HSA milestones

• The Health Sciences Authority (HSA) was established as a statutory board under the Ministry of Health on 1 April 2001 with the integration of five of its former national agencies:

  • Centre for Drug Evaluation

  • Institute of Science and Forensic Medicine

  • National Pharmaceutical Administration

  • Product Regulation Department

  • Singapore Blood Transfusion Service

• These five agencies were then reorganised into eight professional centres:

  • Centre for Pharmaceutical Administration (CPA)

  • Centre for Drug Evaluation (CDE)

  • Centre for Radiation Protection (CRP)

  • Centre for Medical Device Regulation (CMDR)

  • Centre for Transfusion Medicine (CTM)

  • Centre for Forensic Medicine (CFM)

  • Centre for Forensic Science (CFS)

  • Centre for Analytical Science (CAS)

• The blood donation suite of the Singapore Blood Transfusion Service, which was renamed as CTM, became known as the Bloodbank@HSA.

• The Singapore Red Cross was formally appointed as the National Blood Donor Recruiter in a Memorandum of Understanding (MOU).

• Controls for Chinese Proprietary Medicines (CPMs) were fully implemented. All CPMs had to be assessed before being marketed. Importers, wholesalers, and local manufacturers and assemblers of CPMs also had to be licensed.

• The Pharmaceutical Inspection Convention (PIC/S) Guide to Good Manufacturing Practice (GMP) for medical products was gazetted as the GMP standard for Singapore.

• Established an Online Adverse Event Reporting Programme for healthcare professionals.

• A national haemovigilance programme that was set up in collaboration with Hospital Transfusion Committees, greatly improved transfusion safety at hospitals.

• DonorCare@HSA, an Internet portal, was launched to offer greater convenience for donors, who could now make online appointments for blood donations.

• A newly renovated state-of-the-art Apheresis Suite@HSA was launched.

• Stepped up precautionary measures at Bloodbank@HSA as SARS crisis hit Singapore.

• CFM conducted autopsies on victims of the SARS outbreak.

• The DNA Database Laboratory was set up in collaboration with the Singapore Police Force (SPF), building a fully automated system for DNA samples of convicted offenders.

• The First Collective Agreement was signed with the Amalgamated Union of Statutory Board Employees (AUSBE), signalling the close ties between HSA Management and its staff union.

• CPA merged with CDE to form the Centre for Drug Administration (CDA).

• HSA’s forensic medicine and DNA profiling experts provided disaster victim identification (DVI) services during the Asian Tsunami Relief efforts.

• MOUs were signed with the People’s Republic of China’s State Food and Drug Administration and Australia’s Victorian Institute of Forensic Medicine.

• The Hepatitis B Virus Nucleic Acid Amplification Test screening for all donated blood was implemented. This was in addition to the existing Hepatitis C virus and HIV nucleic acid amplification test.

• A new pathway was introduced for the registration of Western drugs in Singapore. This verification route offered a shorter time to market.

• An online Singapore Medical Device Register to capture information on legally available devices and establishments dealing with such products was developed.

• An MOU was signed with the United States Food and Drug Administration.

• Graphic health warning labels on cigarette packets, the first of its kind in Asia, were implemented with the revised Smoking (Control of Advertisements and Sale of Tobacco) (Labelling) Regulations 2003.

• A Bio-Safety Level 4 Containerised Autopsy Facility for the handling of suspected highly infectious cases was commissioned.

• Bacterial testing was introduced for platelets, reducing the risk of bacterial contamination for patients receiving the products.

• MOUs were signed with Health Canada and the United States Pharmacopeia.

• The new Cell Processing Laboratory, a facility dedicated to translational cell therapy work was opened.

• Celebrations marked the 60th anniversary of the National Blood Programme.

• HSA was restructured into three professional groups:

  • CDA regrouped with two other centres, CMDR and CRP to form the Health Products Regulation Group (HPRG).

  • CTM was regrouped under the Health Services Group.

  • CAS, CFS and CFM were reorganised to form the Applied Sciences Group (ASG).

