logo
Saudi FDA Leading a Journey of Continuous Excellence and Development

Saudi FDA Leading a Journey of Continuous Excellence and Development

Dear reader, according to recent reports and statistics from the Saudi Food and Drug Authority (SFDA), significant and remarkable developments have been achieved over the past few years across all regulated sectors. These developments have solidified the SFDA's standing as a leading regulatory body, not only in the region but also globally. This continuous advancement is part of broader efforts to improve and regulate pharmaceuticals, medical devices, and food products, sectors that are critically important to public health.
SFDA is notably one of only three national regulatory bodies worldwide, alongside those of Singapore and South Korea, to have attained maturity level four (ML4) in the regulation of medicines and vaccines, according to the World Health Organization (WHO). Achieving this highest level of regulatory competency underscores the exceptional capabilities and efficiency of the SFDA. Furthermore, in 2023, the SFDA became the first Arab member of the Pharmaceutical Inspection Co-operation Scheme (PIC/S), an achievement that highlightsinternational trust in Saudi Arabia's pharmaceutical oversight capabilities.
Additionally, the SFDA collaborates closely with prominent global organizations such as the International Medical Device Regulators Forum (IMDRF), the International Council for Harmonisation (ICH) of pharmaceuticals, and Codex Alimentarius, which ensures global food safety standards. These partnerships significantly contribute to harmonizing local and international regulatory systems and standards, enhancing the quality of healthcare and food products both within Saudi Arabia and internationally.
The SFDA's regulatory role has notably expanded beyond its traditional functions of approving pharmaceuticals and medical devices. At the recent Global HealthSpan Summit held in Riyadh, Dr. Hisham Bin Saad Al-Jadhey, CEO of the Saudi Food and Drug Authority (SFDA), emphasized that the role of regulatory authorities has become increasingly comprehensive and influential. He explained that SFDA's responsibilities now extend beyond ensuring safety and efficacy to actively supporting innovation, adopting advanced health technologies, and regulating health practices that impact all aspects of the healthcare system.
A key component of these broader responsibilities is the growing emphasis on the role of nutrition in public health. Recognizing Saudi Arabia's high incidence of chronic diseases such as diabetes and obesity, the SFDA has launched several practical initiatives aimed at reducing these health challenges. These include implementing clear labeling of calorie content, restricting salt content, and minimizing sugar and trans fats in food products.
These initiatives are not limited to food alone but extend to incorporating modern health technologies into daily societal practices, significantly contributing to public health improvements and reducing hospital admissions related to chronic diseases.
Moreover, the SFDA plays a crucial role in stimulating investment and growth within the regulated sectors by creating a safe and efficient regulatory environment that encourages innovation and product development. Balancing safety, efficiency, and innovation not only fosters growth in local healthcare industries but also enhances Saudi Arabia's global reputation as a leading investment and health destination.
The importance of these developments is evident, as they significantly enhance Saudi Arabia's international standing and its attractiveness to global investors in the healthcare and food sectors. Furthermore, these advancements positively impact the national economy by creating new investment opportunities, generating high-quality jobs for citizens, and generally improving public health quality. Consequently, Saudi Arabia has become a global model in healthcare regulation and food and drug safety.
In conclusion, dear reader, the continuous and significant achievements of the SFDA underscore the ambitious vision adopted by the Kingdom to establish an advanced healthcare system based on global best practices, fundamentally aimed at enhancing the quality of life and ensuring public health and safety. These ongoing efforts solidify Saudi Arabia's position as a leader in healthcare at both regional and global levels.
Orange background

Try Our AI Features

Explore what Daily8 AI can do for you:

Comments

No comments yet...

Related Articles

SFDA Approves Elrexfio for Multiple Myeloma Treatment
SFDA Approves Elrexfio for Multiple Myeloma Treatment

Leaders

timea day ago

  • Leaders

SFDA Approves Elrexfio for Multiple Myeloma Treatment

The Saudi Food and Drug Authority (SFDA) has approved the registration of Elrexfio (Elranatamab) for adult patients with relapsed or refractory multiple myeloma who have undergone at least four prior lines of therapy. These previous treatments must have included a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody. Elrexfio has been granted orphan drug designation under the SFDA Orphan Drug Designation Program. How Elrexfio Works? Elrexfio contains Elranatamab, a bispecific antibody designed to target: BCMA – a protein found on multiple myeloma cells CD3 – a receptor on T-cells By binding to both targets, Elrexfio activates T-cells to release immune signals (cytokines) and directly destroy malignant myeloma cells. SFDA's decision followed a thorough evaluation of Elrexfio's efficacy, safety, and quality according to regulatory standards. Clinical trial data showed: 58% overall response rate in patients with relapsed or refractory multiple myeloma after at least four prior lines of therapy 82% of responders maintained their response for at least nine months Dosage, Administration Elrexfio is administered as a subcutaneous injection: Three step-up doses in the first week Once-weekly dosing up to Week 24 Once every two weeks thereafter Safety Profile The most common side effects observed in clinical studies included: Cytokine release syndrome (CRS) Injection site reactions Respiratory tract infections Musculoskeletal pain Fatigue Diarrhea Commitment to Rare Disease Treatment This approval reflects SFDA's commitment to improving access to therapies for rare and hard-to-treat conditions through the Orphan Drug Designation Program. In Saudi Arabia, a rare disease is defined as affecting fewer than 5 people per 10,000 in the population. For more details about the Orphan Drugs Guideline, visit: SFDA Orphan Drugs Guideline Or contact SFDA at: [email protected] Related Topics : SFDA Reports Record 82% Surge in Licensed Factories, Warehouses in 2024 Is wheat harmful to the intestine? SFDA clarifies the truth New Corona vaccines to arrive at the Kingdom: SFDA SFDA: National Biotechnology Strategy Highlights Saudi Leadership in Medical Innovation Short link : Post Views: 7 Related Stories

