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Published on 24/12/2025

China GCP 2020 Alignment and Approvals SOP

Department	Clinical Research
SOP No.	CS/NMPA-GCP/177/2025
Supersedes	N.A.
Page No.	1 of 24
Issue Date	28/08/2025
Effective Date	05/09/2025
Review Date	05/09/2027

Purpose

This SOP describes the procedures for aligning sponsor and investigator activities with the China GCP (2020) requirements and securing necessary approvals from the National Medical Products Administration (NMPA). It ensures compliance with regulatory and ethical obligations for clinical trials conducted in China.

Scope

This SOP applies to all interventional clinical trials conducted in China requiring approval or notification to the NMPA and review by Ethics Committees (ECs). It covers Clinical Trial Application (CTA) submissions, substantial amendments, safety reporting, essential document management, and inspection readiness under China GCP 2020.

Responsibilities

• Sponsor: Ensures CTAs, amendments, and lifecycle events are prepared and submitted in compliance with NMPA requirements.
• Principal Investigator (PI): Provides site-level documentation and ensures EC approval prior to trial conduct.
• Regulatory Affairs (RA): Manages interactions with NMPA and ensures acknowledgment and approval documents are archived.
• Clinical Project Manager (CPM): Tracks timelines, coordinates submissions, and maintains regulatory compliance logs.
• Quality Assurance (QA): Conducts audits of NMPA submission packages and verifies alignment with GCP 2020.

Accountability

The Sponsor’s Head of Clinical Research holds accountability for ensuring organizational compliance with China GCP 2020. The PI is accountable for ensuring site-level adherence to EC and NMPA requirements.

Procedure

1. Preparation of Clinical Trial Application (CTA)

1. Compile dossier including protocol, Investigator’s Brochure (IB), informed consent forms (ICFs), investigational product (IP) details, and investigator qualifications.
2. Ensure documents are translated into Chinese and verified for accuracy.
3. Maintain CTA Submission Log in TMF.

2. Submission to NMPA

1. Submit CTA electronically via NMPA submission portal.
2. Record acknowledgment receipt, reference number, and submission date.
3. Maintain all submission-related correspondence in TMF.

3. Ethics Committee Coordination

1. Ensure EC approval is obtained prior to trial initiation at each site.
2. Submit bilingual ICFs and patient-facing materials for EC review.
3. Record EC approval letters in ISF and TMF.

4. Amendments and Notifications

1. Classify amendments as substantial or administrative.
2. Submit substantial amendments to NMPA and EC prior to implementation.
3. Record approvals in Amendment Log.

5. Safety Reporting

1. Submit SAEs and SUSARs in compliance with NMPA timelines.
2. Prepare Development Safety Update Reports (DSURs) annually.

6. Inspection Readiness

1. Maintain essential documents in TMF and ISF in line with GCP 2020.
2. Prepare sites and sponsors for NMPA inspections.

7. Archiving

1. Archive CTA submissions, approvals, amendments, and safety reports for 15 years or per NMPA rules.

Abbreviations

• NMPA: National Medical Products Administration
• CTA: Clinical Trial Application
• EC: Ethics Committee
• PI: Principal Investigator
• IB: Investigator’s Brochure
• ICF: Informed Consent Form
• IP: Investigational Product
• QA: Quality Assurance
• TMF: Trial Master File
• ISF: Investigator Site File

Documents

1. CTA Submission Log (Annexure-1)
2. Amendment Log (Annexure-2)
3. EC Approval Tracker (Annexure-3)

References

• National Medical Products Administration (NMPA)
• ICH E6(R2) Good Clinical Practice
• ICH Efficacy Guidelines
• China Clinical Trial Registry

Version: 1.0

Approval

Prepared By	Checked By	Approved By
Name: Rajesh Kumar Date: 20/08/2025 Signature: __________	Name: Sunita Reddy Date: 22/08/2025 Signature: __________	Name: Dr. Meera Iyer Date: 28/08/2025 Signature: __________

Annexures

Annexure-1: CTA Submission Log

Date	Protocol No.	Submission Type	Reference No.	Status	Submitted By
05/08/2025	CHN-2025-01	Initial CTA	NMPA-CTA-001	Accepted	Rajesh Kumar

Annexure-2: Amendment Log

Date	Amendment	Summary of Change	Status	Submitted By
18/09/2025	Amendment 1	Updated inclusion criteria	Under Review	Sunita Reddy

Annexure-3: EC Approval Tracker

Date	Site	Protocol No.	EC Approval Ref	Status	Owner
20/08/2025	Peking Union Medical College Hospital	CHN-2025-01	EC-2025-023	Approved	Neha Sharma

Revision History

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
28/08/2025	1.0	Initial SOP for China GCP 2020 alignment and approvals.	New SOP created for NMPA and GCP 2020 compliance.	Head of Clinical Research

For more SOPs visit: Pharma SOP.