Quote from VigiServe Admin on November 27, 2020, 12:56 PM

 

ONLINE AE FORM

The pharmacovigilance (PV) system in **Hong Kong** is established and operates under the **Department of Health (DH)** through the **Drug Office** (Drug Evaluation and Pharmacovigilance Division), which serves as the national regulatory authority for medicines. Hong Kong is a full member of the WHO Programme for International Drug Monitoring (PIDM), contributing to VigiBase. The system focuses primarily on voluntary spontaneous reporting of adverse drug reactions (ADRs) for post-marketing surveillance, with a risk-based approach to monitoring safety, efficacy, and quality of registered pharmaceutical products. There is no comprehensive standalone national Good Pharmacovigilance Practices (GVP) guide equivalent to EU modules; instead, requirements are outlined in specific guidance documents from the Drug Office.

**Legal Framework and Governance**
- Governed by the **Pharmacy and Poisons Ordinance** (Cap. 138) and related regulations.
- The **Drug Office** (part of DH) handles ADR collection, causality assessment, risk evaluation, market surveillance, investigations, and regulatory actions (e.g., alerts, recalls).
- Key documents:
- **Guidance for Pharmaceutical Industry – Adverse Drug Reaction Reporting Requirements** (applies to industry/MAHs/registration holders).
- **Guidance for Healthcare Professionals – Adverse Drug Reaction Reporting**.
- Reporting is largely voluntary for healthcare professionals (HCPs) but expected/required for industry in certain cases (e.g., serious local events).

**Organization and Personnel**
- Marketing Authorization Holders (MAHs)/registration certificate holders must monitor product safety proactively and report relevant information to the Drug Office.
- No strict mandatory appointment of a local **Qualified Person for Pharmacovigilance (QPPV)** or resident PV contact is detailed in public guidelines (though a designated PV contact/responsible person is often expected in practice for compliance).
- No formal **PV System Master File (PSMF)** or registration/location requirement is specified.

**Individual Case Safety Reports (ICSRs) – Post-Marketing**
- HCPs (doctors, dentists, pharmacists, nurses, Chinese medicine practitioners) are encouraged to report suspected ADRs voluntarily to the Drug Office (via online form, email, fax, post, or paper).
- MAHs/registration holders must report serious ADRs occurring in Hong Kong (and monitor significant changes affecting safety/quality/efficacy).
- Timelines (per industry guidance):
- **Serious ADRs** (local/domestic): Report **as soon as possible** (expedited emphasis; some sources indicate prompt/urgent for serious unexpected).
- **Non-serious ADRs**: Periodic or as part of aggregates/on request.
- Foreign ADRs: Typically not expedited; included in updates if relevant.
- Additional: Immediate/within 72 hours for certain major foreign regulatory actions (e.g., restrictions, bans) impacting safety.

**Periodic Benefit-Risk Evaluation Reports (PBRER/PSUR)**
- No routine mandatory periodic submissions (e.g., no standard 6-monthly/annual cycle) are explicitly detailed in public guidelines for all products.
- Safety updates may be required during registration renewals, variations, or on request by the Drug Office (aligned with basic WHO/international formats).

**Risk Management Plans (RMP)**
- Not a standard mandatory requirement for all products. Risk assessment occurs reactively through ADR analysis and Drug Office evaluation.

**Signal Management and Emerging Safety Issues**
- Drug Office conducts ongoing surveillance and risk assessment of ADR reports.
- MAHs monitor data and notify significant/emerging issues (e.g., new risks, foreign actions) promptly (no fixed timelines like 5–45 days publicly specified beyond general promptness).

**Clinical Trials-Related Safety Requirements**
Clinical trials require Drug Office approval (via Clinical Trial Certificate/Medicinal Test application and ethics review).
- Sponsors/Certificate Holders must monitor safety and report drug-related safety information.
- **Suspected Unexpected Serious Adverse Reactions (SUSARs)/serious events**: Expedited reporting required (aligned with international norms; typically **7–15 days** for serious unexpected, faster for fatal/life-threatening, though exact timelines are per approval/guidance rather than rigidly codified).
- All local drug-related safety reports (including SAEs) submitted to the Clinical Trials and Pharmacovigilance Unit (email: ct@dh.gov.hk).
- Periodic reporting: Annual/Development Safety Update Reports (DSURs) or progress reports may be required/requested (ICH E2F or WHO formats), especially for ongoing trials.
- Sponsor responsibility for monitoring, causality assessment, and communication to Drug Office/ethics bodies.

**Additional Monitoring / Other Aspects**
- No black triangle/additional monitoring scheme.
- Emphasis on voluntary HCP reporting, industry obligations for serious local events, quality surveillance (sampling/testing), counterfeit detection, and public health integration.
- Reporting volumes are supported by online tools and awareness efforts; low under-reporting addressed via guidance.

Hong Kong's PV framework is functional and WHO-aligned but relatively basic and voluntary-focused — no stringent MAH obligations like routine PSUR cycles, mandatory local QPPV/PSMF/RMP for all, or highly detailed expedited timelines compared to ICH/EU-harmonized systems (e.g., Turkey, Malaysia). It prioritizes spontaneous reporting and regulatory assessment over complex industry bureaucracy.

For precise, product- or trial-specific requirements (e.g., current forms, exact timelines in latest industry guidance, or clinical trial submissions), consult the **Drug Office, Department of Health** directly via drugoffice.gov.hk (ADR Reporting/Pharmaceutical Trade sections, guidelines downloads, or Clinical Trials and Pharmacovigilance Unit contacts at ct@dh.gov.hk or 2319 2920), as documents/guidance may be updated (e.g., revisions noted in 2024–2025). Companies often align with WHO minimums or reference international standards for operations in Hong Kong.