EU Regulators Reveal 'Strategy to 2020'

Regulatory NewsRegulatory News | 31 March 2015 |  By 

European medicines regulators are asking for feedback on a newly released plan intended to lay out the European Medicines Agency (EMA) and the Heads of Medicines Agencies’ (HMA) strategic direction for the next five years.

Areas of Focus

This is the first time EMA and HMA will be guided by a single strategy document. In previous years, EMA and HMA released individual strategies which, while meant to be consistent and complimentary, had differences in priorities and work areas.

The regulators say the new strategy document, EU Medicines Agencies Network Strategy to 2020, will help strengthen collaboration and will be critical to meeting the public health challenges they are charged with addressing in relation to:

  • human health
  • animal health and human health in relation to veterinary medicines
  • optimizing the operation of the network
  • the global regulatory environment

In each of these work areas, the agencies identify four objectives to work toward in the coming years.

Collaboration and Efficiency

The goals of EMA and the various national regulatory authorities are highly interconnected. Because their work often overlaps, it is critical that the various agencies operate and communicate efficiently.

To do so, the agencies say they will need to ensure access to “inter-operable IT services,” and work to reduce administrative burdens in ways that will not impact patients.

The agencies also recognize that effective communication both within the EU medicines agencies network and externally to patients, industry and payers will help foster trust and improve access to medicines.

International Efforts

The strategy document also outlines the EU medicines agencies’ contributions to the global regulatory environment. The agencies will continue to expand their participation in international initiatives such as the International Conference on Harmonization (ICH) and the Pharmaceutical Inspection Co-Operation Scheme (PIC/S).

In light of an increasingly global pharmaceuticals industry, the network will look at developing its relationships with regulators in China and India. The agencies also will look at ways they can assist regulators in developing regions.

Human Health

Under the banner of human health, the agencies identify several priority issues they will attempt to address through their efforts through 2020, including the threat of antimicrobial resistance, meeting the needs of “special populations” such as children and patients who suffer from rare diseases and responsiveness of public health authorities in the face of epidemics. The agencies will also continue their efforts to increase access to new medicines through programs such as EMA’s adaptive pathways pilot project.

Another major objective outlined in the document is to “strengthen regulatory capability and transparency.” In order to keep on top of scientific developments, the agencies will work to develop their personnel and “work more closely with the academic community, industry and others to ensure appropriate support is given.”

The agencies say that they have made considerable developments in making their work more transparent, but will continue to refine their efforts to make information public while protecting personal data and commercially confidential information.


EU Medicines Agencies Network Strategy to 2020


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