A director of the company was previously bankrupt, but has now been discharged from bankruptcy. Will this affect the company’s application for a drug licence?

This is an issue that needs to be handled carefully. A director’s history of bankruptcy is one of the factors that regulatory authorities may consider when assessing whether they are a “fit and proper person”, as it may reflect their financial management ability and business judgement. However, if the director has been formally discharged from bankruptcy and can provide a certificate of discharge issued by the court, the negative impact will be greatly reduced. In this situation, it is important to explain the matter to the regulatory authorities proactively and clearly. The application documents should include a statement explaining the reason for the bankruptcy (for example, whether it resulted from a sudden change in market conditions rather than personal misconduct), when it occurred, and how the director handled their financial obligations during and after the bankruptcy. Demonstrating that the incident was a one-off, has been properly resolved and has provided the director with lessons is key to reassuring the regulatory authorities.