Health Sciences Authority
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The Health Sciences Authority (HSA) is a statutory board under the Ministry of Health of the
Government of Singapore The Government of Singapore is defined by the Constitution of Singapore to mean the executive branch of the state, which is made up of the president and the Cabinet. Although the president acts in their personal discretion in the exercise ...
. It is a multi-disciplinary agency, responsible for applying medical, pharmaceutical and scientific expertise to protect and advance
public health Public health is "the science and art of preventing disease, prolonging life and promoting health through the organized efforts and informed choices of society, organizations, public and private, communities and individuals". Analyzing the det ...
and
safety Safety is the state of being "safe", the condition of being protected from harm or other danger. Safety can also refer to risk management, the control of recognized hazards in order to achieve an acceptable level of risk. Meanings There are ...
. The organisation serves three key functions: it is the national regulator for health products; it secures the national blood supply through its operation of the national
blood bank A blood bank is a center where blood gathered as a result of blood donation is stored and preserved for later use in blood transfusion. The term "blood bank" typically refers to a department of a hospital usually within a Clinical Pathology laborat ...
and management of
transfusion medicine Transfusion medicine (or transfusiology) is the branch of medicine that encompasses all aspects of the transfusion of blood and blood components including aspects related to hemovigilance. It includes issues of blood donation, immunohematology ...
standards; and it represents the national expertise in
forensic medicine Forensic medicine is a broad term used to describe a group of medical specialties which deal with the examination and diagnosis of individuals who have been injured by or who have died because of external or unnatural causes such as poisoning, assa ...
,
forensic science Forensic science, also known as criminalistics, is the application of science to criminal and civil laws, mainly—on the criminal side—during criminal investigation, as governed by the legal standards of admissible evidence and criminal ...
and
analytical chemistry Analytical chemistry studies and uses instruments and methods to separate, identify, and quantify matter. In practice, separation, identification or quantification may constitute the entire analysis or be combined with another method. Separati ...
testing capabilities. These support other regulatory and compliance agencies in the administration of justice and in safeguarding public health.


History

HSA was formed on 1 April 2001 with the integration of five specialised agencies under the Ministry of Health: the Centre for Drug Evaluation; Institute of Science and Forensic Medicine; National Pharmaceutical Administration; Product Regulation Department; and Singapore Blood Transfusion Service. On 1 April 2019, HSA's food-related duties were absorbed by its successor
Singapore Food Agency The Singapore Food Agency (SFA) is a statutory board under the Ministry of Sustainability and the Environment that oversees food safety and security in Singapore. History The agency was first announced on 26 July 2018 as a consolidation of all ...
(SFA) which also absorbed the food-related duties of two other statutory boards namely
Agri-Food and Veterinary Authority of Singapore The Agri-Food and Veterinary Authority of Singapore (AVA) was a statutory board under the Ministry of National Development that regulated food safety, safeguarded animal and plant health, and facilitated the agri-food and fisheries trade secto ...
(AVA) and
National Environment Agency National Environment Agency (NEA) is a statutory board under the Ministry of Sustainability and the Environment of the Government of Singapore. NEA is responsible for improving and sustaining clean and green environment in Singapore. Its r ...
(NEA). SFA is a statutory board under the
Ministry of the Environment and Water Resources The Ministry of Sustainability and the Environment (MSE; ms, Kementerian Kemampanan dan Sekitaran; zh, 永续发展与环境部; ta, நீடித்த நிலைத்தன்மை, சுற்றுப்புற அமைச்ச ...
. In February 2022, the HSA became the first regulatory authority in the world to attain the highest maturity level (ML 4) in the
World Health Organization The World Health Organization (WHO) is a specialized agency of the United Nations responsible for international public health. The WHO Constitution states its main objective as "the attainment by all peoples of the highest possible level of h ...
's classification of regulatory authorities for medical products. This affirms it as one of the leading regulators at ensuring the quality, safety and efficacy of medical products. Today, the agency comprises three professional groups: the Health Products Regulation Group; Blood Services Group, and Applied Sciences Group. Each group functions as Divisions comprising branches, units and laboratories. The three professional groups work with the Corporate Services Group which provides strategic direction and corporate support in advancing the organisation.


