Introduction
China’s Investigational New Drug (IND) system and Europe’s Clinical Trial Application (CTA) framework represent two distinct yet increasingly aligned regulatory approaches. As biopharma innovation becomes more global, sponsors initiating multi-regional clinical trials must understand how these systems differ, and how effective coordination, supported by experienced CROs, can bridge regulatory expectations across regions.
1. Approval Process: Parallel vs. Coordinated Review
In China, IND submissions are overseen by the National Medical Products Administration (NMPA) and technically reviewed by the Center for Drug Evaluation (CDE). Once accepted, applications follow an implied approval mechanism, if no major objections are issued within 60 working days, the trial may proceed. Ethics reviews are conducted separately at each study site, emphasizing technical and safety assessment. Since September 2025, under the NMPA Announcement on Optimizing the Review and Approval of Clinical Trials for Innovative Drugs (No. 86 of 2025), eligible innovative drugs may apply for a 30-working-day accelerated review pathway, allowing parallel technical and ethics review to shorten timelines and enhance regulatory efficiency.
Ethics reviews are conducted independently by each clinical institution, focusing on technical feasibility and participant safety.
In European Union (EU)/European Economic Area (EEA), the CTA process under the EU Clinical Trials Regulation (EU CTR 536/2014) operates via the Clinical Trials Information System (CTIS). Applications undergo a two-part evaluation: Part I – Coordinated scientific assessment led by a Reporting Member State (RMS) on behalf of all participating countries; Part II – National ethics reviews addressing country-specific aspects (i.e. local patient safety, informed consent forms and overall compliance with national regulations). This integrated model enhances consistency and transparency across EU/EEA Member States but requires greater upfront coordination.
2. Documentation Standards: Alignment and Adaptation
Both systems require a protocol, investigator’s brochure, and investigational product documentation, though data standards differ. China’s CDE emphasizes detailed Chemistry-Manufacturing-Control (CMC) data and local preclinical evidence, while in Europe’s CTA dossier, the Investigational Medicinal Product Dossier (IMPD) is the key component with clinical, nonclinical and CMC information that aligns with ICH standards and EMA (European Medicines Agency) guidelines, emphasizing harmonization and risk-based documentation.
Early planning to align scientific content and jurisdiction-specific documentation can prevent redundant data collection and streamline review timelines.
3. Communication and Oversight
China’s IND process involves direct interactions between sponsors and CDE reviewers through written responses or technical meetings. In contrast, CTIS centralizes communication between sponsors and Member States in a single platform, enabling transparent tracking of queries and decisions.
While both systems are evolving toward greater transparency, the rhythm of communication differs, China allows focused bilateral exchanges, whereas the EU relies on coordinated, multi-stakeholder communication.
4. Bridging Through CRO Expertise
Global CROs play a vital role in bridging regulatory expectations between China and Europe. Teams experienced with both NMPA and EU CTR frameworks can map documentation equivalence and translation requirements, align submission timelines between CDE and CTIS, coordinate with ethics committees, and support risk-based quality management systems.
Integrating local regulatory insights with global standards helps sponsors streamline submissions and enhance compliance across regions.
Conclusion
China’s IND and Europe’s CTA share the same goals, ensuring participant safety and data integrity, yet differ in approval workflow and coordination mechanisms. Understanding these differences and leveraging cross-regional expertise enable sponsors to design efficient, compliant multi-regional development strategies.
References
- National Medical Products Administration (NMPA). Drug Registration Administration Measures (2020).
- National Medical Products Administration (NMPA). Announcement on Optimizing the Review and Approval of Clinical Trials for Innovative Drugs (No. 86 of 2025).
- European Medicines Agency (EMA). EU Clinical Trials Regulation (EU CTR 536/2014) and ICH E6(R3) GCP.
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