Around The Globe

Africa on the Move: Regional Initiatives Gain Momentum in 2018

David Makunga
Global Forum
Africa Regional Editor


he new year is only three months old, yet several African regions are progressing rapidly and making plans to advance a number of initiatives in regulatory harmonization and standards setting.

Prominent among them are various regional procedures for joint assessment of sponsor applications – an effort to streamline the assessments while leveraging and sharing scarce resources: the East African Community (EAC) Medicines Regulatory Harmonization (MRH) Initiative, the Economic Community of West African States (ECOWAS), the Southern Africa Development Community (SADC), and the Africa Vaccine Regulatory Forum (AVAREF).

East African Community (EAC) Medicines Regulatory Harmonization (MRH) Initiative

  • The Government of Rwanda’s Act to establish the Rwanda Food and Drugs Authority was approved by the head of state and announced at the end of February 2018.
  • Joint dossier evaluation sessions will be held the third weeks of March and June 2018.
  • The EAC MRH Initiative Steering Committee adopted a plan to revamp the joint assessment process addressing the pain-points identified by stakeholders, including industry. The new plan focuses on using dedicated resources within the regulatory agencies to coordinate the receipt and review of industry applications. The new plan will establish a single point of contact for industry by the end of June 2018 for submission and follow-up of applications.

Economic Community of West African States (ECOWAS)

  • Regional Expert Working Groups (EWGs) were established and launched during the last week of February 2018 to provide technical support for the implementation of the MRH initiative in West Africa. EWGs consist of experts from all 15 National Medicines Regulatory Authorities and will be responsible for drafting guidelines and harmonized technical procedures for the various components of the program.
  • ECOWAS will hold the first joint dossier assessment session the last week of June and the second week of October 2018.
  • A WHO regional workshop on Substandard and Falsified (SF) Medical Products will take place in Lagos, Nigeria, on April 16-20, 2018.

Southern Africa Development Community (SADC)

  • In addition to the evaluation session held in February this year, the SADC will hold another three joint dossier evaluation sessions in 2018: the second week of June, the third week of August, and the last week of November.

Africa Vaccine Regulatory Forum (AVAREF)

  • AVAREF is organizing two workshops, one each in ECOWAS and EAC, to support the member state regulators and national ethics committees to adopt AVAREF formats, guidelines and standards for clinical trial applications, and regulatory oversight. This is a step towards ensuring that African countries use the same requirements and standards for clinical trials.
  • In 2018, AVAREF will develop a procedure to allow clinical trial applicants request and hold pre-submission meetings with regulators and ethicists under the AVAREF platform. These meetings will provide information on the AVAREF process and advice on clinical trial designs and ethical considerations.