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 email@example.com 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.
This comprehensive resource covers product change evaluation, postmarket surveillance, audit/inspection compliance, and various other laws and regulations pertaining to maintaining a product on the market.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
Regulatory News | 24 September 2015 | By Nick Paul Taylor
Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.
Dr. Tomas Salmonson was re-elected for a second three-year term in charge of the Committee for Medicinal Products for Human Use (CHMP). Salmonson has vowed to use the rest of his time in the role to enable early access to medicines and bring the views of patients into the assessment process.
The re-election means Salmonson has until September 2018 to put these plans into action. Getting patients involved in the assessment of the risks and benefits of medicines topped the list of priorities released by Salmonson following his re-election. The move toward increased patient involvement in approval decisions has been underway at CHMP and its peers around the world for several years, but Salmonson still sees opportunities to make better use of their views.
Salmonson’s desire to step up the level of interaction between CHMP and patients is part of a broader initiative to ensure medicines that will improve health outcomes are available as soon as possible. Over the next few years, CHMP will tighten its ties to health technology assessment (HTA) bodies, which, with regulators approving lots of drugs, are now one of the main barriers to market access in Europe. Exactly how the collaboration will work is unclear.
CHMP has a fuller picture of how it intends to ensure it does not directly slow patient access to new medicines. Salmonson singled out accelerated assessment and conditional marketing authorization as mechanisms that he wants to continue to support and improve over his second three-year term. Regardless of the specific mechanism used, Salmonson is an advocate of engaging in early talks with drug developers to cut the time it takes to bring products to the patients who need them most.
The third strand of Salmonson’s agenda is the improvement of the benefit-risk methodologies in light of trends and advances elsewhere. Salmonson also wants CHMP do a better job of explaining how it reached decisions. Having been involved with approval decisions for most of the history of the European Medicines Agency (EMA), dating back to when it was still known as the European Agency for the Evaluation of Medicinal Products, Salmonson is well placed to know CHMP’s current flaws.
The Committee for Medicinal Products for Veterinary Use (CVMP) has adopted a batch of regulatory documents. A pair of guidelines, two reflection papers and a bioequivalence document have all been finalized, setting up CVMP to bring new policies into force next year.
Guidelines on what to do when a batch of a vaccine is suspected to be contaminated with bovine viral diarrhea virus will be the first to affect the industry. CVMP adopted the document this month, setting it up to come into force in March. The document is very similar to the one released for consultation in January. IFAH-Europe was the only organization to comment on the draft, and its feedback was limited to a call to make a sentence clearer and another to delete obsolete examples.
CVMP at least partly accepted both of the comments. Feedback on the second guidance document, which covers the assessment of persistent, bioaccumulative and toxic substances in veterinary medicines, was more extensive. CVMP received comments from six organizations. In a 47-page overview of the feedback, CVMP agreed to accept many of the proposed changes. The final version is now set to come into force in April.
The spate of document adoptions also included two reflection papers. While IFAH-Europe was the only organization to comment on either paper, its suggestions have triggered multiple changes to both documents. The headline change to the paper on using heat treatment to inactivate retrovirus RD114 is that its scope has been broadened to include all retroviruses. CVMP also accepted many of the comments IFAH-Europe made about its paper on the replacement of cell lines.
Officials at CVMP have also adopted a Veterinary International Conference on Harmonization (VICH) document on bioequivalence. VICH put together the document to provide a harmonized definition of bioequivalence, details of what to include in a blood level bioequivalence study report and insights into what factors to consider when designing such a study. The document is due to come into effect in Europe in August 2016.
Vaccine Guidelines, Bioaccumulation Guidelines, Retrovirus Reflection Paper, Cell Line Reflection Paper, Bioequivalence Study
EMA has updated its advice for users of the centralized procedure. The changes include tweaks to a section EMA added in March to explain what companies seeking approvals for biosimilar and generic medicines must provide to show their laboratory and trial operations comply with good practices.
Applicants now have access to templates on which they can list information to show they comply with good clinical and laboratory practices (GCP/GLP). The GCP form asks applicants to give details of any inspections, including the protocol number, title of the study, address of the trial site, date of the visit and name of the regulatory authority involved. Publication of the template clarifies exactly what GCP-related information EMA wants to receive from developers of biosimilars and generics.
The GLP template serves a similar purpose. Applicants must provide the title of the study, the date on which the final report was completed, the address of the test facility, the period in which it was used and confirmation of whether it was part of a GLP monitoring program. EMA has also updated the main centralized procedure advice document to clarify that applicants only need to file details of nonclinical studies that claim to comply with GLPs.
EMA also made a change to its post-authorization advice for users of the centralized procedure. The change affects the timeline for the translation of the annexes to CHMP opinions and Co-ordination group for Mutual recognition and Decentralised procedures – human (CMDh) positions. Marketing authorization holders (MAHs) now have six days to implement member states’ recommended changes to their translations. The previous timeline gave MAHs three days to make the changes.
Biosimilar Advice, Generic Advice, Post-Authorization Advice
CHMP has released a draft qualification opinion on the Paediatric Ulcerative Colitis Activity Index (PUCAI) for consultation. The document outlines a dialogue between an applicant and CHMP about the use of PUCAI as an endpoint in clinical trials of pediatric treatments of ulcerative colitis. CHMP is accepting comments on the draft opinion until 26 October. Draft Opinion
EMA is hosting multiple workshops to provide training on EudraVigilance. The schedule includes meetings focused on the electronic reporting of individual case safety reports in Paris, Madrid and Vienna. EMA is also hosting a training session on the EudraVigilance medicinal product dictionary in Madrid in the days before its case reporting meeting in the city. Paris, Madrid, Vienna, More
CVMP has published a draft concept paper on the production and control of allergen products for use in animals. The paper is the start of a process to bring an existing guidance document up to date with advances in understanding of the structures, cross-reactivity and stability of allergens since it was last revised in 1994. The comment period is open until the end of the year. Concept Paper
Tim Kelsey has stepped down as chair of the United Kingdom’s National Information Board (NIB) to join Telstra Health. Kelsey was the driving force behind care.data, the UK’s stuttering attempt to make more healthcare data available to drug developers and other organizations. The care.data plan was criticized extensively, leading to the ongoing delay of its implementation. Press Release
Tags: European Regulatory Roundup, EU Regulatory Roundup, Regulatory Roundup