• Systematically compile, organize 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;

• Provide end-to-end follow-up for sample registration testing (if applicable);

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

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

1. Definition and Background

Pharmaceutical excipients and packaging materials (direct-contact materials) are critical components of drugs, directly impacting their safety, efficacy, and stability. Under China's Drug Administration Law and related regulations, excipients and packaging materials are subject to a registration/filing system. Manufacturers must submit registration applications to the National Medical Products Administration (NMPA) and pass review before use in drug production.

2. Applicable Scope

Excipients: Inactive ingredients in drug formulations (e.g., binders, stabilizers, preservatives).

Packaging Materials: Direct-contact materials (e.g., glass vials, plastic containers, aluminum foil, rubber stoppers).

Registration Types: Initial registration, etc.

3. Basic Requirements

Submit registration forms and technical documentation, including:

General Information: Name, manufacturer, quality standards.

Production Data: Manufacturing process, critical controls, validation.

Quality Control: Specifications, method validation (if required), stability studies.

Safety Data: Toxicological studies (excipients, if required); compatibility/safety studies (packaging).

4. Registration Process

1）Document Preparation: Compile files per NMPA Announcement on Improving Drug Correlation Review and Supervision (Attachments 1-2).

2）Application Submission: Submit via CDE’s platform and mail documents.

3）Formal Review: CDE checks completeness; approved applications receive "I" status.

4）Correlation Review: Technical evaluation; status updates to "A" if approved.

5. Regulatory Basis

Drug Administration Law of the People's Republic of China

Drug Registration Regulation

NMPA Announcement (Attachment 1: Excipient requirements; Attachment 2: Packaging material requirements).

Note: Describes CDE registration processes for excipients/packaging materials.