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

European Trade Groups Propose Criteria for Deciding New Home of EMA

European biopharma trade groups have jointly set out criteria for deciding on the new home of the European Medicines Agency (EMA). The three trade groups detailed their desire for the selection process to consider six essential criteria in a letter to a high-ranking health official at the European Commission.  

The criteria proposed by the European Federation of Pharmaceutical Industries and Associations (EFPIA), EuropaBio and Medicines for Europe are intended to minimize the risk of disruption when EMA moves from its current home in London, United Kingdom to a new location as part of Brexit. EFPIA and its co-signatories are publicly staying out of discussions about which country should host EMA post-Brexit, but through their criteria have described the type of location they want to win.

Three of the criteria relate to local regulatory capacity. With EMA currently reliant on the support of the Medicines and Healthcare Products Regulatory Agency (MHRA), the trade groups want to ensure the national regulatory agency of the new host nation is able to step up its involvement in EU-wide activities. This shift should not come at the expense of non-EMA work, the trade groups argue, and as such the local government must be prepared to increase spending. 

The remaining three criteria relate to more general characteristics of the proposed host cities. The trade groups want the commission to choose a location with easy access to an airport, transport links to the rest of the EU, adequate local hotel capacity and enough space for EMA meetings and events. Finally, the letter’s authors request the commission minimize disruption for EMA staff by factoring in the availability of international schools, labor market access and social security.

EFPIA’s criteria echo the cases made by some of the candidates to host EMA to date. Denmark, the Netherlands and other countries have talked up their regulatory and scientific capacities, and the livability of their cities for people relocating from London. If EMA is unable to persuade the vast majority of its staff to relocate from London with it, the regulator could struggle to provide normal services with its reduced headcount. The trade groups want to avoid this scenario.

As such, while the letter shies away from the debate over which city should host EMA, the criteria favor countries in western Europe that have the necessary regulatory capacity and make it easier for staff to decide to relocate. 

The organizations made their case in a letter to Xavier Prats Monné, the director general of the Directorate-General for Health and Food Safety. Responsibility for choosing a new site for EMA will fall on Monné and the rest of the commission. Officials are yet to propose a timeline for making the decision, but many people affected by the relocation want clarity this year.

Letter

EMA Shares Guideline on Risk to Human Health of Veterinary Drugs in Groundwater

EMA has released a guideline on the toxicological risk veterinary medicines in groundwater pose to human health. The text proposes a methodology for assessing whether the concentration of a drug in groundwater constitutes a risk to the health of humans who drink the contaminated liquid.

Today, regulators view concentrations above 0.1 µg/l as unacceptable. At lower concentrations, no risk is anticipated and, as such, no regulatory action is required. However, EMA is now considering whether this is the right approach.

The 0.1 µg/l cutoff point was derived from the detection limit of analytical methods at the time. Development of more sensitive tests capable of detecting small quantities of contaminants has made a new approach possible. As there is evidence some drugs can do harm at levels below 0.1 µg/l, EMA thinks there is value in using these new, more sensitive tests to make more informed judgements about the risks posed by groundwater contamination.

EMA is proposing the industry use two formulas that factor in the acceptable daily intake of an active ingredient, daily consumption of drinking water, predicted concentration in groundwater and other variables to rule whether the risk to human health is acceptable. If the predicted concentration in groundwater exceeds the maximum tolerable concentration in drinking water, the risk to human health will be deemed unacceptable.

The human health formulas are accompanied by other calculations for assessing the risk a drug poses to groundwater ecosystems. EMA has given the industry until the end of August to comment on the draft.

Draft Guideline

CVMP Floats Revisions to Surveillance of Eudravigilance Veterinary Data

EMA’s Committee for Medicinal Products for Veterinary Use (CVMP) is planning to change its recommendation for the basic surveillance of Eudravigilance Veterinary (EVVet) data. CVMP wants to make the revisions to improve pharmacovigilance surveillance by integrating the evaluation of periodic safety update reports (PSURs) into the process.

The committee began work on revisions to its original recommendation about basic surveillance within months of the adoption of a related pharmacovigilance document in 2015. CVMP felt the revision was needed to avoid overlap and discrepancies between the two texts. This led to the publication of recommendations that seek to improve surveillance principles and clear marketing authorization holders (MAHs) to simplify PSUR content.

CVMP is proposing to allow MAHs to skip the provision of a line listing in certain circumstances, and not attach the summary of product characteristics to the PSUR. The proposals are part of an attempt to avoid wasted effort by adopting a risk-based approach to PSURs and their content.

EMA is accepting feedback on the proposals until the end of August, beyond which it plans to see how the new way of working functions in the real world.

“The revised recommendation will be trialled initially in a pilot phase. Based on the experience gained and as the supporting electronic systems are developed further, as necessary, implementation of the revised recommendation is expected for all [centrally authorized products]. It is envisaged that the recommendation will be reviewed within a few years in light of the experience gained following implementation,” CVMP wrote in its recommendation.

Draft Recommendation

Czech Republic Establishes Guidelines for Sharing Trade Secrets with Authorities

The State Institute for Drug Control (SUKL) of the Czech Republic has established guidelines for the submission of trade secrets to authorities. SUKL created the advice to help companies identify documents that contain trade secrets when submitting files to support reimbursement decisions.

Applicants are advised to clearly mark any files or emails that contain trade secrets. SUKL also wants companies to refer to the documents that contain trade secrets in their accompanying letters and tick the appropriate box on the application form to alert the receiver to the presence of sensitive materials.

When a document contains a mix of classified and publicly available information, SUKL wants companies to submit two versions, one complete copy and another with the trade secrets redacted.

SUKL thinks the guidelines will ensure authorities can access the information they need to make pricing and reimbursement decisions without compromising trade secrets. 

SUKL Notice (Czech)

Other News:

EMA has released a draft guideline on the assessment and control of mutagenic impurities in veterinary medicinal products. The text details how to characterize the risk of a product, steps that can be taken to control threats and considerations for authorized products. Draft Guideline