China Master Files are confidential filings submitted to CDE/NMPA to support a customer’s drug application without requiring the Master File holder to disclose proprietary technical information directly to that customer. China accepts Master Files for active pharmaceutical ingredients, pharmaceutical excipients, and packaging materials. Submissions must be prepared in Chinese, overseas holders require a local agent, and the file must be maintained through amendments, annual reports, and timely responses to agency inquiries.
Supplying an API, excipient, or packaging material for a drug application in China may require detailed information about how that material is manufactured, controlled, tested, and maintained.
That creates a challenge for suppliers. The regulatory authority needs enough technical information to evaluate the material, but the supplier may not want proprietary manufacturing information disclosed directly to its customer.
A Master File provides a way to address both needs.
The holder submits confidential information directly to China’s regulatory authorities. An authorized customer can then reference that file in support of its own application under review without receiving the holder’s complete proprietary dossier.
For overseas companies, the process also includes China-specific requirements for language, local representation, submission format, regulatory status, and ongoing maintenance.
Filing the Master File is therefore only one stage. Companies also need to manage customer authorizations, amendments, annual reports, agency correspondence, and long-term file maintenance.
What is a China Master File?
A Master File is a voluntary confidential filing submitted to a regulatory agency in support of another company’s application.
For example, an API manufacturer may supply an ingredient used in a customer’s new drug product. The regulatory authority reviewing that drug application will need detailed information about the API, including where and how it is manufactured.
Instead of providing confidential manufacturing information directly to the customer, the API manufacturer can submit that information in a Master File. The customer can then reference the file in its application.
In a Master File arrangement, the key parties are:
| Party | Role |
|---|---|
| Master File Holder | The person or company that submits and maintains the Master File |
| Applicant / Customer / Authorized Party | The company with an application under review that is authorized to reference the Master File |
The Master File supports the customer’s application while helping the holder protect confidential technical information.
Which agencies handle China Master Files?
Two organizations play important roles in China’s drug regulatory system.
National Medical Products Administration
The National Medical Products Administration, or NMPA, is China’s national regulatory authority responsible for the supervision and administration of drugs, cosmetics, and medical devices.
Its responsibilities include:
- Establishing regulatory requirements
- Establishing technical standards
- Overseeing product approval
- Supervising regulated products after approval
Center for Drug Evaluation
The Center for Drug Evaluation, or CDE, operates under NMPA and focuses on the scientific and technical evaluation of drug applications.
CDE reviews drug registration dossiers and evaluates areas such as:
- Quality
- Safety
- Efficacy
Its technical review supports NMPA’s regulatory decisions.
For Master File holders, CDE is central to the filing, review, correspondence, and lifecycle process.
What types of China Master Files can be submitted?
There are three primary China Master File types.
| Master File Type | What It Covers |
|---|---|
| API Master File | Confidential information concerning the manufacture, quality control, and specifications of an active pharmaceutical ingredient; suppliers may need API Master File support |
| Packaging Material Master File | Information for pharmaceutical packaging materials such as plastic bottles, trays, ampoules, and certain inhaler containers; suppliers may need packaging material Master File support |
| Excipient Master File | Information concerning pharmaceutical excipients such as flavorings, sweeteners, preservatives, and other functional ingredients; suppliers may need excipient Master File support |
The applicable requirements are not identical across these categories.
The file type can affect:
- Documentation requirements
- Submission format
- Filing fees
- Technical information included
- Ongoing maintenance
Companies should identify the correct file type before preparing the submission package.
What makes China Master File submissions different?
China has several requirements that distinguish its filing process from Master File systems in other markets.
Submissions must be prepared in Chinese
All Master File submissions to CDE/NMPA must be prepared in Chinese.
Supporting documents originally issued in another language may therefore require Chinese translation before submission.
Translation should not be treated as a final administrative step. Technical terminology, specifications, manufacturing information, and regulatory commitments need to remain consistent with the source documents.
Overseas holders require a local agent
An overseas Master File holder must appoint an agent.
The agent supports:
- Communication with CDE/NMPA
- Submission activities
- Regulatory correspondence
- Follow-up activities
For foreign companies, the agent remains relevant after the initial submission because agency questions, amendments, and ongoing maintenance may require continued communication with CDE/NMPA.
China uses an I and A status system
After submission and acceptance, the Master File is listed in the CDE database with an I status.
CDE’s public registration status terminology generally distinguishes between:
- I, or Inactive: The Master File is available for reference but has not yet completed linked review.
- A, or Active: The Master File has successfully passed linked review together with an associated drug application.
Receiving an ‘I’ status therefore does not mean that the linked review has been completed. The distinction is important for both the holder and customers that may want to reference the file.
What documents are typically included in a China Master File?
