• Provide registration agency services for overseas API manufacturers;

• Pre-registration compliance consultation: Including but not limited to overseas document pre-review and market access strategy development;

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

• Systematic compilation, organization and submission of registration dossiers;

• Full-process tracking of official review progress, rapid response to deficiency letters and completion of technical revisions;

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

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

• Registration dossier change maintenance, annual report preparation and submission.

1. Definition and Background

Definition:

API import registration refers to the statutory process where overseas-manufactured Active Pharmaceutical Ingredients (APIs) must complete platform registration per technical requirements to obtain a registration number before entering the Chinese market.

Background:

Regulatory Requirements:

1）Per Drug Administration Law of the People's Republic of China and Drug Registration Regulation, APIs labeled "A" indicate successful review/approval. Registrants may print approval documents, quality standards, and labels from the platform for GMP inspections/customs clearance.

2）APIs submitted with drug product registration dossiers without platform registration will have relevant information noted in the drug approval documents for GMP/customs purposes.

Industry Needs:

Registration ensures API quality complies with Chinese Pharmacopoeia (ChP) or ICH standards (e.g., Q3A impurity control, Q11 development/manufacturing requirements).

2. Applicable Scope

Target Applicants:

APIs manufactured overseas/in Hong Kong/Macau/Taiwan for chemical drug production in China (sterile/non-sterile).

APIs requiring repackaging post-import (must submit repackaging process validation/stability data).

Scenarios:

First-time import to China;

Major changes to registered APIs (e.g., synthetic route changes, critical QC standard upgrades);

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

Exclusions:

APIs for R&D/non-clinical/clinical trials only (require Import Drug License).

3. Basic Requirements

Technical Documentation:

1）CTD-format Dossier:

Module 1: Application forms, Letter of Authorization (LOA), manufacturing site proof (GMP certificate/equivalence statement).

Module 2: Quality overall summary (2.3.S) covering manufacturing process, characterization, QC strategy.

Module 3: Detailed pharmaceutical data (3.2.S) including synthesis, structure confirmation, impurity profile, stability studies.

2）GMP Compliance Proof:

Notarized/legalized GMP certificates (or ISO 9000 for APIs regulated as food in origin countries) with Chinese translations.

4. Registration Process

1）Document Preparation: Compile files per NMPA’s M4: CTD for Human Drug Registration.

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

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

4）Technical Review: Eligible APIs proceed to evaluation.

5）Comprehensive Review: Approved APIs’ status updates 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: Describes chemical API import registration via CDE.