Singapore HSA Updates Guidance TPB-GN-004-005 regarding the Import and Supply of an Unregistered Therapeutic Product For Patients’ Use.
HSA includes the conditions for using the “named-patient” special access route as following:
a) The clinician must obtain and document informed consent from the patient or patient’s guardian for the use of the unregistered therapeutic product on the patient;
b) The clinician must furnish a declaration that the use of the unregistered therapeutic product complies with the Ministry of Health’s allowable practice and applicable law;
c) The clinician must furnish a declaration that the use of the unregistered therapeutic product complies with the clinical practice allowed under the Singapore Medical or Dental Council’s Ethical Code and Ethical Guidelines
In addition, the guidance also added a subsection on Documentary Requirements for Investigational Therapies.
Consequently, the relevant application forms (i.e. Signed Request form for Named-Patient Application Type and Signed Request Form for Buffer Stock Application Type) are also updated.
For reference to the updated guidance and forms, please refer to the following weblink: https://www.hsa.gov.sg/therapeutic-products/guidance-documents