المملكة: 30 days for express orders and 205 days for regular orders.. New controls for registering medicines

The General Food Authority proposed And medicine The draft regulatory guide for drug registration applications, specifying precise evaluation paths ranging from thirty to two hundred and five days, with a complete transition to electronic systems, with the aim of accelerating the provision of treatments in the Saudi market.

And obligated toTo the Saudi Food and Drug AuthorityPharmaceutical companies submit their files via the unified electronic system, announcing the final cessation of receiving CDs for registering human, veterinary and herbal preparations.

The new regulatory guideline specifies two hundred and five working days as a maximum for the regular path for evaluating innovative and biological medicines, while the period is reduced to one hundred and sixty days in the priority review path.

The Authority has allocated fast paths not exceeding thirty days for applications. Verification, and sixty days for shortened applications, to speed up regulatory review and drug approval.

All applications are subject to two stages of technical and practical verification, where companies are given thirty days to complete the deficiencies, after which the application is automatically rejected in the event of non-response.

The authority explained that the scientific evaluation cycle includes a review of quality, safety and pricing, with companies given sixty days to respond to the evaluators’ inquiries, divided into a maximum of four waves. Maximum.

The regulations have created exceptional paths that include continuous evaluation of promising medicines, registration of orphan medicines designated for rare diseases, and a path for innovative medicines to treat life-threatening conditions.

Applications that pass scientific evaluation are referred to the Pricing Department to determine the cost according to the approved rules, before submitting them to the Registration Committee to issue the final decision of approval, rejection, or conditional acceptance for two years.

The regulations guarantee companies the right to appeal within sixty days of the issuance of the decision, while It required providing accurate and convincing justifications if the company wanted to withdraw its medicinal product from the local market.

The Food and Drug Authority applies the same mechanisms to license renewal applications that take place every five years, in addition to reviewing minor and fundamental amendments to previously registered medicines, with completion periods ranging between thirty and sixty days.