SOP for institutional HGR approvals, SOP for trial sponsor data export, SOP for HGR lifecycle events”,
“articleSection”: “Standard Operating Procedure”,
“datePublished”: “2025-08-28”,
“dateModified”: “2025-08-28”,
“author”: { “@type”: “Organization”, “name”: “Clinicalstudies.in” },
“publisher”: {
“@type”: “Organization”,
“name”: “Clinicalstudies.in”,
“logo”: { “@type”: “ImageObject”, “url”: “https://www.clinicalstudies.in/logo.png” }
}
}

Published on 21/12/2025

Human Genetic Resources Approvals and Data Export Controls SOP

Department	Clinical Research
SOP No.	CS/NMPA-HGR/178/2025
Supersedes	N.A.
Page No.	1 of 26
Issue Date	28/08/2025
Effective Date	05/09/2025
Review Date	05/09/2027

Purpose

This SOP establishes the procedures for securing approvals for the collection, use, storage, and export of Human Genetic Resources (HGR) in clinical trials conducted in China. It defines sponsor, investigator, and institutional responsibilities to ensure compliance with Chinese HGR regulations under the National Medical Products Administration (NMPA) and the Ministry of Science and Technology (MOST).

Scope

This SOP applies to all clinical trials in China involving human biological samples or genetic data. It includes requirements for HGR licensing, ethics approvals, collaboration with foreign entities, restrictions on cross-border data and sample transfer, and record-keeping obligations. It covers sponsor-level submissions, investigator responsibilities, and site-level documentation.

Responsibilities

• Sponsor: Ensures HGR application submissions, approvals, and compliance with MOST regulations before trial initiation.
• Principal Investigator (PI): Collects and stores HGR samples at the site, ensures no unapproved transfers occur, and maintains accurate logs.
• Regulatory Affairs (RA): Manages submission of HGR applications and amendments to MOST and NMPA.
• Clinical Project Manager (CPM): Coordinates timelines, tracks HGR approvals, and ensures sites have valid certificates.
• Quality Assurance (QA): Audits HGR compliance at sponsor and site levels and ensures readiness for inspection.

Accountability

The Sponsor is accountable for securing and maintaining valid HGR approvals and ensuring compliance with Chinese regulations. The PI is accountable for maintaining site-level governance of HGR use and preventing unauthorized data or sample transfers.

Procedure

1. Identification of HGR Requirements

1. Determine whether the trial involves collection, storage, or export of HGR samples or data.
2. Document requirements in HGR Assessment Form (Annexure-1).

2. HGR Application Submission

1. Prepare HGR Application Dossier including protocol, consent forms, investigator CVs, sample management plan, and data export justification (if applicable).
2. Submit application to MOST before trial initiation.
3. Record submission details in HGR Submission Log.

3. Ethics Committee Coordination

1. Submit HGR-related documents to EC along with protocol and ICFs.
2. Ensure subject consent forms include clauses on HGR use and export restrictions.

4. Restrictions on Export

1. No cross-border transfer of HGR data or samples without prior MOST approval.
2. Maintain HGR Export Approval Log for each export event.
3. Ensure electronic data storage is localized in China unless export is specifically approved.

5. Amendments

1. Submit amendments to HGR approvals if study design, sites, or sample management plans change.

6. Documentation and Archiving

1. Maintain HGR Submission Log, Export Approval Log, and EC approval letters in TMF.
2. Archive HGR-related documents for at least 15 years or per Chinese law.

Abbreviations

• HGR: Human Genetic Resources
• NMPA: National Medical Products Administration
• MOST: Ministry of Science and Technology
• CTA: Clinical Trial Application
• PI: Principal Investigator
• EC: Ethics Committee
• RA: Regulatory Affairs
• QA: Quality Assurance
• TMF: Trial Master File

Documents

1. HGR Assessment Form (Annexure-1)
2. HGR Submission Log (Annexure-2)
3. HGR Export Approval Log (Annexure-3)

References

• National Medical Products Administration (NMPA)
• Ministry of Science and Technology (MOST)
• ICH E6(R2) Good Clinical Practice
• ICH Efficacy Guidelines

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: HGR Assessment Form

Protocol No.	Sample Type	HGR Involved	Export Required	Assessment By
CHN-2025-01	Blood DNA	Yes	No	Rajesh Kumar

Annexure-2: HGR Submission Log

Date	Protocol No.	Submission Type	Reference No.	Status	Submitted By
10/08/2025	CHN-2025-01	Initial HGR Application	MOST-HGR-001	Accepted	Sunita Reddy

Annexure-3: HGR Export Approval Log

Date	Protocol No.	Sample Type	Export Approval Ref	Status	Reviewer
20/09/2025	CHN-2025-01	Blood DNA	MOST-EXP-002	Approved	Neha Sharma

Revision History

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
28/08/2025	1.0	Initial SOP for Human Genetic Resources approvals and data export controls.	New SOP created for NMPA and MOST compliance.	Head of Clinical Research

For more SOPs visit: Pharma SOP.