Welcome to our new website! If this is the first time you are logging in on the new site, you will need to reset your password. Please contact us at firstname.lastname@example.org if you need assistance.
Your membership opens the door to free learning resources on demand. Check out the Member Knowledge Center for free webcasts, publications and online courses.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
RAPS recognizes that the current situation in Ukraine impacts our members and customers on many levels. If you are directly impacted by the current situation in the region and are challenged to meet your deadlines or obligations to RAPS, please reach out to email@example.com so that we can defer those challenges. Your health and safety are paramount to us.
Posted 20 November 2014 | By Nick Paul Taylor
Welcome to our European Regulatory Roundup, a new weekly overview of the top EU regulatory news.
Andreas Pott has a habit of being thrust into difficult situations. In 2010, Pott was appointed acting executive director of the European Medicines Agency (EMA) at a time when the regulator was dealing with allegations of conflicts of interest, disputes with the European Parliament and an early row over transparency. Now, Pott is once again in the hot seat during a period of turbulence at EMA.
The factors behind Pott’s latest stint as acting executive director relate to the first time he took the role. Back then, Pott held the post during the protracted and messy transition between the reigns of Thomas Lönngren and Guido Rasi. Pott handed the position over to Rasi in late 2011. However, a tribunal has now ruled the European Commission (EC) failed to follow proper recruitment procedures, triggering the annulment of Rasi’s appointment.
Having been forced to remove Rasi from his post, EMA named Pott as acting director. Pott faces the task of implementing new clinical trial legislation, managing the ongoing dispute over data transparency and getting changes to medical device regulation underway. The fallout from disputes in the EC about the oversight of EMA and the resignation of the director-general for health could also affect the regulator.
Pott has faced similar circumstances in the past. When Pott last served as acting executive director, he dealt with reports Lönngren was advising pharmaceutical companies, a request from a politician to fire an EMA expert and a spat with the Nordic Cochrane Centre over the publication of clinical trial data, the Finnegan's Take blog summarized in 2012. On that occasion, Pott held the post for one year. At this stage it is unclear how long his latest spell will last.
EMA Statement I Finnegan's Take
EMA has published a concept paper on the data requirements for veterinary medicinal products for minor uses or minor species (MUMS). The regulator lowered the data requirements for MUMS drugs almost a decade ago, but some have criticized the initiative for not going far enough.
Over the next three months, EMA is soliciting feedback from anyone with a view on the pathway for MUMS products, after which it will work on revised draft guidelines. EMA plans to publish the draft guidelines in the first quarter of 2016. Exactly what changes EMA makes will depend on the feedback it receives, but the regulator already has an idea of the areas that need updating.
EMA is focusing its attention on the two areas that developers have criticized, namely what data are needed to support MUMS products and when these reduced requirements apply. The applications of the lower data requirements to new active substances, novel technologies and first in class products are open to debate.
The MUMS document was one of two concept papers released by the Committee for Medicinal Products for Veterinary Use (CVMP) this week. CVMP also began a consultation on data requirements for drugs to stop the spread of vector-borne diseases in dogs and cats. The concept paper is the start of process to address the lack of guidance on specific study designs for such products.
MUMS Concept Paper I More
A team from the US Food and Drug Administration (FDA) has met with its counterpart in Europe in an attempt to capitalize on “renewed momentum” behind the mutual reliance agenda. The event was the first face-to-face meeting of both complete teams to discuss how EMA and FDA can collaborate on good manufacturing practice (GMP) inspections.
Representatives of FDA and Europe have spoken several times in recent months, culminating in a two-day meeting at EMA’s offices in London. The FDA’s entire mutual reliance team visited London for the event, which was also attended by EMA officials, GMP experts and representatives of the European Commission.
The goals, scope and timeline of the move toward mutual reliance were on the agenda. EMA and FDA have been working toward this point for years by extending confidentiality agreements, running joint inspections and undertaking assorted pilot programs. In May, FDA and European officials began a new phase of the mutual reliance push, leading to the meeting in London this month.
The United Kingdom government is to task an independent organization with reviewing the clinical trial process. Politicians hope the review will lead to policies that cut the time and money it takes to develop a drug in the UK. The review is set to start early next year, with the report expected to be released in the summer. Financial Times
A report from the Commission Expert Group on Rare Diseases has called for improved codification of rare diseases. The goal is to have codes for most rare diseases by the time the next edition of the International Classification of Diseases is published in 2017. Advocates of the plan predict the codes will make it easier to track rare disease patients through the healthcare system. Report
EMA's CVMP has adopted two new guidelines. A document on data requirements for changes to virus strains in authorized equine flu vaccines is set to come into force in May. CVMP also committed to adopting a Veterinary International Conference on Harmonization rule on genotoxicity testing in October. Equine Vaccine I VICH
The Committee on the Environment, Public Health and Food Safety has recommended approving the 2013 accounts of EMA, the European Centre for Disease Prevention and Control (ECDC), the European Food Safety Authority (EFSA) and the European Chemicals Agency (ECA). EMA I ECDC I EFSA I ECA
European officials have awarded CE Marks to Paragon BioTeck and IntriCon. Paragon received its CE Mark for the Comfortear Lacrisolve Absorbable Punctum Plug, while IntriCon’s clearance covers its full range of hearing aid products. Paragon I IntriCon
France’s ANSM has revealed none of the 641 women of childbearing age who have received Celgene’s thalidomide have become pregnant. The drug went on sale five years ago in France, where it is subject to particular pharmacovigilance requirements. ANSM Notice (French)
An investigation by the European Association of Hospital Pharmacists (EAHP) has found 86% of hospital pharmacists in Europe are struggling to source medicines. EAHP president Roberto Frontini has called on EMA to create a database of drug shortages. PMLiVE
EUnetHTA has released draft methodological guidelines for consultation. The document is intended to help health technology assessors evaluate the relative effectiveness of drugs and other medical products. Statement
The EC’s eHealth Network has released guidelines to help national healthcare systems recognize and deliver prescriptions made in other European countries. The document is part of a broader initiative to enable cross-border access to healthcare. Guidelines
Grünenthal has recalled five batches of Recivit sublingual tablets from the United Kingdom after discovering a possible manufacturing mix-up. Some of the blister pack cavities may contain two tablets, while others could be empty. MHRA Notice
The Committee for Medicinal Products for Human Use (CHMP) has ruled the hollow fiber system is qualified for use in tuberculosis drug development. CHMP recommended the use of the technique in preliminary proof-of-concept tests, target identification and dose selection. Draft Opinion
EMA has named Luc Vanheel as head of its administration division. Vanheel is the former director of finance and business services at the European Aviation Safety Agency. Press Release
Tags: EU Regulatory Roundup, Regulatory Roundup, European Regulatory Roundup