SFDA Break Through Medicine Guidance Update

SFDA – هيئة الغذاء والدواء issued an amended guideline on “Regulatory Framework for Drug Approvals”, version 6.4, of June 2024 (“Drug Approval Guideline“). The updates focus on granting Saudi Food & Drug Authority (“SFDA“) more discretion in cancelling application requests and and adds a section regarding the process for designating a medicine as a breakthrough medicine.

GUIDELINE OVERVIEW

In general, the SFDA has developed this administrative document to provide assistance for stakeholders on how to submit applications for various types of drug products and the procedure to approve the applications. Besides the Market Authorization Application (“MAA“) of various types of drug products, it also describes variations applications and renewal of the MAA. Time-frames for processing applications through to marketing the product in Saudi Arabia are also included in this document.

This framework applicable to all types of drug product submitted for registration, variation or renewal.

New Marketing Authorization Application:

Amendments in this section focus on the parameters surrounding SFDA’s ability to cancel an application request, lowering the threshold and providing SFDA more discretion in cancelling an application.

SFDA has clarified that an MAA request may also be rejected “if the applicant provided unsatisfied requirements or did not include the required documents or justification for the absence of a document according to SFDA guidelines.” Previously it was stated that the application would be rejected for “Failure to provide acceptable clarifications after the third wave.”, but this has been removed. It remains that it may be cancelled in the case that there is no response from the applicant within 30 working days.

Previously, “The applicant will have a total of four (4) waves for Evaluation / inspection and Pricing” and “The registration request will be rejected in . . . Failure to provide acceptable clarifications after the 4th wave.”

Now, the updated version gives SFDA an lower threshold to cancel the application, stating “The applicant will have a maximum of four (4) waves for Assessment and pricing, and the SFDA has the right to take a decision at any time during the assessment step, regardless of the wave number.” Allowing the SFDA to cancel the registration request “If the applicant provided unsatisfied requirements or did not include the required documents or justification for the absence of a document according to SFDA guidelines.”

Breakthrough Medicine Designation:

This new section incorporates the updated (v1.1 of the April 2024) Breakthrough Medicine Program guidance document. The Breakthrough Medicine Program is intended to expedite the development and review of new drugs that can treat serious or life-threatening conditions where there is a lack of effective treatment options. The goal is to ensure that promising drugs are made available as soon as possible, provided that their benefits outweigh their risks. (See my subsequent post on the Breakthrough Medicine Program guideline).

Variation of Marketing Authorization:

Similar to the MAA application section, SFDA has expanded its authority to cancel a variation application, granting itself more discretion.

Previously, an application would be cancelled for “Failure to provide acceptable clarifications after the second wave”. Now, “If the applicant chose the wrong variation type according to the Guidelines for Variation Requirements, provided unsatisfied requirements, or did not include the required documents or justification for the absence of a document according to relevant SFDA guidelines.” It remains that SFDA may cancel the variation request if no response is received from the applicant within 30 working days.

Similarly, it was added that while the applicant will have a maximum of three (3) waves for Assessment, and pricing, “the SFDA has the right to take a decision at any time during the assessment step, regardless of the wave number”, and cancel the application.

Finally, reference to the applicants right to appeal within 60 calendar days of the SFDA’s final decision, was removed, however, it is expected that the right to appeal a decision, submitting an Objection Request, is still available to applicants under the latest version of the SFDA’s appeal policy on the eSDR website.

Objection Requests

As per the eSDR website, the types of objections that can be made are:

• If the product registration request is accepted, the system allows the company representative to raise objection to the price and the expiry duration;
• If the request for “Variation” is accepted, the system allows the representative of the company to raise objection to the price only;
• If the product registration request is rejected, the system allows the company representative to raise objection to the rejection decisions;
• If a price adjustment request is rejected, the system allows the company representative to raise objection to the rejection decisions;
• If a request for modification of non-price data is rejected, the representative of the company is not allowed to request an objection, and requests variation again;
• If a request for a price adjustment and other data is rejected in the same order, the representative of the company can only raise objection to the decision of rejecting the price and submit a request for an adjustment to the rest of the data;
• If a request for cancellation is rejected, the representative of the company can submit objection to the rejection decision;
• If a renewal request is rejected, the representative of the company can raise objection to the rejection decision; and
• If the renewal request is accepted, the company representative is not allowed to object any rejected request prior to the renewal date.

Renewal of Marketing Authorization

As with the other sections, the SFDA removed “failure to provide acceptable clarifications after the first wave” and instead, SFDA may now cancel a renewal request for “failure to provide acceptable clarifications.”

It remains that the applicant has the right to appeal a pricing decision within 60 calendar days of the SFDA’s final decision (for more information refer to the SFDA Policy of Appeal to Drug Sector Decisions).