Incentive list: Unregistered or unavailable pharmaceutical products that currently on need

Introduction:

Toward achieving the Saudi vision for 2030, one of the SFDA strategic goals is to increase the availability of trusted pharmaceutical products to meet the most essential public need and ensure drug security for the country. The incentives list include unregistered or unavailable pharmaceutical products that currently on need to encourage pharmaceutical companies to register these medicines.

Incentive list :

Incentive list link

The incentives:

Assessing the applicability of the following incentives:

1. Priority in registration
2. Flexibility in pricing
3. Support and exemption from some technical requirements
4. Reducing registration and inspection fees

Incentives Request Submission:

Fill the Incentives application, and send it to:Drug.Incentives@sfda.gov.sa

Registration guidelines:

1. The Registration Rules of Pharmaceutical, Herbal and Health Product Manufacturers and their Products Guideline
2. The Regulatory Framework for Drug Approvals
3. Guidance for submission
4. The Data Requirements for Human Drugs Submission Content of the Dossier