Snapshot

The Breakthrough Medicine Program pathway has been developed by the of Saudi Arabia.

This pathway can be used where new drugs that address unmet medical need in the treatment of serious or life-threatening conditions..

This pathway facilitates activities during development.

It is an abridged review (a reliance pathway).

The scientific committee will review the application (the review normally takes 30 working days of the receipt of the applicant's request). The focus of the review is restricted to (1) the potential of the medicinal product to fulfil the eligibility criteria, and (2) the format of the data to be submitted, data availability, and readiness of the marketing authorisation application. Following the review, the scientific committee will decide on whether to grant a designation or not and the applicant will receive an email on the committee’s decision. Note: In case of rejected designation request, the applicant can utilise the SFDA’s scientific advice service or may consider other registration pathway. Breakthrough medicine designation may be withdrawn if emerging data were to show that the criteria are no longer met. Based on the completeness of the data, the applicant will be directed to one of the following: Case 1: Completed data (no need for further data collection): • Applicant must submit the medicine application file within 30 working days after granting the designation. • Application shall be submitted through Saudi Drug Registration (SDR) System and according to the “Guidance for Submission”. • Applicant may request an exemption for one or more of the registration requirements, if unavailable (e.g. CPP, leaflet and artwork) • Assessment of breakthrough medicine application: 1. The scientific assessment takes 60 working days; SFDA may send a set of inquiries to the applicant. 2. In case of inquiries, the applicant shall respond to SFDA’s inquires within 60 working days (this may be extended in exceptional circumstances). 3. 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. Case 2: Incomplete data (required to provide more data): • Applicant that is granted breakthrough medicine designation will be required to provide more data when the currently available data related to drug development is insufficient to make a decision and may require further clinical trials and collecting more data. • Scientific committee will conduct an assessment on the submitted data and provide scientific advice to help the applicant design and conduct a drug development program as efficiently as possible. • If advised to conduct a clinical trial, the applicant has to contact the healthcare entities to conduct the trials in accordance with the "Regulation and Requirements for Conducting Clinical Trials on Drug". • As the sponsor completes the required data, a marketing authorisation application can be submitted through Saudi Drug Registration (SDR) System according to the “Guidance for Submission”