مبادرة التحفيز: قائمة المستحضرات الصيدلانية غير المسجلة أو غير المتوفرة المطلوب تسجيلها في الهيئة

Introduction:

In an effort by SFDA to participate in achieving the Kingdom of Saudi Arabia's Vision 2030, and based on our strategic objectives to enhance product availability, and given the presence of unregistered or unavailable pharmaceutical products despite the local market's need for them, the incentive project was launched to encourage pharmaceutical companies to register unregistered medicines and medicines for which alternatives are required to be registered.

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