EMA Outlines High-Level Strategy for Next Five Years

Regulatory NewsRegulatory News | 18 December 2015 |  By 

Antimicrobial resistance, ensuring timely access to new drugs, increasing transparency and working to harmonize more regulations worldwide are all included in the European Medicines Agency’s (EMA) strategic plan through 2020.

The new plan, unveiled Friday, offers 16 objectives around four themes: Contributing to human health, contributing to animal health and human health in relation to veterinary medicines, optimizing the operation of the network and contributing to the global regulatory network.

Human Health

Like any other regulator, one of the EMA’s top priorities is to ensure it’s prepared for public health emergencies, such as the recent Ebola outbreak and the evolving issues with antimicrobial resistance.

“With respect to antimicrobial resistance in human medicines the network will facilitate access to the market of new antibiotics particularly those against multi-drug resistant infections, and to contribute to promoting the prudent and responsible use of antibiotics,” EMA says.

In addition, the agency will explore how it can measure public health outcomes as a consequence of regulatory action.

As for the Falsified Medicines Directive (FMD), which introduced new ways to strengthen international supply chains and protect the EU from falsified medicines, the EMA says it will continue to explore how it can best address supply issues of whatever cause, including good manufacturing practice issues, disruption of manufacturing processes and reliance on a single or few manufacturers for essential medicines.

Over the next five years EMA will also look to boost the testing of centrally-authorized biologics and the official control authorities´ batch release, which are run in collaboration with the European Directorate for the Quality of Medicines & Healthcare.

And as about 75 percent of new diseases affecting humans over the past decade have been caused by pathogens originating from animals or products of animal origin, EMA says the continued emergence of new pathogens reinforces the need for a “One Health” approach between those regulating human and veterinary medicines.

Clinical Trials

The number of European clinical trials has slowed in recent years as a result of “increased competition globally and an unfavorable regulatory environment,” EMA claims, though the new EU Clinical Trials Regulation has addressed some of the regulatory issues and will take full effect by mid-2016 “at the earliest, subject to the full functionality of the IT underpinning the regulation,” EMA says.

Under the new regulation, EMA claims it will “be much easier to conduct trials in multiple Member States following a more streamlined process through a single European portal. The network will look to ensure appropriate implementation of the regulation so that it is a success. The portal and database will need to be fully functional and user friendly.

“Efforts are ongoing to bring convergence in the assessment of therapeutic added value of new medicines and patient outcomes,” EMA added. “The network will strengthen the collaboration with HTA/pricing and reimbursement bodies taking into account the discrete roles regulators and HTA/pricing and reimbursement bodies have in bringing medicines to patients.”

International Harmonization

As nearly 80% of active pharmaceutical ingredients used in medicines authorized in Europe are manufactured outside the EU, the EMA recognizes that it needs to share more information with global regulators overseeing different manufacturing stages to ensure “that the same standards are applied irrespective of manufacturing location.”

Linked to these sharing challenges is the need to ensure the integrity of data, which is what so many regulatory decisions are based on.

“Concerns about data integrity may arise for many reasons e.g. poor training, inadequate implementation or occasionally due to suspicions of falsification. The integrity of the data in the studies used to support market authorisation is fundamental to trust and confidence in the products themselves,” EMA re-iterated, noting that it’s specifically working with its partners in China and India.

In close cooperation with organizations such as WHO and EDQM, EMA will also take a lead role in the convergence of global standards through bilateral arrangements with established regulatory partners such as the US FDA and Japanese MHLW/PMDA and by participation in existing fora aimed at harmonization and convergence of approaches, such as the International Coalition of Medicines Regulatory Authorities (ICMRA), the International Pharmaceutical Regulators Forum (IPRF) and the International Generic Drug Regulators Programme (IGDRP).

EU Medicines Agencies Network Strategy to 2020


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