The Product Evaluation and Standard Setting Executive Directorate is responsible for the evaluation of the quality of pharmaceutical products which are submitted to be registered (including Human and Veterinary drugs, Biological products, Herbal and Health products), as well as the safety and efficacy evaluation of the generic pharmaceutical products.

In addition, the Directorate is responsible for setting up the standards and guidelines for the registration of pharmaceutical products, manufacturers and establishments in accordance with the international standards.

Responsibilities:

• Evaluating the various products submitted for registration (Human and Veterinary drugs, Biological products, Herbal and Health products).
• Setting up the standards and guidelines for the registration of pharmaceutical products, manufacturers and establishments. This can be done in coordination with the Directorate of Licensing.
• Supervision of consultation services provided to the companies.
• Coordination with other directorates about the issues concerning product registration.
• Building an effective relationship with international regulatory authorities and scientific associations whether local or international.
• Coordination with the scientific committees in case a scientific opinion was requested.

Divisions:

• Product Evaluation Administration:
  • Generic Drugs.
  • Biologicals.
  • Veterinary Drugs.
  • Active Pharmaceutical Ingredients (API).
  • Herbal & Health Products.
  • Biostatistics.
• Products Variation Evaluation Administration.
• Product, Manufacturer and Establishment Guidelines & Standard Setting Administration:
  • Product Standards.