Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. EFPIA Warns of Insufficient Time to Move Marketing Authorizations Before Brexit A European drug trade group has warned there is too little time to move marketing authorizations before the Brexit date. The European Federation of Pharmaceutical Industries and Associations (EFPIA) wants regulators to show flexibility in the face of the anticipated time crunch facing firms...

RAPS is stepping up its presence in Europe and supporting its European expansion with the launch of its first ever RAPS European Council (REC). Following the announcement that RAPS plans to invest more than 2 million euro over the next three years to implement its growth plan in Europe, the new European Council will support RAPS’ growing member base and volunteer network across Europe with the information and education they need not only to ensure compliance with...

Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. Brexit Sparks Hiring Drive at Danish Medicines Agency The Danish Medicines Agency (DKMA) has become the latest organization to increase its hiring in response to Brexit. DKMA is taking on extra staff at its Medical Evaluation and Biostatistics (MEB) unit to bolster the new department’s ability to help the European Medicines Agency (EMA). As it stands, the department em...

Welcome to our EU Regulatory Roundup, our weekly overview of the top regulatory news in Europe. EMA Overrode Big Pharma Concerns in Adopting First-in-Human Trial Guideline An overview of comments on first-in-human trial guidance has revealed industry concerns with the draft. Merck and trade group EFPIA called out the draft for going beyond the scope of current ICH guidelines and being too prescriptive, only for the European Medicines Agency (EMA) to dismiss their worr...

Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. Medtech Industry Pressures Brexit Negotiators to Maintain Existing UK-EU Relationship Leaders from three medical device trade groups have called for the UK to retain close ties to the EU after Brexit. The letter asks negotiators on both sides of the Brexit process to keep the UK in the CE-marking regime and for its national regulatory agency to formally take part in...

Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. EU Committee Slams Plan to Cut EMA Staffing as Agency Prepares for Brexit A health committee has criticized plans to cut staffing levels at the European Medicines Agency (EMA) next year. The Committee on the Environment, Public Health and Food Safety (ENVI) said it “strongly disapproves” of the European Union’s proposal to reduce the number of EMA positions authorized ...

Welcome to our EU Regulatory Roundup, our weekly overview of the top regulatory news in Europe. UK Calls for Brexit to Have Little Impact on Regulation, Setting it on Collision Course With EU The United Kingdom government has released a paper setting out its position on issues that will affect the availability of goods after Brexit. UK politicians want many regulatory factors relevant to drugmakers to remain the same immediately after Brexit, but to achieve this goal ...

Welcome to our European Regulatory Roundup, our weekly overview of the top EU Regulatory news. Ireland Starts Consultation on Biosimilar Policy, Immediately Receives Pushback From Industry Ireland has started a consultation on how to increase access to biosimilars. The delayed document calls for feedback on pharmacy-led substitution of biosimilars, quotas for use of biologic copycats and other ways to increase uptake, although doubts remain about whether the gove...

Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. EMA Starts Consultation on Developing Drugs to Meet Needs of Older People The European Medicines Agency (EMA) is encouraging drug developers and regulators to consider the needs of older people when designing and assessing medicines and their packaging. EMA took the step to drive the development of products that cater to the difficulties some older people face when try...

Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. Drug Supply Fears Prompt Politicians to Pressure PM to Reverse Brexit Regulatory Split Politicians have begun pressuring United Kingdom Prime Minister Theresa May to reverse her decision to leave the European nuclear energy regulator. Interest in the UK’s planned exit from Euratom surged after newspapers published long-standing fears about the effect of the split on the...

Welcome to our EU Regulatory Roundup, our weekly overview of the top regulatory news in Europe. EMA Tasks Working Groups with Redistributing Regulatory Workloads in run up to Brexit The European Medicines Agency (EMA) has tasked working groups with redistributing regulatory workloads in anticipation of the United Kingdom ceasing to be a member. EMA is ordering the preparations to cut the risk of Brexit disrupting its operations or resulting in the loss of knowledge fr...

Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. ENVI Urges Commission to Exclude Healthcare From Regulation of Professions A public health committee has urged the European Commission to exclude healthcare jobs from changes to the regulation of professions. The Committee on the Environment, Public Health and Food Safety (ENVI) is worried the proposed legislation is “too complex to implement” and involves “too much re...