INOPP Forum
Pharmacovigilance Requirements in Taiwan
Quote from VigiServe Admin on November 27, 2020, 2:11 PMTaiwan's pharmacovigilance (PV) system is mature and ICH-focused, with the Taiwan Food and Drug Administration (TFDA) leading ADR monitoring, signal detection, and VigiBase contributions as a WHO PIDM member since 1994. The framework under the Pharmaceutical Affairs Act emphasizes electronic reporting and post-marketing surveillance (PMS), with ICH full alignment targeted for 2026.
Legal Framework
Law: Governed by the Pharmaceutical Affairs Act and Regulations for Reporting Severe Adverse Reactions (updated effective Jan 1, 2025, refining timelines/content/investigations). Center for Drug Evaluation (CDE) aids assessments; PMS mandatory for new drugs (e.g., 5 years).
EU/ICH-aligned practice: Incorporates ICH E2 series; 2025–2026 updates include Q12, Q14, E6(R3); no formal EU GVP adoption.Organization and Personnel
Law: MAHs establish/maintain PV system; designate local PV responsible person/contact (typically Taiwan-based pharmacist/qualified professional) for TFDA liaison on safety/ADRs.
EU/ICH-aligned practice: No mandatory resident QPPV or PSMF, but detailed SOPs/documentation expected for inspections (PSMF-like structure common).Post-Marketing ICSRs
Law: MAHs report ADRs/errors/quality issues electronically; serious ADRs within 15 days (pharma companies); fatal/life-threatening serious: 15 days (with follow-up); non-serious voluntary/periodic.
EU/ICH-aligned practice: Aligns with ICH E2A (15-day serious unexpected); foreign relevant cases: 15 days; non-serious often 90 days or aggregates (practice, not strict law).Periodic Reports and RMPs
Law: PSUR/PBRER and RMP submissions per TFDA conditions (e.g., renewals); mandatory for new/high-risk products.
EU/ICH-aligned practice: ICH E2C(R2) format; initial 6-monthly (first 2 years), then annual (aligned with global schedules).Signal Management
Law: MAHs monitor/notify TFDA of signals/emerging issues promptly.
EU/ICH-aligned practice: TFDA uses VigiLyze/WHO tools (ICH-consistent).Clinical Trial Safety
Law: IND approval via TFDA (ICH GCP-aligned); sponsors report SUSARs/SAEs; fatal/life-threatening: 7 days (follow-up 8 days for institutions); other serious unexpected: 15 days. Annual safety reports required (DSUR-like, but no explicit DSUR mandate to TFDA).
EU/ICH-aligned practice: ICH E2A/E2F; GCP covers AE/SAE/SUSAR; ethics/IRB involvement.Additional Aspects
Law: HCP/patient reporting encouraged; risk-based inspections; retain records 5+ years.
EU/ICH-aligned practice: No black triangle, but enhanced monitoring for new/biologics; electronic focus (E2B(R3) promoted).
Taiwan's system is ICH-oriented with strong enforcement; consult fda.gov.tw for updates (e.g., 2025 ADR rules).
Taiwan's pharmacovigilance (PV) system is mature and ICH-focused, with the Taiwan Food and Drug Administration (TFDA) leading ADR monitoring, signal detection, and VigiBase contributions as a WHO PIDM member since 1994. The framework under the Pharmaceutical Affairs Act emphasizes electronic reporting and post-marketing surveillance (PMS), with ICH full alignment targeted for 2026.
Legal Framework
Law: Governed by the Pharmaceutical Affairs Act and Regulations for Reporting Severe Adverse Reactions (updated effective Jan 1, 2025, refining timelines/content/investigations). Center for Drug Evaluation (CDE) aids assessments; PMS mandatory for new drugs (e.g., 5 years).
EU/ICH-aligned practice: Incorporates ICH E2 series; 2025–2026 updates include Q12, Q14, E6(R3); no formal EU GVP adoption.
Organization and Personnel
Law: MAHs establish/maintain PV system; designate local PV responsible person/contact (typically Taiwan-based pharmacist/qualified professional) for TFDA liaison on safety/ADRs.
EU/ICH-aligned practice: No mandatory resident QPPV or PSMF, but detailed SOPs/documentation expected for inspections (PSMF-like structure common).
Post-Marketing ICSRs
Law: MAHs report ADRs/errors/quality issues electronically; serious ADRs within 15 days (pharma companies); fatal/life-threatening serious: 15 days (with follow-up); non-serious voluntary/periodic.
EU/ICH-aligned practice: Aligns with ICH E2A (15-day serious unexpected); foreign relevant cases: 15 days; non-serious often 90 days or aggregates (practice, not strict law).
Periodic Reports and RMPs
Law: PSUR/PBRER and RMP submissions per TFDA conditions (e.g., renewals); mandatory for new/high-risk products.
EU/ICH-aligned practice: ICH E2C(R2) format; initial 6-monthly (first 2 years), then annual (aligned with global schedules).
Signal Management
Law: MAHs monitor/notify TFDA of signals/emerging issues promptly.
EU/ICH-aligned practice: TFDA uses VigiLyze/WHO tools (ICH-consistent).
Clinical Trial Safety
Law: IND approval via TFDA (ICH GCP-aligned); sponsors report SUSARs/SAEs; fatal/life-threatening: 7 days (follow-up 8 days for institutions); other serious unexpected: 15 days. Annual safety reports required (DSUR-like, but no explicit DSUR mandate to TFDA).
EU/ICH-aligned practice: ICH E2A/E2F; GCP covers AE/SAE/SUSAR; ethics/IRB involvement.
Additional Aspects
Law: HCP/patient reporting encouraged; risk-based inspections; retain records 5+ years.
EU/ICH-aligned practice: No black triangle, but enhanced monitoring for new/biologics; electronic focus (E2B(R3) promoted).
Taiwan's system is ICH-oriented with strong enforcement; consult fda.gov.tw for updates (e.g., 2025 ADR rules).