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3 min read
Introduction
Pharmacovigilance Hong Kong is gaining importance as pharmaceutical companies aim to ensure drug safety and compliance throughout the entire product lifecycle.
Pharmacovigilance (PV), the science and activities relating to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problems, plays a critical role throughout the entire product lifecycle. In Hong Kong, this becomes particularly important given the evolving regulatory framework governed by the Drug Office of the Department of Health.
Whether a company is seeking market entry, expanding indications, or managing post-market commitments, pharmacovigilance must be seamlessly integrated with product lifecycle management to ensure ongoing safety and regulatory compliance.
Pharmacovigilance Hong Kong: Regulatory Landscape
“Guidance for Pharmaceutical Industry – Adverse Drug Reaction Reporting Requirements” shall be followed by registration certificate holder in Hong Kong. Risk Management and Operations and Drug Evaluation and Pharmacovigilance are two divisions of Drug Office who are responsible for the market surveillance, carry out investigation and carry out the risk assessment as regards to the ADR (Adverse Drug Reaction) reports.
In addition, the Department of Health has put in place a pharmacovigilance system to monitor the safety of registered pharmaceutical products supplied in Hong Kong. The pharmacovigilance system includes an adverse drug reaction (ADR) reporting platform, which also receives adverse events following immunization (AEFIs) reports related to vaccination
Marketing Authorization Holders (MAHs) are required to:
- Monitor any significant changes or any conditions relating to the manufacturer or to the manufacture of a pharmaceutical product which may affect product safety, quality or efficacy of the registered drug proactively and report to Drug Officer.
- Report to Drug Office no later than 72 hours after receipt of information regarding any actions taken by overseas drug regulatory authorities on the registered drug as a consequence of any safety concern of drug product.
- Report all serious adverse drug reactions of the registered drug occurring in Hong Kong to Drug Office
- Document any defect impacting the quality of the registered drug release for sale or distribution
Pharmacovigilance Across the Product Lifecycle
1. Pre-Approval Phase
- Activities: Risk analysis, benefit-risk assessment, protocol design for clinical trials.
- Goal: Anticipate and prepare for potential safety issues.
- PV Responsibilities: Safety data collection and reporting during local clinical trials (if applicable).
2. Regulatory Submission Phase
- Activities: Preparation of risk management plan (RMP), inclusion of safety data in the dossier.
- Goal: Convince the Drug Office that benefits outweigh risks.
- PV Responsibilities: Submission of PV plans and evidence of a pharmacovigilance system (if requested).
3. Approval and Launch
- Activities: Local safety officer appointment, system setup for ADR collection.
- Goal: Safe introduction to market.
- PV Responsibilities: Maintain SOPs for ADR reporting in Hong Kong and ensure compliance readiness.
4. Post-Marketing Surveillance
- Activities: ADR monitoring, literature review, safety signal detection.
- Goal: Maintain favorable risk-benefit ratio.
- PV Responsibilities: Ongoing spontaneous reporting, periodic safety reports (e.g., PSUR/PBRER), and local case management when required.
5. Lifecycle Changes (e.g., New Indications, New Formulations)
- Activities: Updating safety documents, reassessing benefit-risk.
- Goal: Align PV system with the updated product profile.
- PV Responsibilities: Evaluate new data, update risk management tools, communicate with regulators.
6. Product Withdrawal or Suspension
- Activities: Final risk assessment, regulator communication.
- Goal: Ensure responsible discontinuation.
- PV Responsibilities: Submit final safety reports and manage any remaining safety obligations.
Summary
| Lifecycle Stage | Key PV Activities | Regulatory Considerations in Hong Kong |
| Pre-Approval | Risk identification, trial safety monitoring | Local clinical trial ADR reporting (if applicable) |
| Regulatory Submission | RMP development, safety data compilation | Provide safety justifications, PV system description (if asked) |
| Product Launch | PV system setup, local safety officer designation | Ensure SOPs and reporting timelines meet Drug Office standards |
| Post-Marketing | Spontaneous ADRs, signal detection, PSUR submission (if required) | Submit PSURs, manage drug safety Hong Kong obligations |
| Lifecycle Changes | Update risk-benefit profiles, evaluate new data | Communicate safety updates with Drug Office |
| Product Withdrawal | Safety reassessment, final PV documentation | Notify and justify to regulators with final PV report |
Final Thoughts
Pharmacovigilance is not just about compliance—it is a strategic tool that enhances drug safety in Hong Kong and builds trust with regulators and patients. Effective PV systems integrated throughout the lifecycle can safeguard public health while supporting sustainable market access.
For companies, engaging a local safety expert or experienced partner familiar with the Drug Office pharmacovigilance requirements ensures seamless compliance and long-term success.
Contact Freyr today
