This is the second article in a series focusing on China Drug Master File (DMF) filing regulatory regulations and recent updates in the Chinese market.

Keywords: China DMF, API, Excipient, Packaging Material, Registration Strategy


 This article explores the detailed pathway options for China DMF registration, focusing on APIs, excipients, and packaging materials. It highlights the benefits and considerations of each pathway, providing DMF applicants with strategic insights to streamline their registration processes within China’s evolving regulatory framework. This content covered is essential for industry professionals seeking to understand and navigate the Chinese DMF registration requirements.

Pathway Options For Active Pharmaceutical Ingredients (APIs)

This article delves into three strategic pathway options and approaches that can be effectively employed to secure China DMF approval for your APIs:

  1. Binding Review and Approval Pathway: The API applicant submits a China DMF dossier to the CDE. If approved, an “Inactive” (I) China DMF filing number is assigned. During the drug product application, the CDE refers to the DMF number and changes the status to DMF “Active” (A) number upon approval.
  2. API Standalone Pathway: This independent standalone registration process allows the API to be reviewed and approved separately from the drug product, leading to an independent acquisition of the China DMF active number.
  3. Inclusion of API Dossier in Drug Product Dossier: In this approach, the API dossier is included with the drug registration documents, allowing for a streamlined review process while submitting additional information as needed.

Strategy 1: China DMF Binding Review and Approval Pathway

This strategy, the binding review and approval pathway, is the most common. The API applicant submits a DMF dossier to the Center for Drug Evaluation (CDE) for review. If approved, an “Inactive” (I) DMF filing number is assigned, allowing sample export to China for testing with NIFDC. During drug product registration (e.g., ANDA or NDA), the CDE reviews both the DMF and drug dossiers. Upon approval, the DMF status changes to “Active” (A) on the CDE DMF platform.

Binding review and approval pathway workflow (Figure 1)



Strategy 2: China DMF API Standalone Pathway

The second strategic pathway is for China DMF API standalone review and approval, an independent registration process similar to the EU CEP certificate. Under this pathway, the applicant receives a China DMF inactive filing number after the completeness review. The application then moves to the CDE’s technical review, enabling the applicant to obtain a China DMF active number. This China DMF active number is crucial as it allows the applicant to commercialize and distribute the API to multiple clients.

API standalone pathway workflow (Figure 2)



Strategy 3: A Combination of Two Pathways

Step 1: Inclusion of API Dossier in Drug Product Dossier

In this approach, the API dossier is included with the drug documents during the drug registration process, but submitted independently by the API supplier. At this stage, API sample testing is not required. The need for testing will be determined by the CDE based on a risk assessment or any issues found in the documents.

During the technical review, if the CDE identifies any missing API documents, they will issue a deficiency letter to the drug company. The API supplier can then directly submit the required information to the CDE.

Step 2: Standalone Pathway Filing

The first step helps the API applicant understand the CDE’s specific requirements. With this knowledge, the API applicant can confidently submit a standalone application for a China DMF active number. At this stage, the applicant includes a complete set of documents, fully meeting the CDE’s expectations. This standalone pathway filing is crucial for obtaining the China DMF active number, which allows the API to be commercialized and distributed to multiple clients in China.

Part of drug product registration + standalone pathway workflow (Figure 3)



Pathway Options For Excipient and Packaging Material Products

In the regulatory landscape for excipients and packaging materials in China, manufacturers have two primary pathway options:

  1. China DMF Binding Review and Approval Pathway: This pathway involves obtaining a DMF number.
  2. Part of Drug Registration: In this pathway, no DMF number is allocated.

For excipients and packaging materials, the most common and recommended option is to obtain a China Drug Master File (DMF) via the Binding Review and Approval Pathway.

Although including the excipients and packaging material dossier as part of the drug registration is an alternative pathway, this option also has critical drawbacks. It cannot guarantee the confidentiality of technical data, as all documents must be submitted through the drug company, risking exposure of confidential information. To safeguard this information, most manufacturers opt for the more secure route of applying for a China DMF number.

While options for excipient and packaging products may seem limited, a practical strategy can streamline the registration process. Documents can be updated any time before the binding review begins, offering more flexibility than API submissions. Manufacturers can address comprehensive gap closure or major defects before submission. Early decision-making allows for a customized approach aligned with project timelines.


As outlined, there are three distinct registration pathway options for API products and two for excipient and packaging products. Each pathway has its own set of advantages and considerations. It is crucial for applicants to carefully consider these factors when devising their strategies, ensuring they align with the unique circumstances of their projects.

The optimal pathway selection replies on a thorough evaluation of factors such as project timelines, available resources, confidentiality concerns, and the nature of the product itself. This customized approach maximizes the chances of regulatory success and expedites the approval process.

In conclusion, the diversity in registration pathway options for API, excipient, and packaging products requires strategic planning to avoid pitfalls and risks of delay. By carefully weighing advantages and considerations, applicants can craft tailored strategies that navigate the regulatory landscape in a timely and cost-effective way.


This article was prepared by April Wang from Accestra Consulting, which provides China Regulatory Affairs Consulting and Drug Master Filing (China DMF) for APIs, Excipients, and Packaging Material.

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