Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. Austria Pressures Healthcare Professionals, Physicians to Report Adverse Events The Austrian Federal Office for Safety in Health Care (BASG) has called on physicians and other healthcare professionals to comply with their obligations to report adverse events. BASG made the request after reviewing the number of adverse event reports it received from the groups last year...

Welcome to our European Regulatory Roundup, our weekly overview of the top EU Regulatory news. EU Medical Device Regulations Come Into Force, Starting Multi-Year Transition Period The European Union medical device and in vitro diagnostic (IVD) regulations have come into force. The passing of the date marks the start of the phased, multi-year introductions of requirements set out in the two documents. In the immediate term, the entry of the long-gestating regu...

Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. European Commission Starts Formal Investigation into Aspen’s Cancer Drug Pricing The European Commission has opened a formal investigation into the way Aspen Pharma priced five cancer drugs. Officials began the probe after receiving reports indicating Aspen had imposed “very significant and unjustified price increases” on five off-patent cancer medicines it acquired ...

A majority of respondents to a European Commission questionnaire, including pharmaceutical and medical device companies, says health technology assessment (HTA) cooperation at the EU level should continue beyond 2020. The results, revealed in a EC report on Monday, found that almost all respondents (98%) consider it useful to compare whether new health technologies work better, equally well or worse than existing ones, as part of guidance to decision makers. Backg...

Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. EU GMP Inspectors Issued Non-Compliance Statements to 11% of Indian Sites Visited in 2016 Authorities in the European Economic Area (EEA) issued non-compliance statements to 11% of the Indian drug manufacturing plants they inspected in 2016. The rate of non-compliance is far higher than the 1% recorded globally in 2016 and the 4-6% level seen in India in the three prev...

Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. CVMP Adopts Guideline Despite Criticisms of Rising Regulatory Burden The Committee for Medicinal Products for Veterinary Use (CVMP) has adopted a guideline on the data needed to win approval for immunological minor use, minor species (MUMS) drugs. CVMP is pushing ahead with the guideline despite the animal medicine industry raising concerns it will add to regulatory bu...

Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. EMA Reveals Talks With FDA About Joint Accelerated Assessment Activities The European Medicines Agency (EMA) has revealed it is talking to its counterpart in the US about joint activities covering accelerated assessments. The subject is one of several areas in which EMA and the US Food and Drug Administration (FDA) are considering stepping up their cooperation. EMA ha...

The European Parliament on Wednesday called for an agreement to be reached “as quickly as possible” to relocate the headquarters of the European Medicines Agency (EMA) following the UK’s decision to exit the EU. The question of where to relocate the nearly 900 EMA staffers from London (EMA has already said member states will decide ) will not be an easy one, particularly as virtually every member state has requested to be the new home for the agency. Ireland, Croatia, ...

The EU's effort to overhaul the regulation of medical devices and in vitro diagnostics (IVDs) has cleared its final legislative hurdle after the European Parliament on Wednesday adopted the proposed regulations without amendment, voting down a proposal from the UK Independence Party to reject the regulations. The new regulations, which include stricter premarket review of high-risk devices, strengthened designation criteria for notified bodies, improved traceability, a...

As part of efforts to increase academia’s engagement and trust in the regulatory system, the European Medicines Agency (EMA) on Monday announced a new formal framework to better structure interactions between academia and the agency. The  framework  and action plan for the next three years were adopted by EMA’s Management Board in March and feature new ways to evaluate academic entities interested in regulatory activities, build on the available expertise to keep pace...

The eighth edition of Fundamentals of EU Regulatory Affairs will be published in December 2017. RAPS currently is seeking authors for chapters, which will be due no later than 1 August 2017. If you would like to contribute to this book, please review the list of currently available chapters below and send your CV and your preferred chapter(s) to Pam Jones, senior editor, at pjones@raps.org or submit a volunteer application online. Emails or applications must be...

Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. EMA Reports Year-Long Shortage of Bristol-Myers Kidney Transplant Drug EMA has alerted healthcare professionals to a shortage of Bristol-Myers Squibb's kidney transplant drug Nulojix. The drug shortage is set to last until the end of the year, or longer if Bristol-Myers' implementation of a new manufacturing process takes more time than anticipated. Bristol-Myers is aiming ...