المملكة: 3 Alternative names and a mandatory catalog to prevent medication errors
Required Saudi Food and Drug Authority Pharmaceutical companies with new regulatory requirements to evaluate the names and designs of packaging Pharmaceutical preparations, with the aim of reducing medical errors resulting from verbal and visual similarities and speeding up registration procedures in the Kingdom.
The Authority issued a recent regulatory draft requiring applicants for registration of human medicines or modification of their designs to submit a maximum of two alternative trade names in Arabic and English.
The authority explained that this procedure ensures that names are technically evaluated in the event that the basic name is rejected to speed up approval, with the requirement that reliance be limited to scientific names approved by World Health Organization.
New legislation
The new legislation required the uploading of a high-resolution electronic design catalog that includes flat images of the external packaging and internal labels, in addition to the appearance of the initial packaging on the shelves.
The Authority stressed the need for the catalog to be supported by the text search feature to facilitate searching for scientific and commercial names and pharmaceutical forms.
Enhancing safety
In a step to enhance safety, the Authority held the companies’ pharmacovigilance officer responsible for pre-evaluating the proposed names and packaging designs.
She stressed the need to attach an official pledge from the official proving that the files conform to the guidelines to ensure that there is no similarity with medicines registered locally or internationally.
The Authority obligated companies to submit three additional proposed names if the first and alternative options were rejected.
Instant update
The regulations indicate that electronic forms and product documents must be updated immediately when accepting any alternative trade name submitted by the company.
These measures, which the authority put forward for polling on June 25, 2026, come as part of its ongoing efforts to promote and protect public health.
The step aims to build an effective regulatory system that protects society from medication ambiguities that may threaten patient safety.
- For more: Follow Khaleejion 24 Arabic, Khaleejion 24 English, Khaleejion 24 Live, and for social media follow us on Facebook and Twitter
