EIPG Newsletter

EMA’s vision on evidence by design to evaluate the added therapeutic benefit

Evidence-by-design should guide the development of innovative therapies from the very early stages in order to provide the regulators with data supporting the added therapeutic value of the new treatment, thus leading to higher prices and reimbursement. EMA's representatives discussed how to reach this goal in a paper published by Nature Reviews Drug Discovery

How to address the choice of an API supplier

The choice of an API supplier is critical to ensure the quality of the pharmaceutical active ingredient. Many are the lessons taught by the sartans issue in order to avoid the possible formation of undesired toxic impurities along the manufacturing process. The scientific compentence of suppliers should be also evaluated

Greece: The National Chamber of Pharmacists

The current three distinct Greek associations might be coordinated by a single National Chamber of Pharmacists, representing the only reference point for the safeguard and the promotion of the profession, the keeping of registries of pharmacists and acting as the counterpart of institutions in the development of new laws. The examples active in French, Italy and Poland

EIPG: Guidelines open for consultation and coming in force, and a webinar on microbiome

Open consultations include the Discussion paper on patient disease registries, the guideline on the environmental risk assessment of medicinal products for human use and EMA's strategy on Regulatory Science to 2025. The guideline on the Trial master file will come into force on 6th June 2019. The webinar of 17th June will focus on the microbiome and stress–related psychiatric disorders

EIPG: General Assemblies of EIPG and a report from EAHP Congress

EIPG's vice-president for Communication Giorgos Panoutsopoulos provides details on the functioning of the Associations' General Assemblies. EIPG's executive director Jane Nicholson reports on the recent annual Congress of the European Hospital Pharmacists Group

Switzerland: The new Swiss regulatory framework

The new Swiss regulatory framework TPO IV harmonises many procedures to the one used by EU countries. GMP certificates released by Swissmedic are now available in the Eudra-GMDP database. Simplified procedures for certain categories of products and the revision of dispensing supply categories are among other features of the reform

Transparency, still a long road to reach the goal

Transparency remains an importat issue to be addressed at different levels of the supply chain of a medicinal product, especially with regard to the manufacturing of APIs in extra-EU countries. Reporting of results of clinical trials in public databases is also still greatly unsatisfactory both in the EU and US

The EURIPID Collaboration for pricing and reimbursement

The EURIPID Collaboration for pricing and reimbursement groups 24 national competent authorities with the aim to develop a standardised database to be used to keep control of prices for medicinal products

Transforming Big Pharma’s model

Value-based models are the new standard of the pharmaceutical business, using AI and breakthrough biotechnologies to develop personalised treatments. But the evolution of the sector yet requires a true involvement of patients to become the real player of their journey in the disease

Request of comments on recent EMA guidelines – European Medicines Shortages Research Network –...

EIPG members are asked to provide their comments on EMA guidelines on purity of water, development of topical products and environmental risk assessment. A report from the Supply Working Group of the European Medicines Shortages Research Network. The feedback on the EPSA mentoring project and a report on the General Assembly of UPIP-VAPI