Overseas pharmaceutical companies planning clinical trials in China must submit an IND/CTA to the CDE (Center for Drug Evaluation, NMPA) before trial initiation. The application requires CTD-format dossiers and a qualified local agent in China.
BaiPharm provides end-to-end China IND/CTA submission support, including regulatory strategy, CTD dossier preparation (Module 1–5), pre-IND meeting coordination, clinical trial site support, and CDE communication management.
CTA: clinical trial application; IND: Investigational New Drug
Legal Basis
The following regulations govern clinical trial applications in China:
Drug Administration Law of the People's Republic of China (2019 Revision);
Regulations for the Implementation of the Drug Administration Law of the People's Republic of China (2026 Amendment);
Provisions of Drug Registration (2020 Revision);
NMPA Announcement No. 50 (2018) — Announcement on the Adjustment of Review and Approval Procedures for Clinical Trials of Drugs.
Registration Scope
This service covers clinical trial applications (CTA) within the territory of the People's Republic of China, encompassing both chemical drugs and biological products, including cell and gene therapy (CGT) products.
Eligibility of Applicants
An applicant shall be an enterprise or drug development institution capable of assuming corresponding legal responsibilities. Overseas applicants must entrust a China-based business entity as their local representative agent.
Application Procedure
Clinical trial applications for drug products in China follow a structured submission and review process managed by the Center for Drug Evaluation (CDE) under the National Medical Products Administration (NMPA).
Our Services
We provide comprehensive support throughout the entire IND/CTA lifecycle:
Application for Pre-IND meeting (CDE communication meeting) and preparation of relevant meeting materials;
Feasibility assessment and data gap analysis for the IND application (CTA) to identify potential deficiencies in the application dossier and minimize the risk of rejection;
Preparation of the IND application dossier checklist;
IND application dossier reviewing, translation, writing and submission based on ICH M4 format;
Editing and format conversion of application dossier;
All-the-way consulting service for IND application until review conclusion, including communications with CDE reviewers, response to CDE technical inquiries, preparation and submission of supplementary applications.
Why Choose BaiPharm?
BaiPharm, a specialized pharmaceutical regulatory subsidiary of REACH24H Consulting Group, operates globally with offices in the U.S., EU, Japan, and South Korea. Our team of regulatory specialists, GxP auditors, certified toxicologists, and former inspectors has supported over 600 pharmaceutical firms from 26 countries.
We have extensive hands-on experience in China IND/CTA applications, having successfully supported about hundreds of IND/CTA registration projects for international MNCs and leading domestic pharmaceutical companies across both chemical drugs and biologics, including significant experience with CGT products as an important and rapidly evolving segment of biologics.
Our expertise spans the entire IND/CTA lifecycle — from strategic dossier preparation through CDE communication and risk mitigation. Leveraging deep knowledge of NMPA regulations and review practices, we proactively identify potential deficiencies, minimize rejection or supplementation risk, and deliver end-to-end support for smooth regulatory approvals.
Related REACH24H Resources and Services
Explore more BaiPharm pharmaceutical regulatory services:
Product Registration
Pharmacovigilance (PV)
GxP Compliance
Regulatory Intelligence & Consulting
Toxicological Risk Assessment
Domestic Responsible Person (DRP)
Not sure where to start? Our regulatory experts are ready to help.
Email: customer@reach24h.com
