HSA's Regulatory Information and Consumer Advisories on COVID-19

You can find the latest COVID-19 related guidances, advisories, updates and general information for dealers, healthcare professionals and consumers on this page. 

General Updates

Vaccines

HSA authorises the updated Spikevax vaccine by Moderna targeting Omicron subvariants
HSA authorises the updated Comirnaty vaccine by Pfizer targeting Omicron subvariants
HSA authorises the use of Comirnaty COVID-19 vaccine by Pfizer in young children aged 6 months through 4 years
HSA grants interim authorisation for first bivalent COVID-19 booster vaccine in Singapore
HSA extends the use of Spikevax COVID-19 vaccine by Moderna to the younger population aged 6 months to 17 years old
HSA grants interim authorisation for Nuvaxovid COVID-19 vaccine by Novavax in Singapore
HSA extends the use of Comirnaty COVID-19 Vaccine by Pfizer-BioNTech to children of ages 5 to 11
HSA grants interim authorisation for Sinovac-CoronaVac vaccine in Singapore
HSA approves “Comirnaty” as the new brand name for Pfizer-BioNTech's COVID-19 vaccine
HSA approves “Spikevax” as the new brand name for Moderna's COVID-19 vaccine
HSA approves new storage condition for the Pfizer-BioNTech COVID-19 vaccine at refrigerator temperature for up to 31 days
HSA extends the use of Pfizer-BioNTech COVID-19 vaccine to adolescents of ages 12 to 15
HSA safety update on COVID-19 vaccines
Approval of updated storage condition for the Pfizer-BioNTech COVID-19 vaccine
HSA grants interim authorisation for Moderna COVID-19 vaccine in Singapore
HSA’s Pandemic Special Access Route (PSAR) facilitates Singapore's access to critical novel vaccines, medicines and medical devices
How COVID-19 vaccine development and Pandemic Special Access Route (PSAR) interim authorisation have expedited access to vaccines
HSA grants interim authorisation for first COVID-19 vaccine in Singapore
Factsheets for healthcare professionals and vaccine recipients


Medical Devices

HSA grants provisional authorisation for ‘BreFence Go COVID-19 Breath Test System’ and ‘TracieX Breathalyser’ for detection of COVID-19 infection
HSA grants interim authorisation for four COVID-19 antigen rapid test self-test kits
List of surgical masks manufactured by local licensed manufacturers

 

Others

HSA grants interim authorisation for Evusheld for pre-exposure prevention of COVID-19 in adults who are medically unsuitable for vaccination
HSA grants interim authorisation for LAGEVRIO (Molnupiravir) for treatment of COVID-19 infection
HSA grants interim authorisation for Paxlovid™, the first oral medicine for treatment of COVID-19 infection
HSA grants interim authorisation for casirivimab and imdevimab for treatment of COVID-19 infection
HSA grants interim authorisation for Sotrovimab for treatment of COVID-19 infection
HSA grants conditional approval of Remdesivir for treatment of COVID-19 infection 
Collaborations with ICMRA (International Coalition of Medicines Regulatory Authorities 

 

For Consumers

HSA's review of Swiss study that reported heart injury associated with COVID-19 mRNA vaccine
HSA's advisory on factors that may affect accuracy of COVID-19 antigen rapid self-test kit results
HSA updates on recent US FDA announcements about certain COVID-19 antigen rapid self-test kits
HSA advisory on Lianhua Qingwen products for prevention or treatment of COVID-19
Advisory on the use of ivermectin for COVID-19
COVID-19 self-test kits authorised for use in Singapore
What you need to know about masks
COVID-19 vaccine side effect self-reporting form
Advisory on herbal products claiming to prevent or treat COVID-19
Proper use and storage of alcohol-based hand sanitisers
Advisory on products claiming to prevent or treat COVID-19
Guide to masks and respirators

 

For the Industry

COVID-19 test kits authorised for professional use
Guidance on the import of surgical masks, hand sanitisers, respirators, thermometers and protective gear
Guidance on the supply of respiratory devices
Guidance on 3-D printing of essential medical devices and accessories for use in COVID-19 situation
Guidance on medical devices for decontamination of single use respirators during the COVID-19 situation
HSA CEO messages on facilitating development and access to COVID-19 related therapeutic products and devices

 

For Healthcare Professionals

Dear Healthcare Professional Letter - PSAR interim authorisation of Lagevrio (molnupiravir) for COVID-19 treatment
Dear Healthcare Professional Letter - PSAR interim authorisation of CoronaVac for active immunisation to prevent COVID-19 disease in Singapore
Dear Healthcare Professional Letter - PSAR interim authorisation of casirivimab and imdevimab infusion for COVID-19 infection in Singapore
Dear Healthcare Professional Letter - Interim authorisation of sotrovimab infusion for COVID-19 infection in Singapore
Special Access Route (SAR) for unauthorised COVID-19 vaccines
Dear Healthcare Professional Letter - Interim authorisation of Pfizer-BioNTech COVID-19 Vaccine extended to include use in adolescents aged 12 to 15 years

Dear Healthcare Professional Letter - Interim authorisation of Moderna COVID-19 vaccine for active immunisation to prevent COVID-19 disease in Singapore

Dear Healthcare Professional Letter - Monitoring the safety profile of COVID-19 vaccines

Dear Healthcare Professional Letter - Interim authorisation of Pfizer-BioNTech COVID-19 vaccine (BNT162b2) for active immunisation to prevent COVID-19 disease in Singapore
Report vaccine adverse events

 

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