SAUDI ARABIA Law and Practice Contributed by: Dr Saud Alromi, Mostafa Ihab, Mohamed Ramadan and Saleh Albadry, Mohammed Al Dhabaan & Partners Eversheds Sutherland
4.4 Orphan Medicines Extensions Extensions for Orphan Medicines in Saudi Arabia Availability of extensions Extensions are available for orphan medicines in Saudi Arabia. The SFDA provides a framework for orphan drug designation and offers incen - tives, including potential extensions, to encour - age the development of treatments for rare dis - eases. Applicable laws and main provisions The Saudi Arabian Patent Law and its imple - menting regulations provide the basis for pat - ent term extensions, including those for orphan medicines. The extensions aim to compensate for the time taken to obtain regulatory approval. The SFDA Guidance for Orphan Drug Desig - nation outlines the criteria and procedures for obtaining orphan drug designation. It includes provisions for incentives to support the develop - ment and availability of orphan drugs. The SFDA offers various incentives for orphan drugs, including regulatory support, fee reduc - tions, and potential extensions of market exclu - sivity. 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 medi - cine must be intended for the diagnosis, preven - tion, 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
medicines and grants approval, which is a pre - requisite 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 pae - diatric 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 regula - tion and approval of these medicines. Applicable Laws and Main Provisions The SFDA is the primary regulatory body respon - sible for the approval of pharmaceuticals, includ - ing paediatric medicines. The SFDA’s regulations ensure that medicines are safe, effective, and of high quality. Regulatory Framework The SFDA has specific guidelines for the approv - al of paediatric medicines. These guidelines require that the medicines meet stringent safety and efficacy standards tailored to paediatric use. Clinical Trials and Data Requirements For a medicine to receive an MA for paediat - ric use, the applicant must provide clinical trial data demonstrating the safety and efficacy of the medicine in children. This data must comply with the SFDA’s requirements for clinical trials. Labelling and Packaging The SFDA also mandates specific labelling and packaging requirements for paediatric medi - cines to ensure proper usage and dosage.
262 CHAMBERS.COM
Powered by FlippingBook