• Systematically compile, organize, convert and submit registration documents in compliance with registration requirements;

• Conduct gap analysis and compliance review of registration dossiers;

• Monitor official review progress throughout the process, promptly respond to deficiency letters and complete technical revisions;

• Handle clinical trial applications, BE study registration, and official meeting coordination (if applicable);

• Provide end-to-end follow-up for sample registration testing;

• Offer full-process support for registration on-site inspections/GMP audits;

• Maintain registration dossier updates and prepare/submit annual reports.

1. Definition and Background

Domestic drug product marketing authorization application refers to the submission of applications to the National Medical Products Administration (NMPA) for drug products (e.g., tablets, capsules, injections) manufactured in China after completing non-clinical studies (if applicable), clinical trials (if applicable), and production validation.

Under the Drug Administration Law of the People's Republic of China and the Drug Registration Regulation, drug marketing requires strict technical review and administrative approval to ensure safety, efficacy, and quality control. Manufacturers must provide complete research data and production information, reference registered APIs, excipients, and packaging materials, and obtain the Drug Registration Certificate before marketing.

2. Applicable Scope

Drug Types: Chemical drugs (innovative drugs, generics), biological products (including biosimilars).

Application Categories:

New drug application: First-time marketing of innovative or improved drugs in China.

Generic drug application: Generics with equivalent quality and efficacy to reference listed drugs.

Supplemental application: Post-approval changes (e.g., process variations, new indications, specification changes).

3. Basic Requirements

CTD-format Dossier:

Module 1: Application forms, product information, application status.

Module 2: Quality overall summaries (2.3.S/2.3.P), non-clinical/clinical overviews.

Module 3: Body of data (3.2.S/3.2.P), including process validation, stability studies.

Module 4: Non-clinical study reports.

Module 5: Clinical study reports.

4. Application Process

1）Document Preparation: Compile pharmaceutical, non-clinical, and clinical data per Requirements for Chemical Drug Registration Classification and Dossier Submission.

2）Application Submission: Submit forms and self-checklists via NMPA’s portal.

3）Formal Review: CDE assesses dossier completeness.

4）CFDI Registration Inspection/NIFDC Testing.

5）Technical Review:

Standard: ~200 working days

Priority review: ~130 working days

Urgent rare disease review: 70 working days

6）Approval & Certification: NMPA issues Drug Registration Certificate if approved.

5. Regulatory Basis

Drug Administration Law of the People's Republic of China

Drug Registration Regulation

Requirements for Chemical Drug Registration Classification and Dossier Submission

Good Manufacturing Practice for Drugs

Note: Primarily describes chemical drug registration via CDE.