The Health Sciences Authority (HSA) Singapore has published the updated guidance document on the regulatory processes and requirements for therapeutic product registration in August 2022.
HSA has updated the details on pre-submission consultation, whereby the range of mechanisms available to companies is explained in detail. This includes guidelines, flowcharts, frequently asked questions (FAQs) and self-help tools.
Companies or applicants are required to provide certain documents along with the request for a pre-submission meeting, such as proposed agenda and the exact issue that will be discussed. An overview of the process has been shared in the updated guideline.
More details can be found in “Guidance on Therapeutic Product Registration in Singapore, August 2022”: https://www.hsa.gov.sg/docs/default-source/hprg-tpb/guidances/guidance-on-therapeutic-product-registration-in-singapore_aug22.pdf