SOUTH AFRICA— The South African Health Products Regulatory Authority (SAHPRA), & the Egyptian Drug Authority (EDA), have signed a memorandum of understanding (MoU), to foster collaborative engagements in pharmaceutical, biologicals, and medical devices regulations.
The new MOU intends to develop a synergistic relationship where both regulators share knowledge and engage in areas of market authorization, pharmacovigilance, Good Manufacturing Practices (GMP), and clinical trials.
The agreement was signed at the Egyptian Embassy in Pretoria and intends to deepen relations between both countries in the field of the pharmaceutical industry.
The delegations of both authorities headed by EDA Chairman, Prof. Dr Tamer Essam, and SAHPRA CEO, Dr. Boitumelo Semete-Makokotlela launched a comprehensive dialogue to exchange visions on a wide range of topics of mutual concern.
Dr. Semete-Makokotlela explained, “This is the first MOU that we have signed with a national regulatory authority in Africa which shows our commitment and drive to seek collaboration and knowledge sharing with our African counterparts. Capacity-building on the continent is critical because it will ensure that we remain firmly rooted in regulatory processes”.
The Ambassador of Egypt, Ahmed El-Fadly, expressed his satisfaction with the signature of the MoU, indicating that it helps remove one main non-tariff barrier to facilitating trade between both countries in the pharmaceutical sector, consequently enhancing people-to-people relations.
“The onus is now on relevant business communities in both countries to make the best out of this important development,” Amb. El-Fadly added.
This came within the framework of the Egyptian Drug Authority’s keenness to cooperate with African countries in the field of medical preparations and supplies, exchange experiences and support cadres working in the field of medicine, and support the entry of Egyptian medical preparations into regional and global markets, the EDA added.
The delegations of both authorities launched a comprehensive dialogue to exchange visions on a wide range of topics of mutual concern. They also discussed practical approaches
EDA Chairman, Dr. Tamer Essam, stressed that the MOU would pave the way for setting a unified vision and coordinating effective dialogue between African countries.
Moreover, the MOU would also support exchanging experiences in the field of pharmaceutical industries in a way that accords with the directives of the Egyptian political leadership to support joint African work.
This comes only a few weeks after Egypt’s drug regulator become a member of the International Council for Harmonisation, and it can incorporate the United States Pharmacopeia and the National Formulary standards into the Egyptian Pharmacopoeia.
The ICH is distinguished by integrating regulatory authorities and the pharmaceutical industry into discussing the scientific and technical aspects of drug registration.
The Council was established in 1990 and works to achieve global coordination for the development of safe, effective, and high-quality medicines, and to evaluate them efficiently.
Egypt as the first African Regulatory Authority to join ICH as a Member, along with NAFDAC, Nigeria as a new ICH Observer.
SAHPRA will lean on such advantages to grow its capacity and reach on the African continent, beyond South Africa.
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