Effective from June 2020 onward the Health Sciences Authority, Singapore will be publishing the Summary Reports of Benefit-Risk Assessments for new biological and chemical entities. The pilot initiative will boost transparency with stakeholders and the public. The publication of the Summary Reports of Benefit-Risk Assessment for regulatory approvals is aligned with the best practices of global regulatory agencies.
Among the information included in the summary are safety, efficacy, and quality data, and HSA’s conclusion drawn from the benefit-risk balance analysis.Confidential/proprietary information is excluded.
Prior to the publication of the summary report on the HSA website, the product registrants will receive the said copy of the summary report.
Due to this being a pilot initiative, HSA will continuously fine-tune and review and make necessary adjustments as more experience is gathered.
For more information, please refer to https://www.hsa.gov.sg/docs/default-source/hprg-tpb/industry-comms/summary-report-and-registration-conditions-update.pdf