Kokani.me Kokani.me
Okaz/Saudi Gazette
RIYADH — Minister of Health and Chairman of the Board of Directors of the Saudi Food and Drug Authority (SFDA) Fahd Al-Jalajel inaugurated the Breakthrough Medicines Program at the authority’s headquarters in Riyadh on Sunday.
The Breakthrough Medicines Program aims to give patients with life threatening or seriously debilitating conditions access to promising new medicines that do not yet have a marketing authorization when there is an unmet medical need.
The launching ceremony was held in the presence of CEO of the Ministry of National Guard Health Affairs Dr. Bandar Al Knawy, Governor of the Saudi Standards, Metrology and Quality Organization Dr. Saad Al-Qasabi, CEO of SFDA Dr. Hisham Al-Jadhaie, and Deputy Minister of Health for Planning and Development Abdulaziz Al-Rumaih.
The program contributes to allowing rapid access of specific treatments to patients in Saudi Arabia, as well as to increase the treatment options available to the patient in the event of failure of standard medications. It also aims to reduce treatment expenses abroad by providing early access to innovative and modern medicines, and shortening the period required for the medicine to enter the Saudi market.
Breakthrough drugs are those that have completed the stages of clinical studies and demonstrated promising effectiveness and safety, and a clear therapeutic effect for incurable or rare diseases or that have a high prevalence in society. Among the necessary criteria for obtaining a promising drug classification is targeting serious, debilitating or life-threatening cases, and that the desired benefits of the drug outweigh potentially harmful side effects, and that the preparation has a significant advantage compared to what is currently used, in addition to not being registered with any regulatory authority at the time of submitting the application for registration.
It is noteworthy that SFDA began implementing this program experimentally, and the experiment achieved success in evaluating a number of products in parallel with the global regulatory authorities, and as a result it took qualitative decisions without relying on other regulatory authorities.
This program is an extension of the pioneering role of Saudi Arabia, and the support and follow-up that SFDA enjoys from the wise leadership, and its trust and empowerment for the people of the country. It also comes within the efforts made and pioneering initiatives that it has undertaken during the past years to accelerate the process of registering pharmaceutical preparations, medical devices and supplies, and the availability of medicines for patients in the Saudi market.
