• Provide registration agency services for overseas drug registration applications;

• Pre-registration compliance consultation: Including but not limited to feasibility assessment of bridging foreign clinical data to domestic requirements and development of differentiated submission strategies;

• Professional translation and proofreading of foreign-language registration documents;

• Systematically compile, organize, convert formats, and submit registration dossiers in compliance with regulations;

• 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

Definition:

Import registration of chemical generic drugs refers to the statutory process where overseas-manufactured chemical drugs identical to the Reference Listed Drug (RLD) in active ingredients, dosage form, strength, quality, and efficacy must submit applications to China's National Medical Products Administration (NMPA), undergo technical review, and obtain the Drug Registration Certificate before entering the Chinese market.

Background:

Drugs are special commodities directly impacting public health. Overseas drugs must pass regulatory review to ensure quality and efficacy before sale in China. This system prevents substandard drugs from entering the market and mitigates risks of counterfeit/inferior drugs.

2. Applicable Scope

Target Applicants:

·Overseas-manufactured chemical generics (e.g., tablets, capsules, injections) with RLDs approved in China or ICH regions (e.g., US, EU, Japan).

·Imported generics for repackaging (must submit repackaging process validation and quality comparison data vs. RLD).

Scenarios:

·First-time import to China;

·Major changes to registered imported generics (e.g., formulation/process adjustments, new strengths);

·Re-registration before expiry (5-year validity).

Exclusions:

·Generics without overseas approval or clear RLDs;

·Imported samples for R&D only (require Import Drug License).

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

Core Laws & Standards:

·Laws:

Drug Administration Law of the People's Republic of China (2021 revision)

Drug Registration Regulation (NMPA Order No. 27)

·Departmental Rules:

Catalog of Reference Listed Drugs for Chemical Generics (NMPA updates)

Requirements for New Chemical Drug Classification and Dossier Submission (Announcement 2020 No. 44)

·Guidelines:

Technical Guidelines for Bioequivalence Studies of Chemical Generics

Dossier Requirements for Quality and Efficacy Consistency Evaluation of Oral Solid Generics

ICH Q1A (stability), Q3A (impurities)

Technical Guide for Container Closure Integrity of Chemical Injections

Note: Describes chemical generic drug registration via CDE.