SAUDI ARABIA Law and Practice Contributed by: Saud Alromi, Mostafa Ihab, Mohamed Ramadan and Saleh Albadry, Mohammed AlDhabaan & Partners Eversheds Sutherland
Patent Law The Patent Law provides the basis for extending the term of a patent to compensate for the time taken to obtain regulatory approval, including for paediatric medicines. Implementing regulations The implementing regulations to the Patent Law out ‑ line the specific procedures and requirements for obtaining a patent term extension, including paedi ‑ atric extensions. Regulatory approval The extension is contingent upon obtaining regula ‑ tory approval from the SFDA. The SFDA evaluates the safety and efficacy of paediatric medicines and grants approval, which is a prerequisite for the extension. Additional exclusivity Paediatric extensions provide additional market exclusivity beyond the standard patent term. This is intended to incentivise pharmaceutical companies to invest in the development of paediatric formulations. 4.3 Paediatric-Use Marketing Authorisations In Saudi Arabia, MAs are available for medicines that are already authorised but are developed specifically for children, even if they do not have a patent or SPC. The SFDA oversees the regulation and approval of these medicines. Applicable Laws and Main Provisions The SFDA is the primary regulatory body responsible for the approval of pharmaceuticals, including paedi ‑ atric medicines. The SFDA’s regulations ensure that medicines are safe, effective and of high quality. Regulatory Framework The SFDA has specific guidelines for the approval of paediatric medicines. These guidelines require that the medicines meet stringent safety and efficacy
This data must comply with the SFDA’s requirements for clinical trials. Labelling and Packaging The SFDA also mandates specific labelling and pack ‑ aging requirements for paediatric medicines to ensure proper usage and dosage. 4.4 Orphan Medicines Extensions Extensions for Orphan Medicines in Saudi Arabia Availability of extensions Extensions are available for orphan medicines in Sau ‑ di Arabia. The SFDA provides a framework for orphan drug designation and offers incentives, including potential extensions, to encourage the development of treatments for rare diseases. Applicable laws and main provisions The Saudi Arabian Patent Law and its implementing regulations provide the basis for patent term exten ‑ sions, including those for orphan medicines. The extensions aim to compensate for the time taken to obtain regulatory approval. The SFDA Guidance for Orphan Drug Designation out ‑ lines the criteria and procedures for obtaining orphan drug designation. It includes provisions for incentives to support the development and availability of orphan drugs. The SFDA offers various incentives for orphan drugs, including regulatory support, fee reductions and potential extensions of market exclusivity. These measures are designed to make it more feasible for companies to invest in the development of treatments for rare diseases. Key provisions To qualify for orphan drug designation, a medicine must be intended for the diagnosis, prevention or treatment of a rare disease or condition. The disease must be life-threatening or seriously debilitating, and the prevalence must be low, or the development must not be financially viable without incentives. Companies must submit an application to the SFDA, providing detailed information about the drug, its intended use and evidence supporting its designation as an orphan drug. The SFDA reviews these appli ‑
standards tailored to paediatric use. Clinical Trials and Data Requirements
For a medicine to receive an MA for paediatric use, the applicant must provide clinical trial data demonstrat ‑ ing the safety and efficacy of the medicine in children.
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