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 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.
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.
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.
The so long waited decision is not a true decision: the new location of the European Medicines Agency (Ema) will be Amsterdam, but the...
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?”
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.
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.
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)
In the era of the personalisation of therapies, a better access to cure closely relates to the ability to sustain the very high costs of medicines that are far more sophisticaded than just some twenty years ago.