When applying for pharmaceutical licences, what specific requirements do regulators have regarding the “integrity” and character of an applicant or company director?

The regulatory authority has very high expectations of the integrity and character of applicants, company directors and key management personnel (the ‘fit and proper’ standard). This is not a vague concept; it is assessed against a series of specific criteria. First, applicants must disclose whether they have any criminal convictions, particularly for offences involving fraud, dishonesty or violence. Second, they must declare whether they have been convicted or received administrative penalties in Hong Kong or elsewhere for breaching laws relating to medicines, health products or trade. The authority will also consider whether they have been a director or senior officer of a company whose licence was revoked or whose application was refused, and whether they have been declared bankrupt or disqualified as a company director. The regulatory authority will verify these matters through background checks, criminal record checks and industry sources.