Role


Health products regulation

The Health Products Regulation Group ensures that
medicines A medication (also called medicament, medicine, pharmaceutical drug, medicinal drug or simply drug) is a drug used to diagnose, cure, treat, or prevent disease. Drug therapy (pharmacotherapy) is an important part of the medical field and rel ...
, innovative therapeutics,
medical devices A medical device is any device intended to be used for medical purposes. Significant potential for hazards are inherent when using a device for medical purposes and thus medical devices must be proved safe and effective with reasonable assura ...
and health-related products are wisely regulated and meet appropriate safety, quality and
efficacy Efficacy is the ability to perform a task to a satisfactory or expected degree. The word comes from the same roots as ''effectiveness'', and it has often been used synonymously, although in pharmacology a pragmatic clinical trial#Efficacy versu ...
standards. The agency also contributes to the development of biomedical sciences in Singapore by administering a robust, scientific and responsive regulatory framework. HSA's risk management system takes into account pre-and-post market precautionary options. On the pre-market front, HSA administers
clinical trials Clinical trials are prospective biomedical or behavioral research studies on human participants designed to answer specific questions about biomedical or behavioral interventions, including new treatments (such as novel vaccines, drugs, dietar ...
for new drugs and grants approvals for these products before they are marketed in Singapore. Audits on good manufacturing and distribution practices are also conducted. Regulation group would evaluate the medical device to determine whether it's acceptable to enter market. The medical device is classified as 4 levels according the product risk from Class A to Class D. On the post-market front, HSA monitors health products in the market through regular surveillance activities. The agency also carries out investigations and takes enforcement action against illegal activities related to unregistered, counterfeit and adulterated health products. HSA has an established and active
pharmacovigilance Term Given By Tushar Sharma (UPES Batch 2025) Pharmacovigilance (PV, or PhV), also known as drug safety, is the pharmaceutical science relating to the "collection, detection, assessment, monitoring, and prevention" of adverse effects with pharma ...
programme that draws on its network of healthcare professionals and overseas regulators. This allows HSA to initiate targeted and prompt action in response to reported adverse drug reports and expedite the isolation of such problems and minimise harm to public health and safety. In support of the national objective to reduce
smoking Smoking is a practice in which a substance is burned and the resulting smoke is typically breathed in to be tasted and absorbed into the bloodstream. Most commonly, the substance used is the dried leaves of the tobacco plant, which have bee ...
, HSA enforces the laws that prohibit
tobacco Tobacco is the common name of several plants in the genus '' Nicotiana'' of the family Solanaceae, and the general term for any product prepared from the cured leaves of these plants. More than 70 species of tobacco are known, but the ...
advertisements, smoking by youths under 21 years old as well as the sale of tobacco products to youths in this age group, as well as banning sales of emerging tobacco products such as
hookah A hookah (Hindustani language, Hindustani: (Nastaleeq), (Devanagari), IPA: ; also see #Names and etymology, other names), shisha, or waterpipe is a single- or multi-stemmed instrument for heating or vaporizing and then smoking either tobacco ...
and
electronic cigarette An electronic cigarette is an electronic device that simulates tobacco smoking. It consists of an atomizer, a power source such as a battery, and a container such as a cartridge or tank. Instead of smoke, the user inhales vapor. As such ...
s.


National blood service

The Blood Services Group is the national blood service of Singapore and is responsible for the adequacy and safety of the country's blood supply. It runs the Bloodbank@HSA in Outram, as well as three satellite blood banks – Bloodbank@Woodlands, Bloodbank@DhobyGhaut and Bloodbank@WestgateTower – which collects, processes, tests and distributes blood and blood components to all hospitals in Singapore. The agency has established a framework to ensure that there is a steady supply of safe blood for day-to-day needs at hospitals and during emergencies. The framework covers the recruitment of voluntary non-remunerated blood donors, stringent
blood donation A blood donation occurs when a person voluntarily has blood drawn and used for blood transfusion, transfusions and/or made into biopharmaceutical medications by a process called Blood fractionation, fractionation (separation of whole blood com ...
screening criteria, a reliable battery of tests that is conducted on all collected blood, and a comprehensive quality system benchmarked against stringent internationally recognised standards. The HSA has maintained a strategic partnership with the
Singapore Red Cross The Singapore Red Cross (SRC), formally the Singapore Red Cross Society, is a humanitarian aid and community services charity in Singapore. The SRC is a national member of the Federation of Red Cross and Red Crescent Societies (IFRC) and Interna ...
since 2001 in managing the National Blood Donor Recruitment and Retention Programme. The agency offers immunohaematology services and tissue typing services to local and regional healthcare institutions, as well as clinical consultative services in the specialty of transfusion medicine. In addition, the agency's cell therapy facility enables one-stop access to cell manufacturing and clinical trial implementation, blood processing and testing services.


