In order to strengthen its regulatory capacity in clinical trial and broaden access of Nigerians to new drugs, National Agency for Food and Drug Administration and Control (NAFDAC) has inaugurated the Nigerian Clinical Trial Technical Working Group (CT-TWG).
Director General of NAFDAC, Dr. Paul Orhii who inaugurated members of the Technical working Group at a ceremony in Abuja said the objective is to build and advance the clinical trial sector of the Nigerian Economy.
Dr. Orhii said clinical trial is one of the core mandates of the Agency which covers a wide range of clinical investigations and includes new chemical entities or herbal formations for which safety or efficacy profile has not been determined, drugs for new indications, drugs for patient groups, and academic trials among others.
According to him, the Agency has keyed into international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve human subjects in order to sufficiently cover these diverse areas.
He said NAFDAC has formulated clinical trial guidelines and regulations with the assistance of World Health Organization (WHO) saying its implementation will ensure the generation of credible scientific data that will not only be accepted intentionally, but also lead to a transparent process that will attract international investments.
Members of the group are drawn from a pool of experts led by the chairman, Association of Good Clinical Practice in Nigeria (AGCPN), Prof. Ifeoma Okoye and Co.-chaired by former Chairman of Independent National Electoral Commission, Prof. Maurice Iwu and several others with a mandate to review all current and past efforts at transforming the Nigerian clinical Research sector and synchronize these efforts in to one among others areas.