1. This guidance outlines the emergency use pathway through Provisional Authorisation for unregistered therapeutic products (TP). The Provisional Authorisation is intended to facilitate availability of critical therapeutics and vaccines for treating or preventing serious or life-threatening diseases in an emergency that may pose serious threats to public health, and such emergency situation cannot be managed appropriately by any means other than the use of the said therapeutics or vaccines.
2. This pathway provides an interim authorisation for use of an unregistered TP during emergency to allow fast access under the specified conditions, as below:
a) There is preliminary evidence-based data suggesting that the efficacy outweighs the risk of the TP when used in emergency situation; and
b) The product is intended for use in a specified healthcare institution in Singapore and the application for provisional authorisation is upon the request of the said healthcare institution.
3. The documentary requirements for application filing are as below:
a) A declaration by the manufacturer that the manufacturing is compliant with GMP;
b) A summary of the drug product (DP) manufacturing process, formula, specification and the Certificate of Analysis (CoA) of the batch to be brought in;
c) A summary of efficacy and safety data from on-going/completed clinical trials; and
d) An undertaking by the applicant company to implement safety monitoring measures and notify HSA immediately where there is new information that may impact the benefit-risk of the TP.
4. HSA may cancel a Provisional Authorisation if the threat of the emergency situation to public health abates and the unregistered TP is no longer required to address an urgent medical need in Singapore.
5. For application submission, please email HSA_TP_Enquiry@hsa.gov.sg