Overseas pharmaceutical companies seeking to market drugs in China must navigate the NMPA's registration framework — whether applying for a New Drug Application (NDA), Biologics License Application (BLA), or Abbreviated New Drug Application (ANDA) — and maintain compliance through post-marketing renewals.
BaiPharm provides end-to-end China drug registration support, including registration strategy analysis, CTD dossier preparation and submission, CDE communication management, clinical trial coordination, and post-marketing annual reports, variation, and renewal applications.
NDA: new drug application; BLA: biologics license application; ANDA: abbreviated new drug application
Legal Basis
The following regulations govern NDA, BLA, ANDA registrations and renewals 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).
NDA & BLA: Application for Marketing Authorization of New Drugs/Biologics
Product Scope
Marketing authorization approval of new drugs/biologics 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 agent.
Application Procedure
Application for marketing authorization of innovative new drugs and improved new drugs.
Clinical Trial & BE Study Application Preparation Process
NDA Marketing Authorization Review and Approval Timeline
Note: If applicable to expedited review and approval process, the review timeline will be shortened.
Our Services
Customized risk evaluation and optimized registration strategy analysis;
Feasibility assessment or data gap analysis for the NDA applications to avoid possible deficiencies in application dossier and to minimize the risk of rejection;
NDA application dossier review, translation, drafting and submission;
Support in sample testing and NMPA on-site inspection, on-site pre-audit or mock inspection (if necessary);
Navigate clinical trials study in all stages of development, design and implementation: provide experimental design and implementation planning, assistance for Clinical Research Organization (CRO) search in China, assessment and due diligence of CROs;
All-the-way consulting service for NDA application until review conclusion, including communications with CDE reviewers, reply to deficiency letter from CDE, preparation and submission of supplementary documents based on deficiency letter.
Why Choose BaiPharm?
BaiPharm, a specialized subsidiary of REACH24H Consulting Group, is dedicated to pharmaceutical regulatory compliance. With offices in the U.S., EU, Japan, and South Korea, our expert team — including regulatory specialists, GxP auditors, consultants, certified toxicologists, and former inspectors — has supported over 600 pharmaceutical firms from 26 countries.
With rich experience in China NDA/BLA/ANDA registration and registration renewal, we have successfully supported and provided regulatory consulting for well over 500 pharmaceutical registration and submission projects for international MNCs and leading domestic pharmaceutical companies.
We provide tailored registration strategy, full dossier compilation and submission, alongside one-stop support for CDE communication meeting, CRO selection, clinical/BE study arrangement and NMPA inspection coordination. Well-versed in NMPA regulations and review practices, we efficiently handle CDE deficiency responses, lower approval risks, and deliver full-process compliant registration services for innovative, biologic and generic drugs.
Related REACH24H Resources and Services
Explore more BaiPharm pharmaceutical regulatory services:
Not sure where to start? Our regulatory experts are ready to help.
Email: customer@reach24h.com