Forensic and analytical sciences expertise

HSA's Applied Sciences Group represents Singapore's national expertise in forensic medicine, forensic sciences, analytical scientific capabilities as well as chemical
metrology Metrology is the scientific study of measurement. It establishes a common understanding of units, crucial in linking human activities. Modern metrology has its roots in the French Revolution's political motivation to standardise units in Fran ...
. This Group supports other regulatory and compliance agencies in the administration of justice and safeguarding public health. The Group comprises: Analytical Science (Chemical Metrology, Food Safety, and Pharmaceutical Divisions), Forensic Medicine and Forensic Science (Biology, Forensic Chemistry & Physics, Illicit Drugs and Analytical Toxicology Divisions). The range of services cover forensic medical consultancy services in support of death investigation in Singapore; forensic science services such as
criminalistics Forensic science, also known as criminalistics, is the application of science to criminal and civil laws, mainly—on the criminal side—during criminal investigation, as governed by the legal standards of admissible evidence and crimina ...
and DNA profiling in support of criminal investigations and illicit drugs control; analytical testing in support of health products regulation, cigarette and tobacco product control; water testing; and food safety testing. Toxicological services are also provided to hospitals. In collaboration with the
Agency for Science, Technology and Research The Agency for Science, Technology and Research (A*STAR) is a statutory board under the Ministry of Trade and Industry of Singapore. The agency supports R&D that is aligned to areas of competitive advantage and national needs for Singapore. ...
(A*STAR), HSA has been a designated institute for chemical metrology in Singapore since 2008.


International alliances, affiliations and collaborative efforts

HSA has established strong collaborations through Memoranda of Understanding (MOU) with international partners. This is part of its commitment to enhance inter-agency regulatory efforts on the global front. Its international partners include agencies such as the
US Food and Drug Administration The United States Food and Drug Administration (FDA or US FDA) is a federal agency of the Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the control and supervision of food s ...
,
Health Canada Health Canada (HC; french: Santé Canada, SC)Health Canada is the applied title under the Federal Identity Program; the legal title is Department of Health (). is the Structure of the Canadian federal government#Departments, with subsidiary unit ...
, Swissmedic, the Australian
Therapeutic Goods Administration The Therapeutic Goods Administration (TGA) is the medicine and therapeutic regulatory agency of the Australian Government. As part of the Department of Health and Aged Care, the TGA regulates the quality, supply and advertising of medicines, pa ...
and China Food and Drug Administration. HSA's professional groups have been identified as WHO Collaborating Centres in three core areas of expertise - Transfusion Medicine, Drug Quality Assurance and Food Contaminants Monitoring. HSA has been internationally accredited by the AABB (formerly known as the American Association of Blood Banks), and also the American Society of Histocompatibility & Immunogenetics. It is a founding member of the Asian Pacific Blood Network. As a WHO Collaborating Centre, the agency is an appointed Regional Quality Management Training Centre for Blood Transfusion Services. It is the first agency outside of the United States of America to be accredited by the National Association of Medical Examiners (NAME), and it also accredited by the American Society of Crime Laboratory Directors/Laboratory Accreditation Board, and the Singapore Laboratory Accreditation Scheme (SINGLAS). The agency is also a
United Nations The United Nations (UN) is an intergovernmental organization whose stated purposes are to maintain international peace and international security, security, develop friendly relations among nations, achieve international cooperation, and be ...
International Drug Control Programme Reference Laboratory for Biological Specimens and Seized Materials.


References


External links


Official site
{{Authority control 2001 establishments in Singapore Government agencies established in 2001 Statutory boards of the Singapore Government Medical and health organisations based in Singapore Organizations established in 2001 Regulation in Singapore