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EMA experts meet with African regulators to discuss opportunities for collaboration

How to improve the availability of high quality, safe and effective medicines to patients in countries beyond Europe and how to make better use of existing tools? These were two of the questions discussed at a workshop jointly organised by the European Medicines Agency (EMA) and the Maltese Presidency of the European Union (EU) that brought together regulators from across the EU and Africa in Malta on 2 and 3 March 2017.

One of the tools discussed was the scientific assessment of medicines or vaccines for use outside the EU that EMA can conduct in line with European legislation (under the so-called ‘Article 58’ procedure). These assessments are carried out in cooperation with the World Health Organization (WHO) and aim to increase access by patients in low- and middle-income countries (LMICs) to high quality, safe and effective medicines. The overall goal of this procedure is to contribute to improving global health.

‘Effective medicine regulation plays a crucial role in every health system to ensure that all medicines are safe, effective and meet approved standards,’ said EMA Executive Director Guido Rasi. ‘I am confident that by increasing our two-way dialogue and the information on regulatory tools available we can strengthen international collaboration and benefit patients.’

In order to better understand the needs of regulators in LMICs throughout a medicine’s life span, scientific experts from EMA’s Committee for Medicinal Products for Human Use(CHMP) and African regulators discussed their respective operating environments. Participants also discussed how to improve procedures to enable non-EU regulators to use EMA’s scientific outputs, such as public assessment reports for medicines. This is the first time that CHMP experts have met with non-EU regulators in such a forum.

Discussions at the meeting focused on:

• how to improve communication flows between EMA, WHO and countries that rely on Article 58 opinions for their national decisions, and on safety monitoring;
• improving the CHMP benefit-risk assessment in relation to the conditions of use of a medicine outside the EU, and its risk management plans;
• earlier and deeper involvement of experts and observers from target country regulators in Article 58 procedures;
• systematic follow-up from CHMP to target country authorities after each Article 58 opinion;
• increasing opportunities for training and capacity building.

The workshop was organised with the support of the Bill & Melinda Gates Foundation and WHO. It is in line with the World Health Assembly Resolution WHA67.20 which calls on WHO to raise awareness of the importance of effective regulatory systems within the health system context.

A report from the meeting will be published shortly.

Related content

• Opinions on medicines for use outside the European Union
• Article 58 applications: Regulatory and procedural guidance
• Partners & networks: World Health Organization