The National Agency for Food and Drug Administration and Control (NAFDAC) has approved the production of four United Nations life saving commodities for women and children. The commodities include: chlorhexidine gel used in neonatal umbilical cord care, amoxicillin dispersible tablet used in Pneumonia, Zinc Sulphate for diarrhoea and misoprostol.
Announcing this at a two-day Common Technical Document, CTD, workshop in Lagos, the Director General of NAFDAC, Dr. Paul Orhii said Nigerians now have improved access to locally produced safe, efficacious and affordable medicines.
Orhii explained that some of the drugs before now were not manufactured in the whole of Africa.
Giving further insight into the life saving commodities, he explained that the agency decided to give its technical assistance towards the production of these drugs to make Nigeria self-sufficient in the manufacture and supply of quality, safe and efficacious medicines at affordable prices.
Continuing he added: “We have actively encouraged the local pharmaceutical industry to work towards attaining WHO prequalification which will facilitate access to medicines that meet unified standards of quality, safety and efficacy for HIV/AIDS, malaria and tuberculosis.”
Represented by the Director of Registration and Regulatory Affairs, NAFDAC, Dr. Monica Hemben Eimunjeze, he explained that the CTD workshop was one of the strategies adopted to ensure access to quality regulated medicines in the sub region.
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| L-R: Executive Secretary, Pharmaceutical Manufacturers Group of Manufacturers Association of Nigeria, Mr. Olakunle Okelola; Director, Registration and Regulatory Affairs, National Agency for Food and Drug Administration and Control, NAFDAC, Dr. Monica Eimunjeze and the Head, Drug Evaluation and Registration Department, Food and Drug Administration, Ghana, Dr. Mercy Acquaye, during NAFDAC’s Common Technical Document Workshop in Lagos ...recently |
According to him, the agency has fostered collaboration with relevant international organizations to support its drive to ensure processes are in line with best global practice.
Orhii said also said that the collaboration include the engagements with the World Health Organization (WHO) through the agency’s participation in the Collaborative Procedure for Registration of WHO Prequalified Medicines as well as Expedited Procedure for
Registration of the world health body prequalified vaccines.
“We now have World-class regulatory staff as a result of NAFDAC-WHO and NAFDAC-Global Fund joint activities and trainings; unprecedented secondment of NAFDAC Staff to the WHO in Geneva in 2015. The agency has joined the WHO Prequalification team as consultant assessors since January 2015,” he said
The NAFDAC boss also said that the agency has keyed into the United Nations Commission Life Saving Commodities for Women and Children (UNCoLSC) programme which seeks to improve access to the 13 life-saving commodities and has worked with several partners such as the Clinton Health Access Initiative (CHAI) to build systems and pathways to facilitate access to these products.
“In order to increase efficiency, application pathways have been streamlined,” Orhii said, adding; “We are fostering greater collaboration with other government agencies, civil society and professional organizations.”
He further said that the agency is establishing and building closer ties with other nations and international organizations to ensure importation of good, quality, safe and efficacious medicines and other regulated products into Nigeria which has resulted in remarkable landmark achievements.
The NAFDAC DG said: “We have also partnered with stakeholders to build capacity of professionals, serving as Resource in several areas such as a biopharmaceuticals and biosmilars, cosmetic regulation and product development.
“In 2013, the Mycotoxin and Pesticide Residue Laboratory obtained ISO 17025 laboratory accreditation by the American Association for Laboratory Accreditation (A2LA).
In October 2014, an extension to the scope of this accreditation was obtained with the Food Chemistry Laboratory also becoming accredited.
“In December 2014, the Central Drug Control Laboratory, Yaba obtained ISO 17025 accreditation from the Ansi-ASQ National Accreditation Board (ANAB),” Orhii added.
This story was published in Newswatch Times on February 11, 2016.