• The Health Products Bill was passed in Parliament on 12 February 2007 and brought into force on 1 November 2007.

• CRP was transferred to the National Environment Agency (NEA) and renamed as NEA’s Centre for Radiation Protection and Nuclear Science.

• An MOU was signed with Swissmedic, the Swiss Agency for Therapeutic Products.

• In February 2008, the administrative control and enforcement of the Contact Lens Practitioners Act and its regulations, which was previously administered by CDA, was transferred to the Ministry of Health.

• The ASEAN Cosmetics Directive on Cosmetic Control was implemented via the Health Products (Cosmetic Products — ASEAN Cosmetic Directive) Regulations 2007.

• Following an HSA organisation review, the Health Services Group was renamed the Blood Services Group (BSG).

• HSA was officially designated by the National Metrology Centre at the Agency of Science, Technology and Research as a Designated Institute for Chemical Metrology in the medical and pharmaceutical fields, as well as in the areas of food, healthcare and forensics.

• A new Chemical Metrology Division was established to develop capabilities in the designated areas and spearhead the chemical metrology programme.

• Collaborative investigations by HSA's regulatory and laboratory teams led to the quick detection of illegal aphrodisiac products such as Power 1 Walnut. This swift response earned a commendation at the Minister for Health Award Ceremony 2008.

• ASG was restructured into six specialised divisions, namely, Forensic Medicine, Forensic Science, Illicit Drugs and Toxicology, Pharmaceutical, Food Safety and Chemical Metrology.

• HSA’s Cell Therapy Facility was launched with the aim to become a leading academic facility for one-stop research and translational service for cell therapy in Southeast Asia.

• The HSA Professional Board was formed to advise and make recommendations on issues relating to professional staff development and professional excellence.

• MOUs were signed with Sweden’s Medical Products Agency and the United Kingdom’s Medicine and Healthcare Products Regulatory Agency.

• Forensic Science Division launched the region’s first vehicle paint database in collaboration with the Singapore Police Force

• The Forensic Science Division, ASG was further restructured to form the Forensic Science Division and Biology Division (which comprised the DNA Profiling and the DNA Database Laboratories).

• The Tobacco (Control of Advertisements and Sale) Act, enforced by the Tobacco Regulation Branch, was passed in Parliament to replace the Smoking (Control of Advertisements and Sale of Tobacco) Act.

• MOUs were signed with the Irish Medicines Board, Korea Food and Drug Administration, Korea National Forensic Service, New Zealand Medicines and Medical Devices Safety Authority, Germany’s Paul-Ehrlich Institut and Japan’s Pharmaceuticals and Medical Devices Agency.

• A Service Level Agreement was established with the Ministry of Home Affairs to strengthen the scientific scope and timeliness of our services in supporting the Home Team departments.

• An HSA Forensic Pathologist and a DNA scientist were part of Singapore’s five-member team to assist in disaster victim identification at earthquake-stricken Christchurch, New Zealand.

• The first fixed satellite blood collection centre, Bloodbank@Woodlands, was launched to make blood donation more convenient.

• Following the success of Bloodbank@Woodlands, another satellite centre at Dhoby Ghaut was opened.

• The Illicit Drugs and Toxicology Division, ASG was regrouped into Illicit Drugs Division and Analytical Toxicology Division respectively.

• The second DNA Profiling Laboratory opened in Synapse, Biopolis.

• MOUs were signed with two agencies in the Netherlands - the National Forensic Institute of the Netherlands and the Medicines Evaluation Board of the Netherlands.

• MOUs were also signed with the National University of Singapore’s Saw Swee Hock School of Public Health and the Ministry of Health, Malaysia.

• BSG introduced malaria antibody screening for at-risk units to increase blood safety and buffy-coat method for preparing platelets more efficiently.

• Divisions in ASG were further restructured into three areas: Forensic Medicine, Forensic Science and Analytical Science.

• In consultation with MOH, the ban on Chinese Proprietary Medicines containing berberine was lifted in a phased approach.

