Saudi Arabia introduces new draft rules for veterinary vaccine registration to boost animal and food safety

Saudi Arabia’s Food and Drug Authority has published draft regulations requiring comprehensive non-clinical evidence for veterinary vaccine registration, aiming to enhance safety standards and environmental safeguards.

Saudi Arabia’s Food and Drug Authority has issued draft rules setting out the non-clinical evidence required before veterinary vaccines can be registered, in a move intended to standardise laboratory assessment and strengthen safeguards for animals, consumers and the environment.

According to the authority, the proposed framework applies only to veterinary vaccine applications and does not cover veterinary pharmaceuticals or herbal products. It is open for comment, with enforcement to follow at a later date.

The draft says companies must submit full study reports rather than summaries, covering single-dose, repeat-dose and overdose testing, as well as reproductive effects. It also distinguishes between live and inactivated vaccines, and between food-producing and non-food-producing animals. For products used in the food chain, the authority would require residue studies to protect human consumers, although vaccines without active pharmaceutical ingredients may be exempt after scientific review.

Manufacturers would also need to demonstrate immunogenicity, along with the onset and duration of protection. The proposal further requires environmental risk assessment, including any potential spread beyond the target species.

The authority says all studies must have animal ethics approval, with local oversight committees registered with the National Bioethics Committee. Laboratory work would need to comply with good laboratory practice, while field studies would have to follow good clinical practice and ICH guidance. The SFDA, established in 2003, says its remit includes veterinary medicines and other health-related products.

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