EIPG Newsletter

Greece: 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.

EU: The European Medicines Agency moves to Amsterdam

The so long waited decision is not a true decision: the new location of the European Medicines Agency (Ema) will be Amsterdam, but the...

EIPG endorses key events organised by membership

The European Industrial Pharmacists Group has recently had the pleasure to endorse two events organised by its members: the 18th Panhellenic Pharmaceutical Congress and the conference “European Clinical Trial Day,  the future of clinical research: is the 536/14 regulation enough?”

Italy. Towards a new governance for the pharma sector

The “Documento di economia e finanze 2017” (DEF 2017), issued in September by the Italian Government, is the programmatic financial document upon which will be based Italy’s Budget Law 2018 (“Legge di Bilancio”), to be approved by the Parliament before the end of the current year.

Regulatory challenges of CAR-T cell therapies

The first-in-class new chimeric antigen receptor T cell (CAR-T) cell therapy – Novartis’ Kymriah™ (tisagenlecleucel, CTL019) for children and young adults with B-ALL cell that is refractory or has relapsed at least twice – has received FDA approval at the end of August 2017.

The new ICH E11 (R1) on pediatric studies

After the public consultation phase in 2016, the ICH E11(R1) Addendum on Clinical Investigation of Medicinal Products in the Pediatric Population closed step 4 of the ICH procedure in August 2017  and is now undergoing the implementation period (Step5)