Will the regulatory authorities review my business plan during the approval process?

The official requirements for a pharmaceutical licence application in Hong Kong do not make it mandatory for applicants to submit a detailed business plan. The regulatory authorities’ main concern is whether you meet the statutory compliance requirements for premises, personnel and the QMS. They are more concerned with “how you will operate compliantly” than with “how you will make a profit”. This does not mean, however, that a business plan is of no use. Although it is not required, a professional and rigorous business plan can be a very persuasive supporting document. It can help reviewing officers better understand your business model, company background, management team’s expertise and commitment to long-term compliant operations. In some borderline cases—for example, where the Responsible Person (RP) has an unconventional background—a business plan setting out a clear development roadmap and sound financial projections may provide useful support.