Saudi Food and Drug Authority’s Requirements on Child-Resistant Packaging for Medications Posing Substantial Toxicity Risk.
Introduction:
The Saudi Food and Drug Authority (SFDA) stands as an unwavering guardian of patient safety in the Kingdom of Saudi Arabia (KSA). Renowned for its commitment to stringent and meticulous regulatory practices within the GCC region, the SFDA has emerged as a vital pillar in ensuring the well-being of the nation’s citizens. With a steadfast dedication to uploading the highest standards of pharmaceuticals, the SFDA’s rigorous scrutiny and protocols serve as a testament to its commitment to safeguard the health and welfare of KSA’s population.
Keeping in line with their commitment, the SFDA recently issued a guidance document to establish requirements for the medicinal reclosable packaging that may cause risk of toxicity to children (if accidentally ingested). It also provides a list of medicines which qualify for child-resistant packaging [1].
Child-resistant packaging (CRP) plays a pivotal role in safeguarding young children from accidental poisoning caused by the ingestion of pharmaceutical products. While it’s important to note that “child-resistant” does not equate to “child-proof,” the SFDA recognizes the importance in slowing down children’s access to package contents.
Preventing Accidental Poisoning
The primary objective of this initiative is to address the alarming issue of accidental poisoning among children, particularly due to the ingestion of medicines. Indeed, a study conducted in 2019 demonstrated that accidental ingestion of medicines was among the leading causes of paediatric acute poisoning [2]. The SFDA emphasizes the importance of secure storage of all medications, ensuring they are out of reach of curious young hands. The central focus, however, remains on establishing stringent requirements for the packaging of medicines with significant toxicity risks if accidentally ingested.
Defining Child-Resistant Packaging
Child-resistant packaging is a careful balance between creating a barrier that young children find challenging to open while remaining accessible to adults. An essential component of this packaging solution is the re-closable container, designed with a secure closure cap that maintains its effectiveness even after multiple openings and closings. This cap is pivotal in sealing the container against external factors, ensuring the integrity of the product within.
Key Requirements for Child-Resistant Packaging
The document outlines several pivotal requirements that pharmaceutical manufacturers must adhere to when implementing child-resistant packaging:
- Longevity and Functionality: The closure cap must retain its functional properties until the medicine’s expiry date, ensuring prolonged child-resistant capabilities.
- Durability: The packaging must maintain its child-resistant properties throughout its anticipated lifespan of use.
- Material Composition: The closure cap should be constructed solely from plastic, ensuring consistency in its effectiveness.
- Clear Instructions: Comprehensive instructions for opening and reclosing the package must be provided, facilitating proper usage by adults.
- Preservation of Child-Resistant Feature: The packaging’s child-resistant feature must not be compromised by the contents it holds, maintaining its efficacy.
- Application Process: Manufacturers must convey information regarding child-resistant packaging through the appropriate submission channels.
Implementation and Compliance
For new drug submissions, manufacturers must provide comprehensive details regarding the child-resistant properties of their packaging, backed by specific data requirements. In the case of registered products or modifications to packaging composition, variations must include exhaustive information about the packaging system, aligning with relevant guidelines.
Conclusion
The emphasis on child-resistant packaging for pharmaceutical products demonstrates the Saudi Food and Drug Authority’s commitment to enhancing child safety and preventing accidental ingestion. By adhering to these guidelines, manufacturers can contribute to a safer environment for children while ensuring the accessibility and proper usage of medications by adults. This initiative signifies a crucial step toward reducing the occurrence of accidental poisoning and its devastating consequences.
As a leading regulatory consulting organization, DDReg has extensive global coverage and experience of the Saudi market for product filings. The regulatory affairs teams is well-versed with the stringent guidelines of the SFDA, and has supported its customers for product registrations, post-approval lifecycle management, and pharmacovigilance in Saudi Arabia.
References and Further Reading
[1] SFDA. Child Resistant Packaging Requirements. Saudi Food and Drug Administration. 2023.
[2] Alruwaili, Nahar Dakeel, Bachar Halimeh, Mohammed Al-Omar, Badria Alhatali, Ismail Ibrahim Sabie, and Mohammed Alsaqoub. “An epidemiological snapshot of toxicological exposure in children 12 years of age and younger in Riyadh.” Annals of Saudi medicine 39, no. 4 (2019): 229-235.