Q111 · Are there any specific qualification…

Q111 · Category C: Applicant eligibility and personnel requirements (Q101–Q150)

Yes, the qualifications for the Authorised Person (AP) of a proprietary Chinese medicine manufacturer are distinct from those for a western medicine manufacturer. Under the Chinese Medicine Council of Hong Kong (CMCC) guidelines, the qualifications for an AP of proprietary Chinese medicines are more flexible to reflect the characteristics of the Chinese medicine industry. The nominee will generally need one of the following backgrounds: 1) a registered Chinese medicine practitioner in Hong Kong; 2) a pharmacist who has taken courses related to Chinese medicines; 3) a degree in Chinese pharmacy, Chinese medicine, pharmacy or a related discipline; or 4) at least 10 years' extensive experience in the manufacture, quality control or research and development of proprietary Chinese medicines. Whatever their background, the AP must demonstrate to the Chinese Medicines Board that they have a thorough understanding of Good Manufacturing Practice (GMP) for proprietary Chinese medicines and can supervise the entire production process to ensure product safety, efficacy and consistent quality.

📘 Regulatory basis

The Chinese Medicine Ordinance (Cap. 549) and the subsidiary Guidelines on Good Manufacturing Practice for Proprietary Chinese Medicines set out the framework for the AP’s responsibilities and qualifications. In assessing an application, the Chinese Medicines Board will evaluate the nominee’s education, experience and professional knowledge as a whole.

📗 Drew Tang's recommendations

When looking for a suitable AP for a proprietary Chinese medicine manufacturer, the key is their depth of understanding of Chinese medicine. We recommend prioritising candidates with practical GMP management experience at a Chinese medicine manufacturer. In the application, highlight their knowledge and experience in identifying Chinese herbal medicines, processing techniques and quality standards (such as controlling heavy metals and pesticide residues).

📕 Risk notice

It is difficult to pass the Chinese Medicines Board’s review if an Western medicines expert with no knowledge of Chinese medicines is nominated as the AP. If the AP cannot identify genuine, authentic and good-quality Chinese herbal medicines, or does not understand the principles of traditional processing methods, they may be considered unsuitable for the role, causing delays to the application.

Plan Your Hong Kong Pharmaceutical Licensing Project with Drew Tang

Business Manager Tang Shangyong (Drew Tang) will review your products, operating model, licence type and preparation requirements with you one-to-one. The precise service scope is confirmed in writing; pharmaceutical duties are carried out by legally qualified personnel, and approvals are determined by the competent authorities.

Are there any specific qualification requirements for the “Authorised Person” (AP) when applying for a proprietary Chinese medicine manufacturer licence?

Plan Your Hong Kong Pharmaceutical Licensing Project with Drew Tang