Saudi Arabia: SFDA Break Through Medicine Program

In October 2023, the Saudi Food and Drug Authority (‘SFDA‘) issued a guidance document on its new breakthrough medicines program (‘BMP’). The BMP aims to facilitate and accelerate development and review of new drugs that address unmet medical need in the treatment of serious or life-threatening conditions.

Under the breakthrough medicine program, the designation request may be submitted by the end of phase 2 trials, or at any time after. All four criteria must be fulfilled in order to gain a breakthrough medicine designation:

1. Target serious debilitating or life-threatening conditions with unmet medical need;
2. The medicinal product is likely to offer major advantage over methods currently used;
3. The potential adverse effects of the medicinal product are considered to be outweighed by the benefits, allowing for the reasonable expectation of a positive benefit/risk balance; and
4. The product is not registered at any regulatory authority at the time of submission of the designation request.

As part of the application for designation as a BMP and completion of the Breakthrough Medicine Designation Form, the applicant should submit preliminary evidence, based on non-clinical and clinical data, that the advantage claimed for the product may be of significant relevance to the patient and will address their unmet need. A well-argued evaluation of the likelihood of achievement of the product’s claim should be provided, based on the totality of information available at the time of designation.

Following granting of the BMP designation, an applicant must submit the medicine application file within 30 working days after granting the designation. The application shall be submitted through Saudi Drug Registration (‘SDR‘) System and according to the SFDA’s “Guidance for Submission”. The applicant may request an exemption for one or more of the registration requirements, if unavailable (e.g. CPP, leaflet and artwork). The scientific assessment takes 60 working days. When the SFDA has sufficient information about the product, it will make a decision on whether or not a medicine should be granted a marketing authorisation.

Importantly, the company can start the medication access negotiation process with all involved healthcare entities in parallel with application review.

How can we help?

Al Tamimi & Company’s Healthcare & Life Sciences practice in Saudi Arabia spans all three of our KSA offices (Riyadh, Jeddah, & Al Khobar) and is well placed to advise on regulatory matters impacting the life sciences industry, such as the SFDA Break Through Medicine Program.