1-Regulatory Affairs Department

The department receive and review the requirements of new products registration and variant application. The department also, communicating and coordinating with pharmaceutical companies regards missing requirements in registry file and procedures of pharmaceutical products registration. Supervising the archiving of pharmaceutical products files and store samples in a proper storing conditions is another task. Finally, Following, developing and receiving inquires and suggestions related to the electronic systems at drug sector.

2-Facilities Licensing Department

The facilities licensing department issues licenses for the following facilities: Pharmaceutical products factories, Cosmetics products factories, Pharmaceutical, cosmetics and chemical substances warehouses, Pharmaceutical consulting centers, Pharmaceutical and cosmetics products analyzing laboratories, Bioavailability and bioequivalence centers, Scientific boards, and blood bank based on law and regulation for each type through coordination with executive department of the inspection and enforcement of regulation.

3-Product Licensing Department

     3A-Human Drugs Department

Human drugs department fellow up human product registration through product manager who review all the requirements as second reviewer before proceed to next step. The department also, Coordinating the human drugs licensing committee meetings and Organizing the gulf committee to drugs registration meeting files. Finally, the department issue CPP certificate.

     3B-Health and Herbal Products Section

The department monitor the process of register health and herbal products which might be as a pharmaceutical form, containing a medical claim or added to the products as a substance that has a treatment characteristics. The section also, issue CPP certificate for health and herbal product.

      3C-Veterinary Drug Section

Veterinary Drug section receive and review the veterinary products submitted files and disclose them to the registration committee. In addition,  the section Receives and monitor variant applications and refer them to the Product Evaluation and Standard Setting directorate then to Veterinary registration committee. The section also, Issuing the free sale certificate for the local companies.

      3D- Product Marketing and Advertising Section 

The section receive and review Product Marketing and Advertising requests and Transfer the request to the advertising committee for approval. The section also, issues the final approval for drug advertising and the approval for scientific lecture.  

4-Narcotics and control Drug Department

The department is responsible for monitoring the legal using of narcotics drug, psychotropic substances and precursor chemicals, and its availability to both governmental and private sectors through applying regulation and guidelines.

5-Pricing Department 

Pricing unit study the submitted product then suggested price for these products, according to the regulations and guidelines, to the  pricing committee. The department  present the companies complains about their products prices which suggested by the committee, and coordinating the meetings between the pharmaceutical companies,  Product Evaluation and Standard Setting directorate and pricing committee for economic point of view studies .

6 - Clinical Trail Department

Sections of the Department :
  • * Clinical Trials Evaluation
  • * Saudi National Clinical Trials Registry
  • * Monitoring and follow-up research centers and clinical trials (Clinical Trials Centers, CROs and GCP inspectors)