African drug regulatory agencies to establish single information database  – TrendyNewsReporters

African drug regulatory agencies to establish single information database 


Some African Drug and Food regulatory agencies are currently in Abuja brainstorming on how to have a single database of information on drug and food regulations on the African continent.

The event, which kick-started on Monday, was organised by the African Union Development Agency (AUDA-NEPAD) in collaboration with the Nigeria National Agency for Food and Drug Administration and Control.

The News Agency of Nigeria reports that the discussion which focuses on the regulations of COVID-19 vaccines and other health issues in Africa is targeted at ensuring Smart, Safety, and Surveillance (AU-3S) of all the regulated products.

Speaking to newsmen at the event, NAFDAC Director-General, Prof Moji Adeyeye, disclosed that AU-3S had become a mini umbrella the agency would be relying upon for information sharing in each country.

She said that from the NAFDAC perspective, it was not only monitoring the safety of food and drugs, but the agency was also monitoring the distribution of the products.

Adeyeye said that the agency had already started sharing information between each African country with anti-retroviral, anti-tuberculosis, and anti-malaria, adding that NAFDAC work was already set up in AU-3S.

“COVID-19 vaccine is a pilot, we are going to be monitoring other products, essential medicine, in particular, that is relevant of AU-3S in Nigeria.

“We are linking our activities in tackling substandard, falsified medicine to what AU-3S is doing, safety and quality efficacy. In Nigeria, we are putting together a mechanism to control the quality of medicines in particular.

She said NAFDAC was using traceability in Global Standard one (GS1) in driving technology and actually using it as part of safety monitoring in Nigeria.

She added that once the medicine got to the national cold store of the primary healthcare agency, the agency always did the commissioning and the scanning of all vaccines that entered Nigeria.

“Once we finished the scanning, the primary healthcare agency takes over and distributes to the national and sub-national, which includes states, and local government healthcare facilities.

“We do this successfully in Nigeria; we use the template that we got in our database, traceability information system to do our monitoring and regulations,” she said.

She said that the agency was working towards keeping the confidence of the agency in the consumers and ensuring that they got quality.

Dr. June Raine, Chief Executive Officer (CEO), United Kingdom (UK) Medicine and Healthcare Products Regulatory Agency (MHRA), stated that the initiative would bring about effective regulation and support for technical expertise.

According to her, safety in vaccines and protection is a global initiative, and that AU-3S will help with how resources are deployed in different countries.

She added that it would help in the scaling-up prototype of drug regulation in each country, and help in the healthcare sector.

Mrs. Delese Darko, CEO, Food and Drug Authority, Ghana, said that it would bring about strong capacity in each country’s existing programme.

She added that the synergy in information sharing on drug and food regulations would bring confidence when reporting to the government.

Dr. Boitumelo Semete-Makokotlela, CEO of South Africa Health Products and Regulatory Authority (SAHPRA), stated that the initiative would bring about an update on information sharing, and improvement to other therapeutics areas.

Dr. Dan Hartman, Director, Integrated Development Global Health, Bill and Melinda Gates Foundation, stated that the initiative would assist in moving to a world where seamless transfer of data and knowledge was possible.

Mr. Mahmuda Mamman, Permanent Secretary, Federal Ministry of Health, said that the initiative would assist policymakers in making a decision.

According to him, a good decision can make healthcare delivery across Africa and the world very easy.



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