Snapshot

The Pandemic Special Access Route (PSAR) pathway has been developed by the of Singapore.

This pathway can be used where emergency therapeutic products.

This pathway accelerates the regulatory review process.

It is an abridged review (a reliance pathway).

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 the 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. 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. The turnaround time will depend on the rolling submission timelines as proposed by the company. Applicants will be notified of the outcome of their application via email. 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.