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USP trains local pharmaceutical industries on common technical document dossier format

By Stanley Akpunonu   |   02 March 2017   |   3:36 am

Participants at training on Common Technical Document (CTD) dossier format compilation for local drug manufacturers by the Promoting the Quality of Medicine (PQM), a United States Agency for International Development (USAID)- funded programme of the United States Pharmacopeia (USP) held in Ikeja, Lagos

As part of efforts to build the technical capacity of the different local pharmaceutical manufacturers and ensure uniformity of product data irrespective of the country of manufacture, the Promoting the Quality of Medicine (PQM) programme conducted training on Common Technical Document (CTD) dossier format compilation for local drug industries.

PQM is a United States Agency for International Development (USAID)- funded programme implemented by the United States Pharmacopeia (USP).

Chief of Party PQM in Nigeria, Dr. Chimezie Anyakora, said the training which was held in Ikeja, Lagos was aimed at building the technical capacity of the different local pharmaceutical manufacturers on the CTD based dossier compilation process to ensure uniformity of product data irrespective of the country of manufacture, thus increase access to a steady supply of essential medicines of assured quality, safety, and efficacy across Africa and the world.


Anyakora said PQM has been providing technical assistance to Nigeria to strengthen the regulatory capacity and to increase the supply of locally manufactured quality-assured priority medicines to protect public health.

He said PQM has been supporting local manufacturers, National Agency for Food Drug Administration and Control (NAFDAC), Federal Ministry of Health and other stakeholders to build their capacity. “PQM technically supports some local manufacturers to increase the supply of quality-assured maternal and child health priority medicines and antimalarial medicines,” Anyakora said.

The pharmaceutical Chemist said the dossier is the documentation submitted to a National Regulatory Authority as part of the requirement to get marketing authorization in a country.

Anyakora explained: “Regulatory documentation and requirement within the industry is undergoing profound changes, thus international consistency of all relevant information of medicinal product is extremely important. NAFDAC is transitioning to a CTD format of dossier compilation for companies seeking marketing authorization in Nigeria.

“To bridge the knowledge gap PQM conducted this training, which was well received by the manufacturers.”

One of the participants Toyosi Meshioye from Fidson Healthcare described the training as an eye opener. Also Mr. Declan Mgboji of Emzor Pharmaceutical Limited described it as very impactful. Many other participants from different companies across the country showed great appreciation for the opportunity.




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