About us:

The Department is responsible for supervising the pre-marketing period of facilities, pharmaceutical product, that includes the issuance and renewal of licenses necessary to allow them to operate and marketing in the Kingdom of Saudi Arabia.


To be a pioneer in the field of medical license practices and provides services in distinctive speed and accuracy contribute to the development  of drug sector.

Message :

Ensuring the safety, and efficacy of the product licensed through applying of  fellowed technical specifications.


-preparing and updating of regulations, codes on licensing of pharmaceutical products, facilities.

- Receiving and reviewing  new product registration and update files.

- Licensing of pharmaceutical establishments (facilities).

- issuing registration certification for human, and veterinary medicines and herbal and health products.

- Develop regulation and requirements for advertising and promotion product to public and professional.

- Pricing of medicines according to the rules and regulations of pricing law.

- Develop regulation and requirements for approval to conduct clinical studies.

- Processing of applications for clinical studies and issuance of approval.

​-Follow-up and development of electronic systems for the drug sector.