• Systematically compile, organize, and submit registration documents per regulatory requirements;

• Conduct gap analysis and compliance review of registration materials, including but not limited to process validation, structural confirmation, stability studies, and critical data integrity verification;

• Track official review progress in real-time, promptly respond to deficiency letters, and complete technical revisions;

• Full-process follow-up for sample registration testing (if applicable);

• Comprehensive support for registration on-site inspections/GMP audits (if applicable);

• Maintain updates to active pharmaceutical ingredient (API) registration documents, prepare and submit annual reports.

1. Definition and Background

Domestic API registration refers to the filing and record-keeping process for Active Pharmaceutical Ingredients (APIs) manufactured in China, as required by the National Medical Products Administration (NMPA), to ensure compliance with regulatory standards for quality, safety, and efficacy. Under the Drug Administration Law of the People's Republic of China and the Drug Registration Regulation, APIs are subject to a registration system. Drug product manufacturers must reference registered API information when submitting drug registration applications.

2. Applicable Scope

Domestically produced chemical APIs: Chemical APIs manufactured in China for use in drug product manufacturing.

Registration types: Includes initial API market registration and post-approval variations.

3. Basic Requirements

API registration requires submission of complete technical documentation, covering:

General information: API name, structure, physicochemical properties, manufacturer details.

Manufacturing process: Synthetic route, process controls, critical steps/parameters.

Quality control: Specifications, analytical methods, impurity profiles, stability data.

Non-clinical/clinical data (if applicable): Toxicology/pharmacology data (required for new APIs).

Packaging & storage: Materials, storage conditions, shelf life.

4. Registration Process

1）Document preparation: Compile technical files per NMPA’s M4: Common Technical Document (CTD) for Human Drug Registration.

2）Application submission: Submit registration forms via CDE’s "Applicant Portal" and mail electronic copies.

3）Formal review: CDE assesses completeness/compliance; approved applications receive an "I" status registration number.

4）Technical review: Eligible APIs proceed to technical evaluation.

5）Comprehensive review: Approved APIs’ status updates from "I" to "A".

5. Regulatory Basis

Drug Administration Law of the People's Republic of China

Drug Registration Regulation

M4: CTD for Human Drug Registration

*Note: Primarily describes chemical API registration via CDE.