One of my company’s directors has a record of being penalised by another financial regulator (such as the Hong Kong Securities and Futures Commission, SFC). Will this affect the drug licence application?

This could very likely have a negative impact on a pharmaceutical licence application. Although the SFC regulates the financial sector, a different field from pharmaceutical regulation, the Pharmacy and Poisons Board (PPB), when assessing whether an applicant is a “fit and proper person”, will consider their integrity and conduct across all business and professional activities. A public reprimand or penalty by the SFC or another major regulatory authority, particularly for reasons involving dishonesty, misconduct or inadequate internal controls, would be viewed by the PPB as a significant warning sign. The PPB may be concerned that a director who failed to discharge fiduciary duties in the financial sector might also be careless in the pharmaceutical sector, which concerns public health. You must therefore proactively disclose the matter fully in your application and provide a detailed explanation.