Regional strategy on regulation of medical products adopted

Brazzaville, 22 August 2016 – Every day, fake medicines and medical products are sold at street corners, in open air markets or on unregulated websites in several countries in the African Region. These poor quality, unsafe medicines and products promote drug resistance and lead to loss of confidence in health professionals, pharmaceutical manufacturers and distributors and in health systems.

In an effort to protect people’s health, the WHO Regional Director for Africa, Dr Matshidiso Moeti, has proposed a strategy aimed at strengthening National Medicine Regulatory Authorities (NMRAs) in order to ensure that only safe, good quality and effective medical products are available in countries. The strategy was presented at the annual meeting of Health Ministers from the WHO African Region (the 66th session of the WHO Regional Committee for Africa) which is taking place in Addis Ababa from 19-23 August 2016.

“Functional regulatory systems ensure that medical products consistently meet international standards and are monitored from clinical evaluation to licensure and use. They play a critical role in protecting people’s health and strengthening health systems to contribute to Universal health Coverage,” said Dr Matshidiso Moeti, WHO Regional Director for Africa

WHO has been supporting countries in the Region to strengthen their regulatory systems through several collaborative initiatives including the African Vaccine Regulatory Forum, the African Medicines Regulatory Harmonization initiative, harmonization projects in regional economic communities and the African Medicines Agency. 

Despite these, countries still face challenges in the governance of their regulatory systems, as well as in the human, financial and technical resource capacity required to function effectively. In addition, access to quality medical products is delayed by the time-consuming examinations and approvals of clinical trials and product registration.

In a strategy aimed at ensuring that NMRAs are strengthened to effectively fulfil their regulatory functions, Dr Moeti highlights a range of actions to be taken by countries. By 2018, countries are expected to ensure that a regular surveillance of all medical products circulating on the market is carried out. During the same timeframe, it is recommended that countries have access to certified quality control laboratories, and embark on joint reviews of applications for clinical trials. The Regional Director urged countries to establish governing bodies and quality management systems for NMRAs by 2025. She also urged that by the same period, application for clinical trials or marketing authorization of medical products takes a maximum of six months.

It is expected that countries will provide adequate human, financial and technical resources for the NMRAs to be functional and harmonize their regulatory practices with international recognized standards and initiatives.

Every two years, there will be an assessment of how countries are implementing the strategy based on a set of agreed indicators.

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For more information, please contact:

Dr Delanyo Dovlo, Director of Health Systems Strengthening, WHO AFRO; Email: dovlod [at] who.int 

Fabienne Aboua, Communications Officer, WHO AFRO; Email: abouaf [at] who.int 

Collins Boakye-Agyemang, Regional Communications Adviser, WHO AFRO; Tel: + 242 06 520 6565; Email:boakyeagyemangc [at] who.int

Loza Mesfin Tesfaye, Communications Officer, WHO AFRO; Tel: +251 911 144 194; Email: tesfayel [at] who.int 

Pieter Desloovere, Communications Consultant, WHO AFRO; Email: deslooverep [at] who.int

AFR/RC66/13 Regional strategy on regulation of medical products in the African Region, 2016–2025