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Focus on Regulation

EMA seeks to support the use of patient registries and to improve dialogue between various stakeholders

 

In September 2015, the European Medicines Agency (EMA) launched the initiative for patient registries. The purpose of the initiative is to improve the benefit-risk evaluation of medicinal products for human use. The EMA’s initiative for patient registries focuses mainly on the ways in which existing patient registries could be improved. This could be systematically considered by regulators and pharmaceutical companies when collecting regulatory data.

EMA’s initiative for patient registries

A patient registry is defined on the EMA website as:

“an organized system that uses observational methods to collect uniform data on a population defined by a particular disease, condition, or exposure, and that is followed over time”.

Considering the barriers, such as absence of harmonized protocols, that drug companies and regulators confront while using current registries, or developing new registries, the EMA’s initiative aims to promote the use of patient registries and optimize stakeholder collaboration. EMA mainly seeks to develop dialogue among registry holders, registry coordinators and potential users of registry data at early stages of the marketing authorization process.

In October 2016, EMA held a workshop to identify the challenges and obstacles arising during stakeholders’ collaboration. In its effort to support stakeholders and regulators, EMA will consider the recommendations derived from the workshop. EMA will, among other things, explore mechanisms for pharmaceutical companies and regulators to systematically consider the necessity for patient registries and collaboration with registry holders. Furthermore, EMA will promote the distribution and circulation of information related to specific diseases.

Although the exact ways, in which the dialogue will be improved is not clear yet the EMA will release an updated mandate and strategy for its initiative by the end of the second quarter of 2017.

 

EFPIA’s Suggestions

The European Federation of Pharmaceutical Industries and Associations (EFPIA) has argued that, although the use of patient registries could be of considerable value during the marketing authorisation process, there are still obstacles to be overcome.

EFPIA has made some suggestions with regard to the steps that could be followed to improve patient registries. EFPIA has recommended the appropriate and unceasing update of patient registries to develop patient registries that will be valuable research platforms.

Other EFPIA suggestions involve:

  • the coordination of national and international current registry initiatives;
  • the harmonization of protocols, scientific methods and data structures;
  • the connection of registries of new medicinal products through international networks; and
  • the establishment of registries easily accessible by researchers.