This guidance outlines the special access route for the supply of an “emergency therapeutic product” through an interim authorisation under sub-regulations 60A(4) and (5)(b) of the Health Product (Therapeutic Products) Regulations.
The interim authorisation enables regulatory agilities in responding to an emergency that may pose serious threats to the public such as in the situation of a pandemic. Given the urgent public health need, HSA will prioritise the review of novel therapeutics and vaccines to facilitate timely access while ensuring the scientific rigour of the assessment of their quality, safety and efficacy.
PSAR provides for the Government of Singapore to direct the supply of such emergency therapeutic products during the pandemic, taking into consideration the following:
a) there is reasonable evidence suggesting that the potential benefits outweigh the risks for their use in treating or preventing a disease in an emergency that may pose serious threats to the public; and
b) there is on-going quality, safety and efficacy data generated to support the eventual transition of the interim authorisation to product registration under section 15 of the Health Products Act and regulation 22 of the Regulations.
2.Emergency Therapeutic Product
A novel therapeutic or vaccine may be designated by the Health Minister as an “emergency therapeutic product” where:
a) the therapeutic product is needed —
i. to treat any medical condition resulting from a civil defence emergency;
ii. to prevent the spread or possible outbreak of an infectious disease; or
iii. to treat an infectious disease or any medical condition associated with an infectious disease,
where the medical condition or infectious disease is potentially serious or life-threatening; and
b) in the opinion of the Health Sciences Authority, there is —
i. preliminary scientific evidence that the therapeutic product has the potential —
- to treat the medical condition resulting from the civil defence emergency;
- to prevent the spread or possible outbreak of the infectious disease; or
- to treat the infectious disease or any medical condition associated with the infectious disease,
ii. ongoing scientific evidence that the potential benefits of the therapeutic product outweigh the known risks of the therapeutic product.
3.Prerequisite Criteria and Requirements for an Emergency Therapeutic Product Application
a) Prerequisite criteria
Before making an application under the interim authorisation, the applicant must ensure that it fulfils the prerequisite criteria below:
i. The applicant is a supplier directed by the Government of Singapore to supply for or on behalf of the Government, thereafter referred to as the company; and
ii. The therapeutic product has been assessed by the Government of Singapore to have fulfilled one of more of the conditions specified in paragraph 2(a).
b) Pre-submission consultation
The company must notify HSA prior to making an application and arrange for a pre-submission consultation to discuss the data submission plan.
HSA will not accept any request for pre-submission consultation if the prerequisite criteria specified in paragraph 3(a) are not fulfilled. No reply will be given to such indiscriminate requests.
c) Data requirements
The interim authorisation provides flexibility in the level of evidence required for supporting the application and allows data to be submitted on a rolling basis. At the time of application, the company:
The interim authorisation is valid for such time during the emergency and may be cancelled if any of the following occurs:
when evolving quality, safety and efficacy data suggests that the benefits of the emergency therapeutic product no longer outweigh the risks during an emergency;
when the emergency has ceased; or
when there is adequate quality, safety and efficacy data to support a registration application and transition the emergency therapeutic product to a registered therapeutic product.
Post-authorisation amendments or updates to the dossier are to be submitted and approved prior to implementation.
The rolling submission will be reviewed based on real-time evaluation of data as and when the information is submitted to HSA. The turnaround time will depend on the rolling submission timelines as proposed by the company.
You will be notified of the outcome of your application via email.
How to apply
a. Pre-Submission Consultation:
Submit your request for a pre-submission consultation using the Online Request form for Pre-Submission Consultation.
Note: HSA will not accept any request for pre-submission consultation if the prerequisite criteria specified in paragraph 3(a) are not fulfilled. No reply will be given to such indiscriminate requests.
b. Filing a PSAR Application:
A company that has completed the steps specified in paragraph 3 (a), (b), and (c) may proceed to apply for an interim authorisation.
Submit your PSAR application using the Online Application form for PSAR Application.
c. Filing a PSAR Amendment Application:
Submit post-authorisation amendments or updates to the dossier using the Online Application form for PSAR Update/Amendment Application.
Ensure you have the following credentials before you access the e-service:
Changes cannot be made to the application form once submitted.