The exact requirements vary by Master File type, but China Master File submissions commonly include both administrative documentation and technical quality information.
Typical submission elements include:
- Submission Letter
- Application Form
- Table of Contents
- Manufacturing Details
- General Product Information
- Agent Appointment Letter
- Quality Information
- Statement of Commitment
- Contact Information
Submission Letter
The submission letter introduces the filing and identifies the type of submission being made.
Application Form
The application form contains administrative and submission information, including:
- Company name
- Address
- Contact person
- Email address
- Telephone number
- Submission information
Agent Appointment Letter
The holder must document the appointment of its agent.
For overseas holders, the agent’s appointment documentation should be prepared in a form acceptable for CDE/NMPA submission and may require formal authentication depending on the document type and submission circumstances.
Statement of Commitment
A Statement of Commitment is typically included to confirm that the submitted electronic files are free from viruses or malicious software.
Quality documentation
The filing also includes the applicable technical information about the material.
This may include:
- Table of contents
- General product information
- Manufacturing information
- Supporting quality documentation
The exact technical content depends on the type of Master File and applicable CDE requirements.
Is a Letter of Authorization required for the initial filing?
No.
A Master File holder does not need an authorized customer before submitting the initial Master File.
The Letter of Authorization can be submitted later when a drug applicant needs to reference the file.
When a drug applicant references the Master File in its application, the applicant generally submits the Letter of Authorization to CDE as part of the linked review process.
This allows a supplier to establish its Master File before every future customer has been identified.
For suppliers supporting multiple customers, Letters of Authorization should be managed carefully, so there is a clear record of which customers are permitted to reference the file.
Are there fees for China Master File submissions?
The fee structure depends on the Master File type.
| Master File Type | Filing Fee |
|---|---|
| Packaging Material Master File | No filing fee |
| Excipient Master File | No filing fee |
| API Master File | Application fee required |
Companies preparing an API Master File should include the applicable agency fee in their submission planning.
Current CDE/NMPA fee information should be confirmed before filing because fees and administrative requirements may change.
How are China Master Files submitted?
China Master File submissions are generally prepared for submission through CDE/NMPA-recognized administrative channels, which may include physical electronic media or electronic submission through the agency platform, depending on the file type and current agency requirements.
- An electronic copy compiled onto a CD and mailed to the agency
- An electronically compiled submission filed through the CDE submission portal
The submission format can also vary by Master File type.
| Master File Type | Common Submission Format |
|---|---|
| Packaging Material Master File | Typically, non-eCTD |
| Excipient Master File | Typically, non-eCTD |
| API Master File | Non-eCTD or eCTD |
Effective March 1, 2026, API Master File submissions can use either non-eCTD or eCTD format, which may increase the need for eCTD submission support during dossier preparation. Companies should also review current CDE eCTD guidance before compiling the dossier.
Companies should confirm the applicable format before compiling the dossier because the document structure and submission process differ significantly between non-eCTD and eCTD.
What is the difference between non-eCTD and eCTD?
Non-eCTD format
A non-eCTD submission uses a predefined CDE folder structure.
Documents must be placed in the sections specified by CDE and follow the agency’s document organization and formatting requirements.
Unlike eCTD, non-eCTD does not require:
- An XML backbone
- Sequence-based lifecycle management
Instead, an application number is assigned to the submission.
eCTD format
An eCTD submission organizes quality documents under internationally recognized Common Technical Document headers.
The format also uses sequential submission numbers to manage the filing lifecycle, such as:
- 0001
- 0002
- Subsequent sequences
China’s API Master File submission framework is moving toward broader use of standardized electronic submission formats, including eCTD, which supports more structured lifecycle management over time.
Administrative formatting also remains important.
Documents may require:
- Pagination
- Tables of contents
- Section headers
- Tables and figure headings
- Hyperlinks within files
- Hyperlinks across files
- OCR text recognition
These requirements help reviewers locate and move through information efficiently.
What happens after the Master File is submitted?
A China Master File needs ongoing maintenance after the initial filing.
Core lifecycle responsibilities typically include:
- Annual reports
- Contact information updates
- Quality information updates and Master File amendments
- Responses to agency inquiries
Annual reports
Annual reports should be submitted in the first quarter each year, where applicable.
The report contains information such as:
- Current contact information for Master File annual reports
- Amendments submitted since the original filing or previous annual report
Administrative amendments
An administrative amendment may be needed when information changes, including:
- Contact person
- Agent
- Master File holder name
The administrative information in the file should remain current.
Quality amendments
Changes to quality information may require an amendment.
Examples of quality-related changes that may require assessment or amendment include:
- Manufacturing process updates
- Addition of a new model
Agency inquiries
CDE/NMPA may request additional information at any time.