• A Service Level Agreement was established with the Agri-Food and Veterinary Authority to strengthen the scientific scope and timeliness of our services in supporting the national food safety programme.

• The Bloodbank@Westgate Tower opens to make blood donation more convenient for donors living in the west.

• Biology Division introduced rapid DNA analysis for crime scene samples.

• HSA and SPRING Singapore signed a Collaboration Memorandum to collaborate in the areas of supporting national standards and conformance infrastructure, and strengthening the dissemination of metrological traceability to local laboratories in August 2015.

• The 70th anniversary of the National Blood Programme was marked at the annual World Blood Donor Day.

• The transfer of regulatory controls of pharmaceutical products to the Health Products Act was completed.

• The ban on emerging tobacco products and shisha came into force.

• HSA expedited the approval of Dengvaxia, the first dengue vaccine, within six months.

• An MOU was signed with the Brazilian Health Regulatory Agency (ANVISA), Brazil.

• HSA implemented universal Zika Nucleic Acid Test screening on all blood donations.

• A MOU was signed with the Federal Commission for the Protection against Sanitary Risk (COFEPRIS), Mexico

• The Point-of-Sale Display Ban on tobacco products took effect from August.

• Biology Division, in collaboration with the Singapore Police Force, introduced the use of Y-chromosomal DNA analysis for enhanced detection of male perpetrators.

• The prohibition on the possession, purchase, or use of emerging and imitation tobacco products, which include electronic vaporisers kicked in.

• The ban on the Corydalis yanhusuo herb and Chinese Proprietary Medicines containing the naturally occurring substance tetrahydropalmatine was lifted.

• The Food Safety Division was transferred to the Singapore Food Agency under its National Centre for Food Science on 1 Apr.

• The minimum legal age for smoking was raised to 19, and will be progressively raised to 21 in 2021.

• Cosmetic products containing mercury were prohibited, in compliance with the Minamata Convention on Mercury.

• Standardised packaging with enlarged graphic health warnings was rolled out for all tobacco products.

• The Applied Sciences Group launched the Labware Laboratory Information Management System (LISA 2), successfully digitalising almost 80% of routine workflows/ processes and in a move towards a paperless environment.

HSA's COVID-19 RESPONSE

• The Forensic Medicine Division conducted autopsies on suspected, positive and post-COVID cases in special Bio-safety Level 4 autopsy suites.

• The COVID-19 Convalescent Plasma protocol for Singapore was established in collaboration with the National Centre for Infectious Diseases and Tan Tock Seng Hospital.

• HSA granted conditional approval for Remdesivir, the first evidence-based antiviral COVID-19 treatment in Singapore.

• The Pandemic Special Access Route (PSAR) was introduced to facilitate speedier access to critical vaccines, medicines and medical devices during the COVID-19 pandemic.

• HSA was the first in Asia to authorise Pfizer-BioNTech’s COVID-19 vaccine for pandemic use.

• HSA facilitated the import and production of surgical masks, particulate respirators and protective gear in Singapore during the pandemic.

• Subsidiary legislation to effect the implementation of cell, tissue and gene therapy products regulation was gazetted.

• HSA implemented a first-in-the-world expert system to automatically evaluate DNA Y-STR profiles.

• Hepatitis E testing of donated blood was included as part of our routine screening protocol.

• In September, HSA launched DonateBlood – a mobile app for blood donors. It is an extension of Donor Portal and allows donors to easily retrieve information and access services such as appointment booking, updating particulars, health assessment form and digital donor card.

• HSA extended the shelf life of platelets from five to seven days, and optimised the process to produce plasma-reduced platelets. 

HSA’s COVID-19 RESPONSE

• With the support from the Coroner’s Court and the Singapore Police Force, Forensic Medicine Division introduced an enhanced process to ensure safer transfer and handling of COVID-19 related deceased persons.

• HSA was the first in Asia to authorise Moderna’s COVID-19 vaccine (Spikevax) for pandemic use.

• HSA authorised two monoclonal antibody therapies, sotrovimab and casirivimab-imdevimab, for treatment of COVID-19 infections.

