Pandemic Special Access Route (PSAR)

HSA introduced Pandemic Special Access Route (PSAR) so Singapore will have an easier time accessing critical novel vaccines, medicines, and medical devices during times of pandemic. PSAR is an interim authorization and would only be considered if: (1) the quality, safety, and efficacy (QSE) is reasonably within the data suggesting that the potential benefits outweigh the risks, and (2) there is a continuing QSE data that is being generated from ongoing studies as a support for when the authorization transits from interim to full.

Using this route, the authority can review novel vaccines, medicines, and medical devices, using data from early stages of clinical trials, with the real-time data submitted by parts instead of waiting for the full data to expedite the process. However, HSA evaluators will still subject the applications to very thorough reviews based on international scientific standards. Authorizations will be granted only to those products that comply with QSE and were the known benefits outweigh the risks and there should be no significant adverse event. Applicants must also continue submitting fresh follow–up data to comply with the QSE. On this note, HSA has the right to terminate the PSAR authorization when the risks outweigh the benefits as suggested by the new data. If there is sufficient data, applicants will be required to apply for full registration as a transition from the interim authorization.

PSAR for Supply of Emergency Therapeutic Products

Emergency therapeutic products can be granted PSAR authorizations provided that the emergency may pose serious threats to the public such as a pandemic. These products include vaccines, and the authority will prioritize the facilitation of timely access based on their QSE compliance. As per HSA, Emergency therapeutic products are needed:

(1) to treat any medical condition resulting from a civil defense emergency

(2) to prevent the spread or possible outbreak of an infectious disease

(3) to treat an infectious disease or any medical condition associated with infectious disease.

Prerequisite criteria for the application of therapeutic products include: (1) the applicant is a supplier on behalf of the Singaporean government, referred to as the company, and (2) the product meets the requirements mentioned above. Pre-submission consultation will also be done and must notify the HSA prior to making an application to discuss the submission plan. Consultation requests will not be entertained if the prerequisites are not met. Data requirements include (1) sufficient initial data to initiate the review process, and (2) a submission plan including the sequence and timelines of the fresh data submission.

The application may then be submitted provided that the aforementioned points are met. Submissions will be evaluated based on the incoming fresh data via real–time. The turnaround time is dependent on the submitted timeline by the company. The PSAR authorization will be valid during the emergency and may be canceled if: (1) the QSE data suggests the risks now outweigh the benefits, (2) the emergency has stopped, and (3) the collected data is now sufficient for full-fledged product registration.

Pandemic Special Access Route

Pandemic Special Access Route (PSAR) for Supply of Emergency Therapeutic Products