EIPG Newsletter

The sustainability of the business model for advanced therapies

The current business model for advanced therapies is no longer sustainable and restricts access of patients to what might likely prove to be in many instances resolutive therapeutic interventions. The debate is ongoing to identify the most affordable solution, but skepticism has still to be defeated

Regulators launched activities to prepare for the Brexit

While in the UK MHRA will not be longer considered to sign assessment contracts with EMA, the Dutch authority MEB is closing collaboration agreements with small European countries to reinforce their regulatory capabilities and future role as Reference Member States. Actions have also been planned by the HMA/EMA Task Force for the availability of medicines

Trends in the European medical technology industry, 2018

The European medical technology industry is wealthy and showed positive trends in 2016, according to Medtech Europe annual report. The leadership for number of patent applications acknowledges the very high innovative potential typical of this fast growing industrial sector

From the Netherlands: The Dutch approach to expensive medicines

In the Netherlands the debate on high prices of medicines is very hot, and some hospitals are trying to manufacture expensive drugs in their internal pharmacies in order to keep prices under control. But it might prove not a so simple challenge to be achieved

Global Harmonisation of Quality Standards for Medicines: report of a session at the 2018...

Par Tellner has reported about ICH's activities on the Global Harmonisation of Quality Standars for Medicines at the 2018 FIP Congress in Glasgow, including the process for the selection of new topics to be addressed and challenges and opportunities for the future of the association

Italy has overtaken Germany for pharmaceutical production

2018 is not a good year for Germany: after the elimination of its football team at the World Championship in Russia, another drawback came...

From Malta: Preparations for the impact of Brexit on the pharmaceutical supply chain in...

Malta is heavily dependent upon the United Kingdom and Ireland for the supply of medicinal products. Preparations to limit the impact of the Brexit on the import of pharmaceutical products still lag behind, with the possible risk of shortage of medicines on the island after 30 March 2019

Pharma companies are not yet ready for the Brexit

According to the survery run by EMA, many pharma companies based in the UK have not yet planned the activation of the necessary regulatory procedures to prepare for the Brexit. UK's new position of third country might require transfer of MAHs, batch release, quality control, site of import, QPPV and PSMF

Pre-clinical to clinical boundary, the key to success

The correct identification of the pre-clinical to clinical boundary may represent the key to success for early-stage development of pharmaceuticals. The issue has been discussed in a joint workshop held by UK's Association of British Pharmaceutical Industry and the Academy of Medical Sciences

Monthly update from EIPG: Consultation calls and Coming into effect documents

Several consultation calls relevant for industrial pharmacists are closing by the end of September 2018. A dedicated page on the EIPG's website also summarises guidelines coming into effect on 1st September 2018