Q354 · If we discover or receive a report of an…

Q354 · Category H: Licensed operations and routine regulatory oversight (Q351–Q400)

Monitoring and reporting adverse drug reactions (ADRs) is an important duty of licence holders in safeguarding public medicine safety. If, as a licensed wholesaler or manufacturer, you learn through any channel (such as healthcare professionals, patients or sales representatives) of information about a serious adverse reaction to a medicine you supply, you must initiate the reporting procedure. This generally involves: first, conducting an initial assessment immediately and collecting as much detail as possible, including information about the patient, medication history, and the nature and course of the adverse reaction. Next, completing the ADR report form provided by the Drug Office, Department of Health, under the Drug Safety Monitoring Programme. Finally, reporting it to the Department of Health within the prescribed time limit according to the seriousness of the reaction (unexpected and serious ADRs are generally required to be reported within 15 calendar days).

📘 Regulatory basis

Although Hong Kong law does not require all ADRs to be reported, the Codes of Practice for Pharmaceutical Wholesalers and Pharmaceutical Manufacturers both expressly state that licence holders are responsible for establishing a pharmacovigilance system and reporting serious or unexpected adverse reactions identified to the Department of Health.

📗 Drew Tang's recommendations

Establishing an internal pharmacovigilance Standard Operating Procedure (SOP) is essential. The SOP should identify the personnel responsible for handling ADR reports, information-collection templates, assessment criteria, and the specific procedures and timelines for reporting to the Drug Office, Department of Health. Regular training for sales and marketing staff on identifying and initially handling ADR information is key to ensuring it reaches the pharmacovigilance department promptly.

📕 Risk notice

Late, incomplete or concealed reporting of serious adverse drug reactions will not only damage the company’s reputation but may also pose a threat to public health. If the Department of Health learns of the matter through other channels and the licence holder has not reported it promptly, serious questions may be raised about the licence holder’s integrity and professional competence, potentially leading to further in-depth investigation and regulatory action.

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.

If we discover or receive a report of an adverse drug reaction, what reporting procedure should we follow?

Plan Your Hong Kong Pharmaceutical Licensing Project with Drew Tang