Your Trusted Local Pharmacovigilance Partner in Taiwan
At DDReg, we deliver operationally rigorous, inspection ready Pharmacovigilance Services in Taiwan tailored for Marketing Authorisation Holders (MAHs), pharmaceutical and biotech companies, and global sponsors seeking real world drug safety performance. With our unique blend of global pharmacovigilance expertise and local regulatory insight, we ensure your safety systems, reporting workflows, and compliance practices succeed under Taiwan’s regulatory expectations.
Pharmacovigilance and Drug Safety Obligations in Taiwan
In Taiwan, pharmacovigilance and post market safety surveillance fall under the authority of the Taiwan Food and Drug Administration (TFDA) within the Ministry of Health and Welfare. The TFDA’s regulatory framework requires companies marketing pharmaceuticals and biologics in Taiwan to actively monitor, assess, and report safety data, including adverse reactions and emerging product risks. National rules mandate timely reporting of serious adverse drug reactions and ongoing safety monitoring as part of structured lifecycle compliance.
- Establishing a responsible pharmacovigilance contact or local safety officer within Taiwan aligned with regulatory expectations.
- Implementing systems capable of collecting, assessing, and submitting adverse event information to TFDA in required timeframes.
- Managing post market surveillance workflows that can withstand inspection scrutiny and provide traceability across case handling, risk assessment, and safety communication.
TFDA updates effective January 1, 2025 further refine severe adverse reaction reporting requirements, adding specifications for reporting content, timelines, and investigational responses.
QPPV / Responsible Pharmacovigilance Person Requirements in Taiwan
While Taiwan does not mandate an EU style Qualified Person for Pharmacovigilance (QPPV) in name, TFDA does require that MAHs designate a local pharmacovigilance responsible person or contact. This individual, often a pharmacist or qualified healthcare professional based in Taiwan, acts as the official point of contact for TFDA regarding safety data, adverse event reports, and risk communications.
- Adverse Event Reporting: Ensuring adverse events, especially serious or unexpected reactions, are reported to TFDA within mandatory timelines and in the prescribed formats.
- Regulatory Communication: Serving as a direct liaison with TFDA on safety issues, inspections, and queries.
- Accountability: Maintaining accountability for the pharmacovigilance system’s performance in Taiwan and its adherence to local norms.
DDReg’s Local Contact Person for Pharmacovigilance Taiwan services provide experienced professionals who fulfill these expectations, directly integrated with your global PV governance model.
Taiwan’s pharmacovigilance framework is grounded in both local legislation and internationally recognised standards:
- Pharmaceutical Affairs Act: Core legislation governing drug licensing, post market surveillance, and safety obligations in Taiwan.
- Regulations for Reporting Severe Adverse Reactions of Medicaments: Updated rules defining mandatory adverse reaction reporting requirements and timelines.
- Good Pharmacovigilance Practices: Local PFvP guidelines adapted to Taiwan’s regulatory expectations.
- International Standards (ICH, WHO): TFDA’s PV model aligns with ICH safety reporting conventions and broader WHO pharmacovigilance frameworks, ensuring harmonisation with global PV norms.
These references form the backbone of compliant TFDA pharmacovigilance services and safety lifecycle management in Taiwan.
Our Pharmacovigilance & Drug Safety Services in Taiwan
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Individual Case Safety Report (ICSR) Management
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Aggregate Safety & Periodic Reporting
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Signal Detection & Risk Management
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PV System Setup, Maintenance & Audit Support
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QPPV and Local Pharmacovigilance Support
Why Choose DDReg
Choosing DDReg means partnering with a Pharmacovigilance Service Provider Taiwan that combines:
- Global pharmacovigilance expertise with deep understanding of TFDA expectations
- Operational reliability that supports inspection readiness
- Scalable delivery models tailored to your product portfolio
- Proactive risk monitoring and compliance assurance
- Localised insights including Taiwan local literature screening and monitoring
We enable you to navigate Taiwan’s safety landscape with confidence and control.
Our Pharmacovigilance (PV) Services Expertise
ICSR Case Processing and Submission
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Literature Monitoring
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Risk Management
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Audit and Compliance
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Pharmacovigilance Signal Management Services
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QPPV Services
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