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SFDA Guidance: Good Regulatory Practice & National Diagnostic Reference Levels

Earlier today (27-October-2022) the Saudi Food & Drug Authority (SFDA) released updated guidance on "Good Regulatory Practice".

A Good Regulatory Practice is a set of principles and practices that are used to develop, implement, and revise regulatory instruments - laws, regulations, and guidelines - for the purpose of achieving public health policy objectives.

The purpose of this guidance is to present the high-level principles and considerations in developing and implementing regulatory instruments that support regulatory activities. It serves as a benchmark, guiding the SFDA in implementing best practices in regulating medical products.

Also, the guidance assists in keeping the SFDA's regulatory systems current as the technologies and systems in which they are employed evolve.

By incorporating GRP principles into their work, SFDA employees strive to set appropriate requirements and formulate fair, transparent, consistent, impartial, proportional, and timely decisions.

To know more about the Principles involved in GRP guidance, click this LINK.

The SFDA also released updated guidance on National Diagnostic Reference Levels for the purpose of identifying and establishing the National Diagnostic Reference Levels (NDRLs) for various diagnostic ionizing radiation applications, as well as clarifying the SFDA's requirements for applying these references.


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