European Regulatory Roundup: European Regulators, Industry Focused on New Trade Agreement (26 March 2015)

Regulatory NewsRegulatory News
| 26 March 2015 | By Nick Paul TaylorMichael Mezher 

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

Industry, Regulators Back TTIP as Ninth Round of Negotiations Nears

Regulators and industry representatives have met to discuss the Transatlantic Trade and Investment Partnership (TTIP) ahead of the ninth round of negotiations about the controversial deal. While many have concerns about TTIP, regulators on both sides of the Atlantic expressed enthusiasm for the plan.

Differences in the regulation of medical products and the systems that use them in the United States and Europe have put healthcare at the forefront of concerns about TTIP. Such concerns mean that while other sectors are looking at mutual recognition of approval decisions, the goals in healthcare are more modest. The first step is to establish a way to share confidential information, starting with details of inspections and later expanding to cover clinical trials. 

Overcoming the confidentiality barriers to such sharing would move resource-constrained regulators closer to the long-discussed benefits of transatlantic cooperation. “Some of the benefits will be that we can better concentrate our resources to provide oversight of medical products. If we can rely on other regulatory counterparts then it helps us to better use our resources,” Donald Prater, acting director of the US Food and Drug Administration (FDA) Europe Office, said at a meeting attended by EurActiv.

Representatives of Amgen and the European Generic Medicines Association also talked up the benefits of TTIP, the latter of which called the establishment of a legal framework for data sharing “a huge step and really significant.” Further TTIP negotiations are scheduled for next month. – Nick Paul Taylor


What do Regulatory Pros Need to Know About Personalized Medicines and Companion Diagnostics in the EU?

The shift from “one size fits all” medicinal products to more targeted and customized drugs is introducing new challenges for the people involved in the development and commercialization of such products.

One of those challenges: Knowing how to bring your personalized medicine product to market. Want to learn how? Attend this upcoming RAPS workshop and hear from experts and EMA regulators involved in the regulation of personalized medicine. Register by 11 May 2015 to attend this essential event. [Read More...]

Trade Groups Call for Urgent Improvements to EU Device Regulations

Diabetes trade groups on both sides of the Atlantic have called for urgent improvements to European regulations covering insulin pumps. The trade groups issued the statement after identifying significant and concerning differences between the approaches of EU regulators and FDA.

The European Association for the Study of Diabetes and the American Diabetes Association joined together to analyze the situation and publish the resulting statement. Many of the recommendations relate to the harmonization of regulations, but the authors think more notable and urgent changes are needed in Europe than the US.

Writing in the journal Diabetologia, the authors note the lack of a publicly accessible database of medical device adverse events in Europe makes it impossible to assess the post-approval safety profiles of insulin pumps. As FDA already has such a database, the trade groups recommend Europe should use this as the basis for a global repository of adverse event reports.

The creation of such a database is one of three recommendations for the regulators. EU regulators and FDA are also asked to harmonize pre- and post-marketing standards for manufacturers of insulin pumps, as well as publish an annual summary of their regulatory activities. Such a resource would advance the trade groups’ agenda to strengthen “meknovigilance,” the device equivalent of pharmacovigilance. – Nick Paul Taylor

Diabetologia, Pharmaceutical Journal

BfArM President Shares Concerns Over Medical Apps

Germany’s regulator, the Federal Institute for Drugs and Medical Devices (BfArM) is anticipating an increase in issues related to medical apps in the near future. Apotheke Adhoc reports the agency is already seeing reports related to medical apps. Though Germany has strict standards for healthcare products, the country does not currently regulate such apps.

Speaking at a symposium in Bonn, BfArM President Karl Broich said use of these apps carries risk of misdiagnosis. Additionally, the agency is concerned that patient privacy may be at risk, and says the legal framework for storing and transmitting such data needs to be established. – Michael Mezher

Apotheke Adhoc

Calls for Participants in New Antimicrobial Resistance Project

A project aimed at identifying new antimicrobial agents to replace existing therapies is asking clinical trials in Europe to join its efforts. The project, COMBACTE-CARE, is part of the Innovative Medicines Initiative’s (IMI) New Drugs 4 Bad Bugs (ND4BB) program.

COMBACTE-CARE has received 83 million EUR in funding to conduct a 5-year project to better determine how cases of carbapenem-resistant enterobacteriaceae (CRE) are handled. The project also aims to develop new tools for detecting CRE. – Michael Mezher

Press Release, Open Call

Irish Regulator Conducts Inspection in Egypt, Plans for Future Fee-Based Work

The Irish Medical Times reports that Ireland’s regulator, the Health Products Regulatory Authority (HPRA), which conducted a single site inspection in Egypt in 2014, will continue its operations in the country in the future.

HPRA said it entered into an agreement with Egypt’s Ministry of Health in 2012, but due to instability in the country was not able to carry out the bulk of the work. The agency said it is considering conducting further inspection work abroad as a potential revenue stream. The regulator currently conducts inspections for companies importing products into Ireland and the EU, but sees opportunity in lending its expertise in regions such as Asia and the Middle East. – Michael Mezher

Irish Medical TImes

CVMP Pushes for Increased Reporting of Adverse Events

A working party of the Committee for Medicinal Products for Veterinary Use (CVMP) has proposed ways in which member states can correct the under-reporting of adverse events in food-producing animals.

CVMP made the suggestions after noting a possible discrepancy in adverse event reporting. While drugs for use in food-producing animals account for more than half of all approved products, this group generated just 13% of the adverse events reported in 2013. CVMP has tried to increase the rate of pharmacovigilance reporting for a decade, but is still dissatisfied with the situation.

