Clinical Trial Application, Bioequivalence Study, and Multi-Regional Clinical Trials in China

CTA: clinical trial application; BE study: bioequivalence (BE) Study; MRCTS: multi-regional clinical trials

Legal Basis

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 (2019 Amendment);
Measures for the Administration of Drug Registration (2020 Revision);
Announcement No. 50 of NMPA, 2018, Announcement on the Adjustment of Review and Approval Procedures for Clinical Trials of Drugs.

Registration Scope

Clinical trial application (CTA) for drug market approval within the territory of the People’s Republic of China.

Eligibility of Applicants

An applicant shall be an enterprise or drug development institution that can assume corresponding legal responsibilities. Overseas applicants must entrust a China business entity as their local agency.

Application Procedure

Clinical trial application (CTA) of innovative new drugs and improved new drugs

Our Services

Application for Pre-IND meeting and preparation of relevant meeting materials;
Feasibility assessment/data gap analysis for the IND application to avoid possible deficiencies in the application dossier and to minimize the risk of rejection;
Preparation of the outline of the IND application dossier;
IND application dossier reviewing work, translation, writing and submission in CTD format;
e-CTD document editing and format conversion;
Testing sample, testing application, progress tracking and support;
All-the-way consulting service for IND application until approval, including communications with CDE reviewers, reply to deficiency letters from CDE, preparation and submission of supplementary applications.

Why Choose BaiPharm

Our experts have achieved a thorough professional understanding of pharmaceutical regulations and extensive experience to provide solutions across all critical stages in the drug life cycle. We’re committed to providing clients with professional and customizable pharmaceutical regulatory compliance services, including market entry consultation and registration of prescription drugs, OTCs, APIs, excipients and packaging materials. Our constant driver is to ensure high-level professional and efficient solutions for outstanding pharmaceutical enterprises across the globe.