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

EMA Maps International Regulatory Coordination Initiatives to Show Overlaps, Gaps

The European Medicines Agency (EMA) has mapped cooperative regulatory initiatives to better understand how and where international peers are working together. EMA found there were a “myriad of initiatives but no strategic coordination,” prompting it to warn regulators are duplicating efforts in some areas while overlooking other fields altogether.

Officials at EMA put together the report as part of their involvement in the International Coalition of Medicines Regulatory Authorities (ICMRA), an organization established to provide direction for common activities. Before ICMRA can provide such direction, it first needs to know how agencies are cooperating currently. Equipped with this knowledge, the coalition will be better placed to decide where it should focus its energy. The report suggests ICMRA has plenty of work to do to improve the situation.   

“Mappings and analyses strongly support the need for a global strategy to support cooperation between international medicines regulators, to help avoid an overlap of activities and make resources available for areas where gaps still exist,” EMA wrote in its report.

EMA looked closely at three key areas of cooperation: supply-chain integrity, pharmacovigilance and crisis management. The agency identified ways to improve cooperation in each area.

The globalization of supply chains and the quality risks this creates have made their integrity a big area for international cooperation. In mapping these initiatives, EMA identified multiple areas of overlap, including databases, track and trace initiatives, alert systems and ways to ensure “single points of contact.” EMA also found a lack of mutual awareness and the inability to link different systems. Faced with this situation, the authors see value in trying to globalize track and trace systems and link databases and alert systems across borders.

EMA found a similar lack of mutual awareness and inability to link projects when it reviewed pharmacovigilance projects. The authors focused their review of cooperation in pharmacovigilance on the lack of projects using “big data technologies” to produce “a huge amount of post-marketing data” and create better predictive models. Overall, the authors see value in establishing “a more globally connected pharmacovigilance system,” but note data protection legislation and the current lack of coordination will make this a challenge.

Cooperation in the final focus area of the report, crisis management, is hamstrung by a “lack of common understanding among regulators of what a health crisis means,” according to the EMA authors. EMA has proposed a definition so international regulators can work together more effectively when safety issues, crisis-driven shortages and emerging health threats require more than routine measures to bring under control.

EMA Report

UK Starts Consultation on Creation of Biologic Quality Standards

The United Kingdom Medicines and Healthcare Products Regulatory Agency (MHRA) is seeking feedback on its strategy for the creation of pharmacopeial public quality standards for biological medicines. Officials want to know how standards can help current and future products, how they can best work with the industry to establish norms and what areas are missing from the draft text.

MHRA published the document in response to the forecast rise in biologics, including Advanced Therapy Medicinal Products. With such products expected to account for a growing slice of healthcare budgets, MHRA wants to be “the early adopter and driver of new and innovative approaches in standards setting for biological medicines.” The regulator sees this as the best way to ensure its approach to biologics meets its broader ambitions to enable innovation and secure global supply chains.

To work toward these goals, MHRA has set out a five-year strategy for biological pharmacopeial standards. The first step is to compare its current approach to the development of monographs for biologics to alternative procedures. MHRA also plans to identify gaps and weaknesses in its current portfolio of standards. In doing so, MHRA will draw on its data and understanding of stakeholder needs. The strategy also calls for MHRA to bolster its understanding of such needs, specifically by tightening ties to industry and gaining knowledge of how manufacturers control product quality.

MHRA wants to leverage its knowledge and ties to develop pilot projects that explore potential solutions to quality problems faced by it and the industry it regulates. The agency plans to use its “ability to be a fast and adaptable organization” to drive forward exploration of alternative approaches to pharmacopeial control of biological quality.

These activities will require MHRA and its standards setting units — the National Institute for Biological Standards and Control and British Pharmacopoeia — to pool their resources. MHRA hopes to work similarly closely with its international peers to drive adoption of best practices.

The agency is accepting feedback on the draft until 10 April.

MHRA Notice

Germany Introduces ‘Blue Hand’ Logo to Official Training Materials

The German Federal Institute for Drugs and Medical Devices (BfArM) has introduced a “blue hand” logo to designate official training materials. BfArM adopted the logo to cut the risk of healthcare professionals mistaking the materials for advertising and failing to take on board their messages.

This risk is real. In its explanation of the need for the logo, BfArM cites a case of medical specialists overlooking materials explaining a change in the potency of a product because they thought the letter was advertising. This led to some patients suffering side effects after receiving too much of the new, more potent formulation.

BfArM thinks it can prevent such confusion by adding a blue hand logo to officially approved training materials. The logo takes its inspiration from the red hand symbol carried by envelopes and letters containing details of previously unknown severe adverse reactions or a change to the indication of a product. On training materials, the hand will be the color blue, not red.

All training materials must now carry the blue hand logo to differentiate them from other, less health-critical materials distributed by pharmaceutical companies. BfArM brought in the requirement last month but only alerted the industry through a press release this week.

BfArM Release (German)

EMA Schedules Pediatric Cancer Workshop

EMA has scheduled a workshop on the unmet therapeutic needs of children with cancer for later this month. The event will discuss topics including the biology of anaplastic lymphoma kinase (ALK) in pediatric cancer.

ALK occurs across a range of cancers, but in small numbers. For this and other reasons, ALK and some other aberrations pose challenges to researchers trying to develop drugs for use in pediatric populations. EMA and ACCELERATE, a group focused on speeding the advance of medicines to treat pediatric cancers, plan to discuss these issues at the workshop and give industry and academic groups a chance to share data on ALK inhibition.

The agenda also includes time to discuss the challenge of developing drugs against particular types of pediatric cancer. inflammatory myofibroblastic tumor, rhabdomyosarcoma, anaplastic large cell lymphoma and neuroblastoma are all on the agenda.   

EMA and ACCELERATE have scheduled the workshop for 30 and 31 January.

EMA Notice

Other News:

MHRA has issued a Class 4 caution after Bayer told it about a potential problem with Mirena inserters. Bayer contacted MHRA after receiving two complaints about Mirena products with the insertion tube mounted inversely to the handle. This could lead to the device being inserted at the wrong depth, potentially leading to adverse events or reduced efficacy. MHRA Notice