Conditional Approval of Registration of Remdesivir

On 17 July 2020, the Pharmacy and Poisons (Registration of Pharmaceutical Products and Substances: Certification of Clinical Trial/Medicinal Test) Committee (“the Committee”) established under the Pharmacy and Poisons Board (“the Board”) conditionally approved the registration of Veklury (containing the active ingredient Remdesivir) which the holder of Certificate of registration is Gilead Sciences Hong Kong Limited (“Gilead”). Drug Office of Department of Health is responsible for providing professional and executive support to the Board and its Committee.

To expedite the registration approval of pharmaceutical product for COVID-19, the Committee held an ad-hoc meeting to evaluate the related application. The Committee considered that in view of the public health emergency under the COVID-19 pandemic, the local unmet medical need and there is no other registered pharmaceutical product indicated for use for the treatment COVID-19, the benefits of the use of Remdesivir in the treatment of COVID-19 outweigh the risks even though the data on its efficacy and safety is very limited at the time being and hence conditionally approved the application for registration. As part of the conditional approval of registration, Gilead is still required to submit additional safety, efficacy and quality data through on-going clinical studies and post-marketing report to the Drug Office of Department of Health according to the conditions imposed by the Committee.