News - January 24, 2019

EURORDIS Multi-stakeholder Symposium, 13-14 February, Brussels

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

EMA Public Consultation on Patient Registries

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 - November 27, 2018

Changes in sight for OMPs and biosimilars in Germany?

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

Brexit: Is long-term cooperation on health in jeopardy?

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 - June 22, 2018

Joint pharmaceutical industry statement on the Commission’s proposal for a Regulation on health technology assessment (HTA)

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