The SAMED Regulatory Committee has noted serval changes in the African regulatory landscape which members should be aware of. Countries, where changes are noted, include:

  • Egypt: Guidelines (in Arabic) published by the Egyptian Drug Authority (EDA) regarding the rules and requirements for the establishment of a scientific office in Egypt. A circular was issued by EDA that details how to address the MDR related changes, as to what changes will require variation submission, what changes will not require variation submission and finally classification changes.
  • Ethiopia: Issued a Guideline for Application of Accessories and Spare-parts
  • Ghana: Registration costs were updated
  • Morocco: A new circular (in French) was issued by the La Direction du Médicament et de la Pharmacie (DMP) in Morocco on Sep 8, 2021, highlighting the new procedures implemented for the submission and follow up requests via online platform and specific email addresses.
  • Mozambique: Several registration requirements have been added
  • Nigeria: A Medical Device label must include “Provision for the National Agency for Food and Drug Administration and Control (NAFDAC) Registration Number”. Registration of a product or item with NAFDAC does not automatically confer an advertising permit. A separate application and subsequent approval by NAFDAC shall be required if the product is to be advertised.

These changes have been captured in the African Regulatory Database (indicated in red) which is available on the SAMED Regulatory library.