The latest attempt to correct under-reporting is a reflection paper aimed at European countries. In the paper, CVMP suggests countries should provide feedback to people who report adverse events. However, cookie-cutter feedback is thought to be ineffective, and it may be impossible to provide detailed comments to everyone. CVMP proposes an annual summary as a compromise.

Other proposals include the simplification of the reporting process, the integration of veterinary medical journal software with pharmacovigilance systems and the development of mobile apps. CVMP also posted a reflection paper on poorly extractable and non-radiolabeled substances, in which it outlines how to manage the development of medicines that are difficult to remove from the soil. – Nick Paul Taylor

Reflection Paper I More

Public Private Partnership to Deliver Innovative Prenatal Test to UK Patients

The UK’s National Health Service (NHS) has announced a partnership with Premaitha Health Plc to establish a UK Centre of Excellence for Prenatal Screening at St George’s University Hospital. Premaitha will provide its non-invasive prenatal test (NIPT) IONA, the first in-vitro diagnostic of its kind to receive CE-marking. IONA is intended to screen fetuses for genetic diseases such as Down syndrome.

NIPTs are said to be more accurate than other screening methods and give fewer false positives. Prior to the partnership with Premaitha, NIPTs were only available to women in the UK by mailing samples to the US or China. – Michael Mezher

EMA Posts Draft Guidelines on Tick and Flea Treatments

The European Medicines Agency (EMA) has released draft guidelines on assessing the efficacy of tick and flea drugs for cats and dogs. Medicines to both prevent and treat infestations, as well as those that have insect growth regulating properties (IGRs), are covered by the guidelines.

EMA’s CVMP breaks the process of testing for efficacy down into four steps, the first of which is describing the mode of action. Once this is done, developers can advance to determining the dose and then on to the third step, confirming the regimen in trials. Finally, clinical field trials are needed. The development plan is a mix of laboratory studies and confirmatory field trials.

In the laboratory study section, CVMP goes into detail about topics such as the level of infestation — 50 unfed adults in a 50:50 sex ratio — and the various measures of efficacy. The less controlled nature of field studies means CVMP devotes fewer words to this section, limiting itself to explanations of the number and type of animals that should be included in the study and when to count their ticks.

IGRs are considered important enough to occupy a dedicated and lengthy section. Such treatments work by inhibiting the development of young fleas and are considered to carry a lower risk of resistance than broad-spectrum insecticides. – Nick Paul Taylor

Draft Guidelines

Other News:

The CVMP Ad Hoc Group on Veterinary Novel Therapies has released its work plan for 2015. Q&A documents covering cell-based products, monoclonal antibodies and cancer vaccines are all on the agenda. The need for such documents follows growing interest in developing stem cell treatments and other novel therapies for use in animals. CVMP Work Plan

EMA Deputy Executive Director Andreas Pott has written a letter of support for skeletal muscle injury biomarkers, in which he calls for further research into four plasma or serum proteins. The letter follows a request from the Predictive Safety Testing Consortium for scientific advice regarding novel biomarkers of drug-induced skeletal muscle injury and a subsequent EMA meeting. Letter

The United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) is looking for two people to join its advisory board on the registration of homeopathic products. MHRA is specifically looking for community pharmacists with an interest in homeopathy and people who want to become a lay member. The board holds approximately six meetings a year. MHRA Notice

EMA has elected the head of the Austrian Medicines and Medical Devices Agency, Dr. Christa Wirthumer-Hoche, as its vice chair. Wirthumer-Hoche, who replaces the retiring Dr Walter Schwerdtfeger, will serve a three-year term. The board meeting also discussed the need to improve the regulatory environment for advanced therapies. Press Release

The United Kingdom’s National Institute for Health and Care Excellence (NICE) has posted three final guidance documents. The watchdog found Boehringer Ingelheim’s type II diabetes drug Jardiance and Norgine’s  overt hepatic encephalopathy treatment Targaxan both met its cost-effectiveness criteria. However, Celgene’s multiple myeloma treatment Imnovid was rejected by NICE. PharmaTimes

The European Pharmacopoeia Commission has endorsed a strategy to implement the International Conference on Harmonisation (ICH) Q3D guideline on elemental impurities. Q3D was adopted by ICH in December 2014, and now awaits implementation by ICH members. The guideline is designed to set standards on the amount of metal impurities in medicines.

Fourteen European countriessigned the Council of Europe convention against Trafficking in Human Organs on 25 March 2015 in Santiago de Compostela, Spain. The treaty is the first to address organ trafficking on an international level and was signed by Albania, Austria, Belgium, the Czech Republic, Greece, Italy, Luxembourg, Norway, the Republic of Moldova, Poland, Portugal, Spain, Turkey and the UK. The Council of Europe welcomes any and all countries to join the treaty.

In light of World Tuberculosis Day, the European Centre for Disease Prevention and Control and the World Health Organization (WHO) issued a joint press release on tuberculosis. According to the release, about 1,000 people developed tuberculosis per day in Europe. The number of cases is in decline, with 6% fewer cases than in 2012.

Sweden’s National Veterinary Institute has confirmed that two swans found dead in Stockholm carried the H5N8 bird flu strain. The Swedish Board of Agriculture is not recommending any additional precautions, and the country’s Public Health Agency advised that this particular strain has not made the jump to humans.

Janssen Pharmaceuticals has launched an interactive web application called the EU Disease Lens, which provides information such as prevalence and the number of products in development for 15 diseases that impact European patients. The site allows for country by country breakdowns of prevalence data sourced from the World Health Organization. The EU Disease Lens is available free to the public.


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