The Health Sciences Authority (HSA) has introduced a Pandemic Special Access Route (PSAR) to facilitate early access to critical novel vaccines, medicines and medical devices during a pandemic, such as the current COVID-19 pandemic. Companies can only apply to HSA using PSAR for designated health products which the Government of Singapore requires during a pandemic.
2 An interim authorisation under PSAR would be considered, if:
- there is reasonable quality, safety and efficacy (QSE) data suggesting that the potential benefits outweigh the known risks when used during the COVID-19 pandemic; and
- there is continuing QSE data generated from ongoing studies to support the eventual transition of the interim authorisation to full registration
3 HSA’s PSAR interim authorisation is similar to the emergency authorisation framework currently adopted by other regulatory jurisdictions such as Canada, the United States and the United Kingdom.
Rolling data submission for speedier evaluation
4 Using PSAR, HSA can start evaluating new vaccines, medicines and medical devices from the early stages of clinical studies, as and when real-time data is submitted by companies on a “rolling”, or staggered basis, instead of waiting for the full data set to be submitted before starting our evaluation. This gives HSA more time to review the submitted data while companies continue with further clinical trials and development concurrently. The clinical trials have also been designed to be innovative and efficient, enabling the companies to conduct multiple trials concurrently, while maintaining the scientific rigour. Such regulatory agility and flexibility allow for speedier development and evaluation.
5 As with other new vaccines, medicines and medical devices, data submitted by companies under PSAR will be robustly and thoroughly reviewed by HSA’s regulators and international scientific standards will be applied during the evaluation. Although companies can start submitting data from the early development stages, HSA will only grant PSAR authorisation for the vaccine, medicine or medical device after the data accrued by the company has been assessed by HSA to demonstrate that it meets the required safety, efficacy and quality standards, and that the benefits outweigh the known risks. There should also be no significant adverse events, and relevant studies have to be submitted to HSA by the time the company applies for PSAR authorisation.
Continuous review of data
6 As a condition for the interim authorisation under PSAR, companies must continue submitting longer term follow up data to HSA to assure the continued effectiveness and safety of the vaccine. HSA will actively review the data to ensure that the benefits of the vaccine, medicine or medical device continue to outweigh the known risks. HSA may terminate PSAR authorisation at any time; for example, if new data suggests that the benefits no longer outweigh the risks.
Transition to full product registration
7 When sufficient data is available for full registration, companies will be required to file an application to transition the status of the product from PSAR interim authorisation to full registration.
8 For more technical information on the application for PSAR, refer to: https://www.hsa.gov.sg/therapeutic-products/register/special-access-routes/psar-emergency-therapeutic-product.
9 For more information on the PSAR for Medical Devices, refer to: https://www.hsa.gov.sg/medical-devices/registration/special-access-routes/PSAR-MD