Communications may arrive through:
- Telephone calls
- Messages
- Letters
- The regulatory platform
The holder and agent should have a process for identifying these communications and responding promptly.
A file that was complete when submitted can become outdated if changes are not reported, or annual maintenance is missed.
What should companies check before filing?
Before compiling the submission, companies should confirm six areas.
1. Master File type
Determine whether the filing covers:
- API
- Excipient
- Pharmaceutical packaging material
The file type influences the documentation, format, and fee requirements.
2. Chinese-language documentation
Identify which source documents require translation and confirm that technical terminology remains consistent between the original and translated versions.
3. Local agent appointment
Overseas holders should have an agent arrangement in place, including the required appointment documentation.
4. Administrative documents
Confirm that the filing contains the required:
- Forms
- Contact information
- Appointment documentation
- Submission correspondence
- Statements
5. Submission format
Determine whether the filing will use:
- Non-eCTD
- eCTD
Then structure and format the submission accordingly.
6. Lifecycle responsibility
Identify who will manage:
- Annual reports
- Amendments
- Letters of Authorization
- Agency correspondence
- Deficiency responses
- Contact updates
A Master File needs a clear owner after the initial submission is complete.
How Registrar Corp can support China Master Files
China Master File submissions involve agency-specific administrative requirements, document formatting, Chinese-language coordination, secure communication, and ongoing filing responsibilities. Companies managing filings across multiple markets may also need global Master File services to keep submissions and lifecycle obligations aligned.
Registrar Corp can act as an authorized agent throughout the Master File lifecycle and assist with China Master File services, including:
- Secure agency communications
- Correspondence with the agency
- New submissions
- Amendments
- Deficiency response filings
- Annual reports
- Administrative updates
- Contact changes
- Letters of Authorization
- Coordination with qualified translation service providers
Registrar Corp can also compile and submit Master Files through its agency platform accounts. This can help companies avoid establishing and managing their own CDE accounts. Because the CDE platform and submission process are China-specific, overseas companies should plan for language, access, account setup, and administrative coordination before filing.
Customers can also securely access their filed submission data through Registrar Hub, helping maintain access to regulatory files when internal personnel or responsibilities change.
Scope of service: Registrar Corp provides administrative review and submission support to help ensure that the filing format meets agency requirements. The Master File holder remains responsible for the technical content being submitted.
Discuss Your China Master File Requirements
Frequently asked questions
What is a China Master File?
A China Master File is a confidential filing submitted to CDE/NMPA to support an application undergoing regulatory review. It allows the holder to provide proprietary information directly to the agency without giving the complete confidential dossier to the customer referencing the file.
What types of Master Files can be submitted in China?
China accepts Master Files for active pharmaceutical ingredients, pharmaceutical excipients, and pharmaceutical packaging materials.
Do China Master Files have to be submitted in Chinese?
Yes. Master File submissions to CDE/NMPA must be prepared in Chinese. Supporting documents issued in another language may need Chinese translation.
Does an overseas Master File holder need an agent?
Yes. Overseas holders require an agent to support submission, agency communication, correspondence, and follow-up activities.
What does ‘I’ status mean?
‘I’ status generally means the Master File is available for reference but has not yet completed a linked review with an associated drug application.
What does A status mean?
A status indicates that the Master File successfully passed linked review together with an associated drug application.
Is a Letter of Authorization required for the initial filing?
No. A Master File can be filed without an authorized customer. When a drug applicant later references the file, the applicant submits the Letter of Authorization to CDE.
Are there fees for China Master Files?
The fee position depends on the Master File type. Packaging material and excipient Master Files are generally not subject to filing fees, while API Master Files may require an application fee. Companies should confirm current CDE/NMPA fee requirements before filing.
Are annual reports required?
Yes. Annual reports are used to keep key Master File information current and should be submitted according to the applicable CDE/NMPA maintenance timeline, including first-quarter annual reporting where applicable.
Can a China Master File be updated after submission?
Yes. Administrative or quality amendments may be required when information changes. CDE/NMPA may also request additional information, and holders should respond promptly.
Closing – Keep the file ready for the application that depends on it
A China Master File protects confidential information while allowing customers to reference the material in applications under review. Filing the dossier, however, is only the first step.
The file must remain current, customer authorizations must be managed, annual reports must be submitted, changes must be reflected through the appropriate amendments, and agency questions require timely responses.
Registrar Corp can support the administrative side of the Master File lifecycle, from initial compilation and submission through amendments, annual reports, deficiency responses, agency communications, and Letters of Authorization.
⏱️ Your customer’s application should not be waiting on an administrative Master File issue.
Discuss your China Master File requirements with Registrar Corp.
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