March and April Issue
Maintaining International Standards at NAFDAC
The National Agency for Food and Drug Administration and Control (NAFDAC) has implemented a few changes in recent times which have the effect of putting the agency’s standards on par with some internationally maintained standards.
NAFDAC launched the 2016 guidelines for its regulatory activities. The guidelines were formulated in collaboration with the World Health Organization, Partnership for Transforming Health Systems 2 (Paths2) and UKaid.
The Acting Director General, Mrs. Yetunde Oni, stated that the guidelines were provided to assist stakeholders in their compliance with NAFDAC regulations. The guidelines also provide specifications on how NAFDAC requires the regulations to be implemented. The guidelines seek to ensure that safety practices, efficacy and good quality control measures are adopted by stakeholders to enable them compete on a global level.
The guidelines include: the Pharmacovigilance Practice Guidelines 2016, Good Distribution Guidelines 2016, Good Manufacturing Practice Guidelines for Pharmaceutical Products 2016, Good Clinical Practice Guidelines 2016 and Good Practices for Pharmaceutical Quality Control Laboratories Guidelines 2016.
Pursuant to these standards, the Agency issued a press release earlier this year where it was announced that NAFDAC had retained its status of accreditation of the Yaba Central Drug Laboratory in Lagos. The assessment conducted by the National Accreditation Board of the United States of America concluded that the operation of the laboratory conformed to the requirements of ISO/IEC 17025:2005. It was also stated in the press release that for the first time in Africa, two NAFDAC laboratories acquired accreditation by the American Association of Laboratory Association. These laboratories, the Mycotoxin laboratories and the Pesticide Residue Laboratories, also complied with the ISO 17025.
In addition, NAFDAC held a sensitization workshop on the 7th of March, 2016 aimed to create awareness on the need for NAFDAC officials to maintain high standards and avoid corrupt practices, and poor service delivery. The three-day workshop sensitized the NAFDAC personnel on the zero-tolerance policy against bribery, system studies, conflicts of interest, disclosure of confidential information and non-compliance with NAFDAC regulations.