HSA is a multi-disciplinary agency. It applies medical, pharmaceutical and scientific expertise to protect and advance public health and safety. 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 - Bloodbank@HSA; and it represents the national expertise in forensic medicine, forensic science and analytical chemistry testing capabilities. These support other regulatory and compliance agencies in the administration of justice and in safeguarding public health.
The 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.
Today, the agency’s professional knowledge, skills and competencies are housed in 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 HQ that provides strategic direction and corporate support for advancing the organisation.
Health Products RegulationEdit
The HSA’s Health Products Regulation Group ensures that medicines, medical devices and other health products available in Singapore meet appropriate and acceptable standards in quality, safety and efficacy. The agency also contributes to the formulation of national drug policies.
HSA’s risk management system takes into account pre-and-post market precautionary options. On the pre-market front, HSA administers clinical trials 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.
On the post-market front, HSA monitors health products in the market through regulatory 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 monitoring programme that draws on its network of healthcare professionals and overseas regulators. This allows HSA to initiate targeted and prompt alert action in response to reported adverse drug events. This allows the agency to expedite the isolation of such problems and minimise harm to public health and safety.
In support of the national objective to reduce smoking, HSA enforces the laws that prohibit tobacco advertisements, smoking by youths under 18 years old as well as the sale of tobacco products to youths in this age group.
National Blood ServiceEdit
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, 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 screening criteria, a reliable battery of tests that is conducted on all collected blood, and a strong quality system.
The HSA has maintained a strategic partnership with the Singapore Red Cross since 2001 in managing the National Blood Donor Recruitment and Retention Programme. In 2007, about 55,000 individuals came forward to make blood donations.
The agency is the reference centre for immunohaematology, tissue typing and transfusion medicine in the country. It offers immunohaematology services and tissue typing services to healthcare institutions in Singapore and the region. It also provides clinical consultative services in the speciality of transfusion medicine. In recent years, it has embarked on the development of a Cell Processing Laboratory to support the new area of clinical cell therapy.
Forensic and Analytical Sciences ExpertiseEdit
HSA’s Applied Sciences Group represents Singapore’s national expertise in forensic medicine, forensic sciences, analytical scientific capabilities as well as the new developing area of metrology in chemistry. This Group supports other regulatory and compliance agencies in the administration of justice and safeguarding public health. The Group comprises: Forensic Medicine Division, Forensic Science Division, Illicit Drugs and Toxicology Division, Pharmaceutical Division, Food Safety Division and Chemical Metrology Division.
The range of services cover forensic medical consultancy services in support of death investigation in Singapore; forensic science services such as criminalistics 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 regulation. Toxicological services are also provided to hospitals.
In collaboration with the Agency for Science, Technology and Research (A*STAR), HSA has been a designated institute for chemical metrology in Singapore since 2008.
International Alliances, Affiliations and Collaborative EffortsEdit
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, Health Canada, Swiss Medic, the Australian Therapeutic Goods Administration and the Chinese State Food and Drug Administration.
HSA’s competencies have been recognised by international bodies such as the World Health Organisation (WHO). Its 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.
For its forensic medicine and forensic sciences capabilities, HSA has received endorsements from various established global agencies. 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 International Drug Control Programme Reference Laboratory for Biological Specimens and Seized Materials.