Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.

Dutch Regulator Overhauls Policy on Nomenclature of Medicines

The Medicines Evaluation Board (MEB) in the Netherlands has completely revised its policy on nomenclature covering human medicinal products and is enforcing the changes with immediate effect.

Out of all the revisions included in the new nomenclature policy, MEB has picked out six that it sees as the most important. The list is topped by an explanation of how MEB defines and distinguishes between the terms “product name” and “nomenclature.” MEB sees “product name” as being limited to the invented brand or scientific title, plus the identity of the producer. In contrast, “nomenclature” also covers the strength, dosage form and, when needed, the active ingredient.  

Other changes to the document include the removal of two requirements. Companies no longer need to list the salt form in the name, apart from when it is relevant to the product. However, the salt form must still be listed on the packaging in order for a product to be compliant with the terms set out by EMA’s Working Group on Quality Review of Documents (QRD). MEB has also dropped its dedicated paper on “umbrella brands,” the content of which is included in the nomenclature text.

MEB is advising companies to state the full pharmaceutical form as set out by the European Directorate for the Quality of Medicines & HealthCare (EDQM), too. The remaining changes highlighted by MEB include amendments to the policy for combination packages and the need to include abbreviated indications in the product names of over-the-counter drugs. MEB decided on the changes after consulting with pharma companies and other interested parties.

MEB Notice

CHMP Calls on PK/PD Experts to Discuss Pradaxa, Other Anticoagulants

The Committee for Medicinal Products for Human Use (CHMP) and other units of EMA are calling for experts to discuss the role of pharmacokinetic and pharmacodynamic (PK/PD) assessments in the use of Pradaxa and other direct oral anticoagulants (DOACs).

CHMP is to hold a meeting on the topic next month in an attempt to improve its understanding of the problems associated with the clinical use of DOACs and what can be done to improve decision making. DOACs, notably Boehringer Ingelheim’s Pradaxa, have faced regulatory scrutiny because of reported links to serious bleeding events. Concerns about such risks and how to allay them are part of the agenda for the meeting.

Regulatory officials are particularly interested in the handling of subpopulations that have a higher risk of bleeding and individuals who suffer such adverse events. The adjustment of the dose during routine use or following a bleeding event has been suggested as a way to manage the risk, although this is a contentious topic. CHMP wants to bring rigor to the discussion by identifying gaps in understanding of the PK/PD of DOACs and research programs that can improve the situation.

Officials from CHMP, EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) and the United States Food and Drug Administration (FDA) are expected to attend the event. EMA has also invited academics, physicians, patient representatives and members of the pharmaceutical industry. The agenda includes a time slot in which manufacturers of DOACs will have an opportunity to talk.

EMA Notice, Agenda

EMA Starts Revision Process for 10-Year-Old Herbal Monograph Guidelines

EMA’s Monograph and List Working Party (MLWP) has released a draft concept paper outlining its plan to revise guidelines on the preparation of monographs for traditional herbal medicines. MLWP wants to update the text to reflect advances, as well as shifts in practice and legal interpretations, that have taken place since the publication of the guidelines.

The update is, on one level, intended to bring the guideline up to date with general current practice at MLWP and the Committee on Herbal Medicinal Products (HMPC), but the working group has more specific intentions, too. Since the original guideline document was published in 2006, the release of a legal interpretation by the European Commission has prompted HMPC to post a statement about the indications in which traditional herbal medicines can be used.

HMPC’s statement referred to indications that are acceptable “after exclusion of serious conditions by a medical doctor.” The plan is to update the guideline with this information. HMPC also wants to include the list of study characteristics it released last year as part of guidance notes on how to develop uniform assessment reports. The third specific concern raised by HMPC relates to pediatric patients and other subpopulations. HMPC wants the text to cover the requirements of such groups.

The plan is to have revised draft guidelines ready for release for public consultation by the third quarter of next year, setting MLWP up to publish the final text within nine months of the end of the external comment process. Before that happens, MLWP is canvassing opinion on what should go into the draft guidelines. The concept paper is open for comment until the end of January. 

Concept Paper

EMA Reports Year-on-Year Drop in Veterinary Antibiotic Sales

The European Medicines Agency (EMA) has reported a year-on-year decline of sales of veterinary antibiotics across the region. Yet while the overall data suggest efforts to curb the use of antibiotics are taking effect, performance from country to country is inconsistent, with some nations posting double-digit increases in sales.

Out of the 23 European Union countries involved with the project, six reported an increase in sales of antibiotics for use in animals of more than 5%. The largest national increase reported was 21%. These rises were offset by activity across the rest of Europe, where 11 countries posted declines in sales of 5% or more. The largest decline in sales in any country was 51%. While the overall trend is positive for those trying to curb antibiotic use, the data do more than just confirm Europe is on track.

“With the new data collected and experience gained in the process, we are getting a clearer picture of the sales of antibiotics in animals in Europe,” David Mackay, head of veterinary medicine at EMA, said. “We hope they can support European countries in promoting rational use of antibiotics in animals. Collecting accurate data on the sale and use of these medicines in food-producing animals is an essential step to inform policies for responsible use of antibiotics.”

The data were gathered as part of the European Surveillance of Veterinary Antimicrobial Consumption (ESVAC) project, which has now released five reports about sales of such products. With ESVAC now possessing data going back to 2005, the initiative has put together an interactive database to make the resource more accessible and useful. EMA thinks the database will allow users to focus on data of interest to them, whether they are about a specific country or certain antibiotic.

Press Release, ESVAC Report, Database

Other News:

EMA is holding a workshop on the upcoming International Conference on Harmonisation (ICH) Q12 guideline. The meeting will enable EMA to gather feedback on what the groups it regulates expect from ICH Q12, which is intended to create a framework for managing post-approval changes to chemistry, manufacturing and controls. EMA Notice

Regulators and industry representatives are scheduled to meet again to discuss the workings of the centralized procedure. EMA is holding the invite-only meeting in an attempt to improve the process. EMA Alert