PSUR Central – Global PSUR & PBRER Services
Strategic Compliance for Taiwan’s Biomedical Hub: TFDA | CDE | ICH | GVP
PSUR Central, the specialized scientific arm of Zoesoe Exports Pvt Ltd, provides premium Periodic Safety Update Report (PSUR) and PBRER services tailored for Taiwan’s innovative pharmaceutical sector—from the biotech clusters of Nangang and Hsinchu to the established manufacturers in Taoyuan.
Taiwan is rapidly emerging as the "TSMC of Biotech," with the government’s "5+2 Innovative Industries Plan" driving an output goal of NT$1 trillion by 2025. As of August 2025, the regulatory landscape has been bolstered by the Regenerative Medicinal Products Act, which mandates ultra-frequent safety reporting for advanced therapies. Whether you are navigating New Drug Applications (NDA) or managing post-market surveillance for generics, our dossiers are designed to satisfy the rigorous scientific scrutiny of the TFDA and the Center for Drug Evaluation (CDE).
Who We Support in Taiwan
We provide specialized pharmacovigilance expertise across Taiwan’s high-tech life sciences ecosystem:
Innovative Biotech Firms: Drafting complex PBRERs for cell and gene therapies under the 2025 Regenerative Medicine dual-track framework.
Global CDMOs & Biologics Leaders: Supporting Taiwan’s "Pharma 4.0" manufacturing sites with global aggregate safety data integration.
Taiwanese Marketing Authorization Holders (MAHs): Assisting local firms in meeting the mandatory 5-year monitoring period for new drugs, including active worldwide safety data collection.
Local Pharmaceutical Agents: Providing the technical scientific bandwidth required by Taiwan-based representatives to manage TFDA e-platform submissions and authority queries.
Clinical Trial Sponsors: Managing Development Safety Update Reports (DSURs) for multi-regional clinical trials (MRCTs) leveraging Taiwan’s simplified First-In-Human (FIH) approval process.
Our PSUR & PBRER Services
Our scientific precision aligns with Taiwan’s commitment to international harmonization and patient safety:
Regenerative Medicine Specialized Reporting: Expert drafting of PSURs required every six months for the first two years for regenerative products, as per the August 2025 Safety Monitoring Measures.
ICH E2C (R2) Compliant PBRERs: Comprehensive benefit-risk evaluations that align with Taiwan’s membership in the ICH and satisfy CDE clinical reviewers.
Local Signal Detection: Utilizing scientific methodologies to validate and assess safety signals, incorporating data from the National Research Program for Biopharmaceuticals and local ADR reports.
E-Submission Excellence: Ensuring all dossiers are formatted for seamless upload via the TFDA E-Platform for Review & Submission, active since 2018 and upgraded for 2025.
Bridging Study Evaluation (BSE) Support: Aligning safety data in PBRERs to support ethnic sensitivity analyses, a critical requirement for the Taiwanese population.
Why Pharma Leaders in Taiwan Choose PSUR Central
"Scientific rigor for one of Asia's most advanced and innovation-friendly regulatory environments."
2025 Regulatory Specialists: Fully versed in the June 2024 Regenerative Medicine Acts and their 2025 implementation measures, ensuring your high-tech therapies remain compliant.
CDE Review Readiness: We understand the technical nuances of Taiwan CDE reviews, providing reports that proactively address potential "External Expert" queries to keep your timelines on track.
Language & Technical Precision: While the TFDA accepts English dossiers, we ensure all summary safety information is optimized for the mandatory Traditional Chinese labeling and instructions for use.
Audit-Ready Quality: Our reports have a 100% acceptance track record with the TFDA, PMDA (Japan), US FDA, and EMA.
Regulatory Standards Followed
Our documentation is meticulously prepared in alignment with:
Pharmaceutical Affairs Act (Article 45-1): The legal foundation for ADR reporting and safety monitoring in Taiwan.
Regenerative Medicinal Products Act (2024/2025): The new standard for advanced therapy safety surveillance.
Regulations for Management of Medical Device Safety Surveillance: Updated in 2025 for high-risk and innovative devices.
ICH E2C (R2): The global benchmark for periodic benefit-risk reporting.
Get Started: Partner With Us
To initiate a customized project for your Taiwan-based operations, we typically require:
Product Portfolio and registration type (NDA, ANDA, or Regenerative Medicine).
Monitoring Status: Details on whether the product is within its 5-year (drugs) or 3-year (devices) active monitoring period.
Approved Labeling: The Traditional Chinese SmPC/Package Insert and Reference Safety Information (RSI).
Local ADR Data: Summary of serious adverse drug reactions reported to the Taiwan National ADR Center.
Submission Timeline: Coordination with TFDA e-submission windows and CDE review cycles.
Contact PSUR Central today to ensure your pharmaceutical safety compliance in Taiwan is authority-ready and scientifically robust.
Global PSUR Compliance. Science-Driven. Authority-Ready.