• The Act authorized to established a Clinical Trials Regulatory Division (CTRD) at NMRA which is responsible for the Co-ordination and assisting the Authority to regulate and control all aspects pertaining to clinical trials by means of ;

• • Co-ordination of clinical trial applications submitted for authorization, screening such applications for completeness, evaluation and preliminary review;
  • Issuance of Letter of authorization and extension of clinical trial authorizations
  • monitoring of Serious Adverse Events and Suspected Unexpected Serious Adverse Reactions reported from approved trial sites;
  • monitoring of variations and deviations to approved trials;
  • co-ordination of the issuance of sample licences to import investigational and non-investigational products as samples for clinical trials;
  • carrying out Good Clinical Practices inspections at trial sites
  • co-ordination of matters pertaining to cancellation, suspension or revocation of suspension of clinical trial authorizations and sample licences to import investigational and non-investigational products; and
  • provision of administrative assistance to the Clinical Trials Evaluation Committee established under the NMRA Act.

Definition of a Clinical Trial:

Any research study that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes. Interventions may include but are not restricted to substances such as drugs, cells and other biological products, vaccines, surgical procedures, radiological procedures, or any other item claimed to have therapeutic benefit. The terms “clinical trial” and “clinical study” are synonymous

 Scope and Responsibilities of the NMRA in the approval of clinical trials

NMRA regulates clinical trials conduct only for;

• - Unregistered medicine, medical device or borderline product
• - Registered medicine, medical device or borderline product outside the conditions of registration