operation of the centralised procedure for human medicinal products, held on 23 March 2018.

ECA GMP news




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