EMA publishes report on making Article 58 and other EMA outputs more relevant for non-EU regulators

Access to medicines is an issue for patients across the world, and the ability to monitor and oversee medicines in use are common issues facing public health authorities and regulators across the globe. So, the European Medicines Agency (EMA), working with the Maltese presidency of the EU, convened a meeting of regulators from the EU and Africa, earlier this year to discuss EMA procedures and role in facilitating access to medicines. The meeting was attended by EMA CHMP members, experts and staff, African national regulatory authorities, the African Union NEPAD agency, the World Health Organization (WHO) and the World Bank. The workshop was financially supported by the Bill & Melinda Gates Foundation.

The objectives of the meeting were to:

  • Increase awareness and understanding of the Article 58 procedure, and other EMA reliance and collaborative procedures and initiatives
  • Increase awareness and understanding of specific needs of African regulators, in both the preapproval and post-approval/pharmacovigilance areas
  • Identify specific proposals to improve procedures to enable target regulators to increase reliance and use of EMA/CHMP work medicines.

The report describes ways in which Article 58 applications and the associated CHMP assessment reports could be improved to support access to medicines for patients in non-EU countries.  For example, actions points include making the WHO Quality Information Summary a standard part of assessment reports and adapting risk management plans for medicines going through Article 58.  It is suggested that, following CHMP opinion, there could be systematic exchanges between the committee and target country authorities for Article 58 medicines and candidate medicines for the WHO collaborative registration procedures to facilitate national registration decisions.  In fact, there is a more general theme of a desire to improve communication flows between EMA, WHO and non-EU regulatory authorities.

It is worth noting that potential sponsors of Article 58 medicines can obtain scientific advice, something which experts and regulators from target countries will be more involved in at the earliest possible stage of development.  Interestingly, there was an action identified for the EMA to review the conduct of CHMP and SAG meetings for Article 58 medicines to facilitate input from WHO and target country experts and regulators.  The EMA will also be reminding sponsors that Article 58 medicines can be considered for support under PRIME, the agency’s priority medicines initiative.

Click here to access the report.