Jun 22, 2022 | Basic page

Scope of Work

RCOREs have been categorised according to their areas of expertise and strength in training and / or service delivery in at least one of the following regulatory functions:

  1. Assessing the safety, efficacy and quality of medicines, and issuing marketing authorisation;

  2. Clinical trials oversight;

  3. Licensing of the manufacture, import, export, distribution, promotion and advertising of medicines;

  4. Pharmacovigilance and Pharmacoepidemiology;

  5. Inspection and surveillance of manufacturers, importers, wholesalers and dispensers of medicines;

  6. Providing independent information on medicines to professionals and the public; and

  7. Quality Assurance and Quality Control of medicines and medical devices.

In addition, institutions providing training in the following areas could be considered for designation as RCOREs: medicines laws and policies, Regulatory Systems, NMRA Quality Management Systems (QMS) and Regulatory Information Management Systems (IMS), Good Regulatory Practices (GRPs), Regulatory Performance Monitoring, Pharmacoeconomics and Health Technology Assessment (HTA) and medicines pricing regulation.