Overseas manufacturers of generic drugs seeking market entry in China must submit an Abbreviated New Drug Application (ANDA) to demonstrate bioequivalence to a reference listed drug and meet NMPA requirements for safety, efficacy, and quality.
BaiPharm provides comprehensive China ANDA registration support, including local agent authorization, dossier preparation and translation, CDE communication, bioequivalence (BE) study coordination, sample testing, and NMPA inspection support.
Product Scope
ANDA covers generic drugs which are imported, sold, and used within the territory of the People's Republic of China.
Eligibility of Applicants
Domestic applicants shall be an enterprise or drug development institution that can assume corresponding legal responsibilities.
For overseas-manufactured generic drugs, overseas applicants shall be able to provide a certificate issued by the relevant overseas drug regulatory authority demonstrating that the product has been approved for marketing, and they must entrust a China business entity as their local agent.
Application Procedure
Domestic generic drugs, imported generic drugs.
Our Services
Authorization to act as local agent for drug registration;
Support for application materials checklist and data gap analysis for feasibility assessment;
Customized risk evaluation and optimized registration strategy analysis to avoid possible deficiencies in application dossier and to minimize the risk of rejection;
ANDA application dossier review, translation, drafting and submission;
Support in communications with CDE reviewers;
Support in sample testing and NMPA on-site inspection, on-site pre-audit or mock inspection (if necessary);
Navigate clinical trials or bioequivalence (BE) 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 services for drug registration until review conclusion, including communications with CDE reviewers, reply to deficiency letters from CDE, preparation and submission of supplementary applications.
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:
NDA/BLA/ANDA Registration & Renewal
Clinical Trial Applications (IND/CTA)
Post-Marketing Compliance
GxP Compliance
Domestic Responsible Person (DRP)
Toxicological Risk Assessment
Not sure where to start? Our regulatory experts are ready to help.
Email: customer@reach24h.com
