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EIPG Newsletter

Affordability and innovation for sustainable access to medicines

Reaching a unique definition of fair price for pharmaceutical products is a pre-requisite to improve the sustainable access to medicines, according to a series of articles published in the BMJ and considering the issue from different perspectives, from vendors to buyers, from R&D costs to prices for generics and biosimilars, and access to vaccine in middle income countries

The principles to develop ePI

A document describing the key principles to develop ePI has been published by EMA, HMA and The European Commission. The guideline set the basis of the common technical standards to be used to overcome the issue of interoperability. The expected impact also includes a reduced time to work and make available regulatory variations

The MDCG’s guideline on the cybersecurity of medical devices

The guideline developed by the Medical Devices Coordination Group of experts describes the approach to be followed to assess, develop and implement all IT safety features of smart, interconnected medical devices and in vitro diagnostics

Lithuania: The status of HTA in Lithuania

The National Strategy on HTA in Lithuania is quite young and has been created with the financial support of the European Commission and the assistance of the Austrian HTA body. The healthcare system is still centred on hospitals and needs to be optimised, suggests a report from the OECD

EIPG: Calls for consultation on GMP and the 1st webinar of 2020

EIPG aims to ensure that will influence the evolution of EU regulations and guidelines concerning standards of quality, safety and efficacy of medicinal products. EMA has drafted a reflection paper on the responsibilities and activities of Marketing Authorisation Holders with respect to the European Commission’s guide to GMP for medicines for human and veterinary use. The 1st EIPG webinar of 2020 was held on February entitled “The Role of the Body Clock in Drug Development, Efficacy and Toxicity”

Norway: Initiative to lower drug prices in nine European Countries

The International Horizon Scanning Initiative (IHSI) aims to develop a new database providing information on new pharmaceuticals supporting a more coordinated approach of the adhering countries to price negotiations with the industry

EIPG: Medicines Shortages at the spotlight of the European Parliament Pharma Watch

The latest parliamentary questions, declarations, proposals and positions concerning industrial pharmacy from the European Parliament along with the latest regulatory news, consultation documents, and adopted guidelines and legislation from EU are indexed at EIPG’s website

New technologies to boost healthcare

Many technologies are expected to reach their maturity during year 2020. The digital transformation shall reshape the healthcare systems and the way services will be provided to patients, as well as many industrial activities

EMA’s view on Pharmacovigilance in 2030

An article published in Clin. Pharmacol. & Therap. by EMA's representatives illustrates the Agency's view on how pharmacovigilance will look like in 2030. A recently published report also summarises the results obtained so far in this rapidly evolving field, fundamental to ensure the efficient and safe use of medicinal products

Towards the Brexit’s transition phase

The Brexit’s transition phase will start on 31 January 2020; negotiations with the EU should close by the end of the year, while June is the term for the UK government to ask for an extension of the period. The Brexit Health Alliance set its priorities for the negotiations. The pharmaceutical industry welcomed results from the general elections