European Regulatory Roundup: EU Trade Groups Propose

European Regulatory Roundup: EU Trade Groups Propose Criteria for Deciding EMA’s New Home (2 March 2017)

European business groups propose criteria for deciding the new EMA home

European biopharmaceutical groups have jointly defined the criteria for deciding the new home of the European Medicines Agency (EMA). The three trade groups have detailed their desire that the selection process takes into account six key criteria in a letter to a senior European health official.

The criteria proposed by the European Federation of Pharmaceutical Industries and Associations (EFPIA), EuropaBio and Medicines for Europe aim to minimize the risk of disruption when EMA moved to its present headquarters in London, UK, to join Brexit. EFPIA and its co-signatories are publicly out of the discussions about the country that could host EMA post-Brexit, but according to their criteria they describe the type of place they want to win.

Three of the criteria relate to local regulatory capacity. EMA, with the support of the Medicines and Health Products Regulatory Agency (MHRA), business groups want to ensure that the national regulatory agency of the new host country can strengthen their participation in EU activities. This change should not detract from non-EMA workforce, business groups argue, and as such, the local government must be prepared to increase spending.

The three remaining criteria relate to the more general characteristics of the proposed sites. Commercial groups want the Commission to choose a location with easy access to the airport, communicated with the rest of the EU, adequate local hotel capacity and enough space for EMA meetings and events. Finally, the authors of the letter to the Commission to minimize disruption of personal EMA taking into account the availability of international schools, access to labor markets and social security.

The EFPIA criteria echo the cases submitted by some candidates to host the EMA to date. Denmark, the Netherlands and other countries have talked about their regulatory and scientific capacity and the viability of their cities for people traveling to London. If the EMA fails to convince the vast majority of its staff to move to London with him, the regulator could have trouble providing normal services to its small size. Business groups want to avoid that scenario.

As such, while the letter out of the debate on the city that will host the EMA criteria favor the countries of Western Europe that have the necessary regulatory capacity and facilitate resettlement.

The organizations argued their views in a letter to Xavier Prats Monné, Director General of Health and Food Safety Directorate-General. The responsibility to choose a new site for the responsibility of EMA Monne and the rest of the commission. Officials have yet to come up with a timetable to make the decision, but many people affected by resettlement want clarity this year.

Letter

EMA sharing guidelines on the risks to human health of veterinary medicinal products in groundwater

EMA has issued a directive on the toxicological risk that veterinary medicinal products in groundwater pose to human health. The text proposes a methodology to assess whether the concentration of drug in groundwater poses a risk to the health of humans who drink the contaminated liquid.

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

The cut-off point of 0.1 g / l is obtained from the limit of detection of the analytical methods at the moment. The development of more sensitive tests can detect small amounts of contaminants has made possible a new approach. Because some drugs may affect concentrations below 0.1 mg / l, EMA believes that using these new, more sensitive tests is useful in making more informed judgments about the risks of groundwater contamination.

The EMA provides the industry uses two formulas that take into account the acceptable daily intake of an active ingredient, the daily consumption of drinking water, the expected concentration in the groundwater and other variables to determine if the risk to human health is acceptable . If the expected concentration in surface waters exceeds