News - February 8, 2019
As of 9 February 2019, most prescription medicines supplied in the European Union are required to have a unique identifier (a two-dimension barcode) and an anti-tampering device on their outer packaging. These mandatory safety features are implemented through a delegated regulation that comes into application… read more
News - January 24, 2019
EURORDIS, the non-profit alliance representing rare diseases patient organisations will organise its 3rd Multi-Stakeholder Symposium on Improving Patients’ Access to Rare Disease Therapies on 13-14 February 2019 in Brussels, Belgium. The event will bring together stakeholders from various backgrounds to discuss sustainable solutions to improve… read more
News - January 10, 2019
EUCOPE, in collaboration with its member Sidley, as well as Navitas and PWC, is organising a conference on the 21st of February in Brussels, to discuss recent developments in pharma and medical devices law. The event will bring together senior and former members of the… read more
News - January 10, 2019
The European Medicines Agency (EMA) has released for public consultation a discussion paper on the use of patient disease registries for regulatory purposes – methodological and operational considerations. Patient registries are organised systems that use observational methods to collect uniform data on a population defined… read more
News - December 12, 2018
Gene & Cell therapies have arrived, and bring with them important challenges. Our Task Force, including some of our members active in gene and cell therapies, have worked on a position paper addressing some important questions raised by these novel techniques. The paper sets out… read more
News - November 27, 2018
The German Ministry of Health recently released a draft bill proposal that would introduce significant changes to the legislation on Orphan Medicinal Products (OMPs) and biosimilars in Germany. The bill, which has yet to pass the Cabinet for approval, sets out plans for mandatory registries… read more
News - November 21, 2018
In a letter addressed to Martin Selmayr, European Commission Secretary General, the European health community – patients, researchers, pharmaceutical companies – raised its concerns about the lack of contingency measures specific to the continued collaboration on health and asks for an epxlicit commitment from both… read more
News - November 15, 2018
Following the last Medical Devices Coordination Group (MDCG)-Stakeholders’ meeting, the European Commission (EC) published a ‘Rolling Plan’containing the list of essential implementing acts and actions for the transitional period as well as information on expected timelines and state-of-play. As highlighted in the plan, the EC… read more
News - September 19, 2018
With the Brexit clock ticking, both sides are now preparing for a possible ’no deal’ Brexit, which could impact on patient and public health across the EU27. The European health community will express their concern that with time running out, no substantial progress has been… read more
News - June 22, 2018
The pharmaceutical industry represented by AESGP[1], EFPIA[2], EUCOPE[3], EuropaBio[4], Medicines for Europe and PPTA[5] – henceforth referred to as ‘the pharmaceutical industry’ – generally welcomes the European Commission (EC)’s Proposal for a Regulation on HTA[6]. We understand the scope of the joint clinical assessments foreseen… read more
