Your Local Pharmacovigilance Partner for Drug Safety in Hong Kong
If you are a pharmaceutical company, biotechnology firm, or Marketing Authorisation Holder operating in Hong Kong, having a compliant and inspection-ready pharmacovigilance setup is critical. Hong Kong’s post-marketing safety expectations place direct accountability on product sponsors to monitor, report, and manage drug safety risks effectively.
At DDReg, we provide specialised Pharmacovigilance Services in Hong Kong, combining global pharmacovigilance governance with local regulatory execution. From drug safety services Hong Kong to strategic PV outsourcing, DDReg supports companies across the entire product lifecycle with reliable, audit-defensible pharmacovigilance operations.
Understanding Pharmacovigilance in Hong Kong
Pharmacovigilance activities in Hong Kong are overseen by the Drug Office, Department of Health, which operates the local adverse drug reaction (ADR) reporting framework. Marketing Authorisation Holders, local distributors, and licence holders are expected to establish internal pharmacovigilance systems capable of identifying, evaluating, and reporting safety information throughout a product’s market presence.
Hong Kong follows internationally aligned pharmacovigilance principles, with expectations closely linked to ICH guidelines and WHO pharmacovigilance practices. Companies are required to ensure timely ADR reporting, maintain safety documentation, and respond effectively to regulatory safety queries.
QPPV / Pharmacovigilance Responsible Person Expectations in Hong Kong
Hong Kong does not mandate an EU-style Qualified Person for Pharmacovigilance (QPPV) by title. However, regulators expect companies to designate a responsible pharmacovigilance contact who ensures continuous safety oversight and regulatory communication.
In practice, many global companies appoint a QPPV-equivalent or senior pharmacovigilance lead to manage Hong Kong safety obligations within their global PV framework.
- A designated pharmacovigilance contact responsible for Hong Kong safety activities
- Oversight of adverse event collection, evaluation, and reporting
- Maintenance of pharmacovigilance procedures and documentation
- Timely communication with the Hong Kong Department of Health on safety matters
- Alignment of local safety activities with global PV governance
DDReg supports these requirements through QPPV Services in Hong Kong, providing experienced safety leadership and regulatory oversight.
Key Regulatory References Governing Pharmacovigilance in Hong Kong
-
Department of Health – Drug Office Pharmacovigilance Guidelines
Defines post-marketing safety reporting expectations, ADR submission pathways, and stakeholder responsibilities.
-
ICH Safety Guidelines (E2 Series)
Adopted as reference standards for safety data management, signal detection, and aggregate reporting.
-
WHO Pharmacovigilance Frameworks
Inform Hong Kong’s ADR monitoring and international safety data exchange practices.
These frameworks ensure Hong Kong’s pharmacovigilance system remains globally harmonised while maintaining local patient safety oversight.
Our Pharmacovigilance & Drug Safety Services in Hong Kong
-
Individual Case Safety Report (ICSR) Management
-
Aggregate Safety & Periodic Reporting
-
Signal Detection & Risk Management
-
PV System Setup, Maintenance & Audit Support
-
QPPV and Local Pharmacovigilance Support
-
Local Literature Monitoring & Surveillance
Why Choose DDReg as Your Pharmacovigilance Company in Hong Kong?
As a global regulatory science and drug-safety firm, DDReg acts as a trusted local pharmacovigilance partner in Hong Kong, delivering operational depth and regulatory reliability. Our teams understand how Hong Kong safety expectations intersect with global pharmacovigilance systems reducing compliance risk and operational friction.
Through our pharmacovigilance consulting Hong Kong and pharmacovigilance outsourcing in Hong Kong offerings, DDReg supports companies seeking long-term regulatory sustainability, inspection readiness, and scalable drug safety operations.
Our Pharmacovigilance (PV) Services Expertise
ICSR Case Processing and Submission
Our advanced Individual Case Safety Report (ICSR) Pharmacovigilance Services are dedicated to ensuring patient safety through precise case handling....
Literature Monitoring
DDReg’s Literature Monitoring Services offer advanced pharmacovigilance literature screening for drug safety. We help Marketing...
Risk Management
Our expert risk management solutions ensure patient safety by proactively addressing potential hazards in pharmaceutical...
Audit and Compliance
Our specialized services ensure that pharmacovigilance systems across the drug development pipeline meet strict regulatory...
Pharmacovigilance Signal Management Services
DDReg’s specialized pharmacovigilance services ensure that potential adverse events are identified and addressed promptly...
QPPV Services
DDReg’s expert team provides comprehensive QPPV services designed to strengthen your pharmacovigilance system. We ensure that...