Delhi given eight weeks to round up thousands of stray dogs
Delhi given eight weeks to round up thousands of stray dogs

Saudi Gazette

time2 days ago

  • Saudi Gazette

Delhi given eight weeks to round up thousands of stray dogs

DELHI — India's top court has ordered authorities in Delhi and its suburbs to move all stray dogs from streets to animal shelters. The court expressed concerns over rising "menace of dog bites leading to rabies" and gave an eight-week deadline to officials to finish the task. Delhi's stray dog population is estimated at one million, with suburban Noida, Ghaziabad, and Gurugram also seeing a rise, municipal sources say. India has millions of stray dogs and the country accounts for 36% of the total rabies-related deaths in the world, according to the World Health Organization. "Infants and young children, not at any cost, should fall prey to rabies. The action should inspire confidence that they can move freely without fear of being bitten by stray dogs," legal news website Live Law quoted the court as saying on Monday. The court took up the issue following reports of increasing dog bites in Delhi and other major court directed that multiple shelters be established across Delhi and its suburbs, each capable of housing at least 5,000 dogs. These shelters should be equipped with sterilisation and vaccination facilities, as well as CCTV court ruled sterilised dogs must not be released in public areas, despite current rules requiring their return to the capture also ordered that a helpline should be set up within a week to report dog bites and rabies welfare groups, however, have voiced strong concerns over the court's directive. They said that the timeline set up by the court was unrealistic."Most Indian cities currently do not have even 1% of the capacity [needed] to rehabilitate stray dogs in shelters," said Nilesh Bhanage, founder of PAWS, a prominent animal rights group."If the court and the authorities actually want to end the menace, they should focus on strengthening the implementation of the existing regulations to control dog population and rabies — they include vaccination, sterilisation and efficient garbage management."Government data shows that there were 3.7 million reported cases of dog bites across the country in say the true extent of rabies-related deaths is not fully World Health Organization says that "the true burden of rabies in India is not fully known; although as per available information, it causes 18,000-20,000 deaths every year".On the other hand, according to data submitted in the parliament by the Indian government, 54 rabies deaths were recorded in 2024, up from 50 in 2023. — BBC

Indian top court orders roundup of stray dogs in Delhi
Indian top court orders roundup of stray dogs in Delhi

Arab News

time3 days ago

  • Arab News

Indian top court orders roundup of stray dogs in Delhi

NEW DELHI: India's Supreme Court on Monday ordered the removal of tens of thousands of stray dogs from the capital, citing public safety concerns after a surge in dog bites. India is home to millions of stray dogs and deadly attacks, particularly on children and the elderly, are regularly reported by the city's media. At least 60,000 stray dogs live on the streets of Delhi, according to India's Livestock Census of 2012, the most recent data available. Some suggest that number to be now far higher, with large rival dog packs patrolling parks and residential neighborhoods across the city. The country accounts for more than a third of global rabies deaths, according to the World Health Organization, a crisis exacerbated by a lack of sterilization programs and legal restrictions on canine culling. The court asked city authorities to set up dog shelters within eight weeks, and maintain daily records of the canines captured. 'What is important, and without which the entire exercise would go futile, not a single stray dog should be released,' it said, which applies to Delhi and its satellite suburbs, a megacity home to some 30 million people. The court warned of action against animal activists who obstruct the removal of dogs. It also ordered a 24-hour helpline to be set up to report dog bites and officials must publicize locations where anti-rabies vaccines are available. Data tabled in the Indian parliament showed more than 3.7 million cases of dog bites and 54 suspected human deaths from rabies in 2024. Other estimates peg the number to be nearly twice as high, with Delhi alone accounting for roughly 2,000 cases of dog bites every day. In middle class neighborhoods, many of Delhi's strays are beloved by their residents despite lacking formal owners, with some dogs clothed in special canine jackets to keep warm during the winter. But they are also a hazard to humans, with Indian media regularly reporting on the mauling of young children by aggressive dog packs.

DOWNLOAD THE APP

Get Started Now: Download the App

Ready to dive into a world of global content with local flavor? Download Daily8 app today from your preferred app store and start exploring.
app-storeplay-store