• HSA authorised the Sinovac-CoronaVac vaccine for pandemic use.

• HSA approved transition of Pfizer-BioNTech’s Comirnaty COVID-19 vaccine from PSAR interim authorisation to full registration.

• HSA authorised Pfizer-BioNTech’s Comirnaty COVID-19 vaccine to be extended to children aged 5-11 years.

• HSA launched the Audit Management System for GDP and retal pharmacy inspection to digitalise GDP and pharmacy audit-related work processes. 

• The Cell Processing Laboratory was renamed as the Cell & Gene Therapy Facility and underwent infrastructural modifications to incorporate new cell manufacturing capabilities. 

• An innovative DNA testing method was developed for cannabis plant material, which can provide >99% match to known cannabis references when tested. 

HSA’s COVID-19 RESPONSE

• HSA granted interim authorisation for COVID-19 vaccine, Nuvaxovid.

• HSA granted interim authorisation for Paxlovid, an oral anti-viral medicine for the treatment of COVID-19. 

• HSA initiated an intensive vaccine safety monitoring effort with an enhanced safety monitoring framework for COVID-19 vaccines..

• HSA granted interim authorisation under the PSAR for the following vaccines: Pfizer-BioNTech Comirnaty Bivalent (Original/Omicron BA.4/5), Moderna Spikevax Bivalent (Original/Omicron BA.1), Paediatric Moderna Spikevax (0.1mg/ml).

• HSA granted interim authorisation under the PSAR for the following anti-viral therapeutic medicines: Evusheld, Lagevrio.

• HSA granted product registration for a paediatric vaccine (Pfizer-BioNTech Comirnaty 3mcg/dose).

• HSA launched the first nation-wide Active Surveillance System For Adverse Reactions To Medicines And Vaccines (ASAR) application that analyses healthcare data and clinical notes from public acute hospitals to detect early safety signals and implement timely risk mitigation measures.

• HSA implemented real-time location tracking of blood and blood products by incorporating RFID chips in the blood labels.  

• The Bloodbank@One Punggol opens to serve the north-eastern region of Singapore.

• HSA developed multiple Reverse Transcription-digital polymerase chain reaction assays for the quantification of SARS-CoV-2 RNA in copy-based units, a new capability that would be useful in future pandemics.

• HSA signed a Memorandum of Understanding (MOU) with Poland’s Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (URPL) to kickstart cooperation between the two regulatory authorities.

• HSA revised restrictions on donors who previously lived in the variant Creutzfeldt-Jakob Disease- (vCJD) risk areas of France, Ireland and the United Kingdom, allowing them to donate via apheresis.

• The Biologics Laboratory began operations.

• HSA signed an MOU with the National Institute of Metrology, China, providing a framework for the exchange of knowledge and personnel to increase scientific and technical capabilities in addressing measurement issues.

• HSA was designated by WHO as a WHO Listed Authority.

HSA's COVID-19 RESPONSE

• HSA authorised the updated Spikevax vaccine by Moderna, and updated Comirnaty vaccine by Pfizer for use in individuals aged 6 months and above.

• Six PSAR interim authorisations for vaccines and therapeutics were transitioned to full registrations.

• HSA launched the Singapore Health Product Access and Regulatory E-System (SHARE), a one-stop digital portal for Cell, Tissue and Gene Therapy Products (CTGTP) Dealer’s Notice and Class 1 CTGTP notification. 

• HSA entered into a Mutual Recognition Agreement signed with the Republic of Korea’s Ministry of Food and Drug Safety on Good Manufacturing Practice for medicinal products. 

• HSA and the Ministry of Health, Malaysia signed an MOU for continued cooperation in matters pertaining to pharmaceutical products and cosmetics including post-market vigilance, enforcement and Good Clinical Practice for clinical trials. 

• HSA signed an MOU with Vietnam Metrology Institute (VMI) to strengthen collaboration in the areas of knowledge exchange, joint research and development of regional quality infrastructure.

• HSA implemented Next-Gen Blood Supply Management System across all public hospitals to enhance patient safety and improve productivity.