Strengthening the Regulatory Framework of the Pharmaceutical Industry Sector in Africa

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Extract from the article: The Togolese Standards Agency (ATN), a technical entity of the High Authority for Quality and Environment (HAUQE) in partnership with the African Organization for Standardization (ARSO), held the first meeting of the ARSO/CT 78 Technical Committee...

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The Togolese Standards Agency (ATN), a technical entity of the High Authority for Quality and Environment (HAUQE) in partnership with the African Organization for Standardization (ARSO), held the first meeting of the ARSO/CT 78 Technical Committee on Medical Devices and Equipment from March 18th to 21st, 2024, in Lomé. The meeting aims to strengthen the regulatory framework of the pharmaceutical industry sector in Africa.

This meeting brought together experts from 13 key African countries in the medical and standardization fields across the continent. The main objective was to harmonize African standards for medical devices and equipment, a crucial step towards enhancing the regulatory framework of the pharmaceutical industry in Africa. It also aims to understand the importance of adopting and implementing harmonized standards to improve and ensure the quality, safety, and reliability of products and services.

On this occasion, 150 harmonized African standards were adopted, thus facilitating the development of equivalent technical regulations among African countries to promote the trade of health products. These standards complement the 337 African regulatory standards and guidelines already approved by ARSO in the pharmaceutical industry, including health services, pharmaceutical and medical products, traditional medicine, and technical regulation guidelines.

In his speech, the representative of the Minister of Investment Promotion, Sikpa Yawo, emphasized the importance of this initiative for standard harmonization and pharmaceutical product compliance. "This harmonization of standards, particularly in the pharmaceutical sector, will facilitate the development of equivalent technical regulations among African countries to promote the trade of products in this sector in our various countries," he said.

The Secretary-General of ARSO, Dr. Hermogene Nsengimana, highlighted the organization's role in harmonizing continental standards and assessing compatibility, emphasizing the importance of the ARSO/CT 78 Technical Committee in promoting free trade and safeguarding the health of the African population.

For the Director-General of ATN, Essot’na Héyou Bodjona, "medical devices and equipment are important for the diagnosis and treatment of patients; whether it's needles, syringes, catheters, blood pressure monitors, stethoscopes, scanners, MRI machines, etc., their quality is crucial for diagnosing the patient's condition and subsequent treatment."

Standardization emerges as a major discipline for supporting all sectors in the pursuit of quality, especially in the field of health.

Raymond DZAKPATA