Combination products are the physical combination of two or more regulated components, including drugs, medical devices, biologics, foods, and cosmetics, into a single therapeutic or functional product. In Saudi Arabia, such combined components may require one or more marketing approvals from the Saudi Food and Drug Authority (SFDA). Therefore, understanding how the authority would consider your product is crucial to determining the appropriate product registration pathway.

This article elaborates on the SFDA’s current guidance and outlines the process for determining the pathway.

What are Combination Products?

A combination product contains two or more regulated components physically or functionally combined for a single intended use. The SFDA defines the following major types:

Integrated Combination Products: Components are combined into a single product, such as prefilled insulin pens or drug-eluting stents.
Non-Integrated Combination Products: Components are separate but packaged or labelled for combined use, such as a vaccine vial with a delivery device, or a drug that must be used with a specific light-emitting device.

How Are Combination Products Classified?

The Saudi Food and Drug Authority considers several factors to determine the appropriate regulatory pathway. These include:

Statutory Definitions: How each component is defined under the laws of Saudi regulations.
Proposed Indication/Claim: The intended use as stated by the manufacturer.
Primary Mode of Action (PMOA): Is the effect mainly pharmacological, immunological, metabolic, or something else?
- If the main action is pharmacological, it’s regulated as a drug.
- If not, and the action is mechanical, it’s a device (even if supported by drugs or biologics).
Equal degrees of action: Which sector is best equipped to address the unique safety and effectiveness questions?
Consideration of Expertise: assigned to the sector where the most relevant technical expertise lies.

Regulatory Process & Appeal

If the classification is unclear, companies can submit a classification request to the SFDA.
The Products Classification Department reviews and assigns the request to the leading sectors.
Complex cases are escalated to the Joint Advisory Committee.
If the sponsor disagrees with the classification, they may file an appeal within sixty (60) days.

Timelines

The evaluation timelines are based on the leading sector. For example, suppose a drug and a medical device are combined, and the SFDA assigns the review to the drug sector. In that case, the drug application timeline is followed.