China CDE Q&A on API Filing, Equivalence Evaluation, and Clinical Trial Registration

by Grace Wang
Nov 01, 2023

On October 26, 2023, China's Center for Drug Evaluation (CDE) released answers to seven frequently asked questions on three topics:

  1. DMF filing for active pharmaceutical ingredients (APIs)

  2. Equivalence evaluations for generic drugs

  3. Clinical trial registration

BaiPharm has provided a translated version of the Q&As for the convenience of foreign stakeholders. However, in the event of any inconsistency between the translation and the original Chinese version, it is essential to adhere to the original version issued by CDE.

1. DMF filing for APIs

Can the DMF filing person be changed during the review of the marketing authorization application for the API?

If there is a merger, acquisition, or split between companies without any technical changes to the manufacturing site, manufacturing process, and quality standards, the DMF filing person should be changed in accordance with the Procedures for Changes During the Review of Drug Registration Applications (Trial).

Specifically, in the case of a domestically manufactured active pharmaceutical ingredient (API), the manufacturer itself should assume the role of the filing person.

Is it necessary to include a commitment to updating certificate documents in the marketing authorization application dossier for overseas-manufactured APIs?

As per the Guidance for the Acceptance Review of APIs, the filing person is required to provide a commitment to accurately report to the Chinese regulatory authority about the changes to overseas regulatory information stated in the certificate documents. This includes information such as marketing authorization status, GMP compliance, etc.

2. Equivalence Evaluations for Generics

What is the background for the revision of the Guidance for the Acceptance Review of Equivalence Evaluation Applications for Generic Drugs?

The Guidance for the Acceptance Review of Equivalence Evaluation Applications for Generic Drugs (No. 148, 2017) was initially released in September 2017. 

Since its publication, various new policies have been introduced, such as administrative measures for equivalence evaluations for injections, electronic applications, and post-marketing changes.

To provide better guidance for the registration applications and acceptance of equivalence evaluations for generics, the decision was made to revise the existing Guidance. The revised draft summarizes key review points that were previously scattered across different policies. These key points encompass aspects such as application items for equivalence evaluations, reference listed drugs (RLDs), application dossiers, digital signatures, and more.

Is it a new rule that “CDE will no longer accept equivalence evaluation applications for generics if three years have passed since the first generic passed the evaluation?”

No, the rule in the question is not new, but rather it has been previously established in existing regulatory documents.

According to the Opinions on Conducting Quality and Therapeutic Evaluations for Generics (No. 8, 2016) issued by the State Council on March 5, 2016, in principle, for generics approved prior to the implementation of the reformed registration classifications, if the first generic successfully completes the equivalence evaluation, other generics containing the same API should complete the equivalence evaluation within a three-year timeframe.

Furthermore, the Notice on Implementing the State Council’s Opinions on Conducting Quality and Therapeutic Evaluations for Generics published by the former China Food and Drug Administration (CFDA) on May 25, 2016, explicitly stated that equivalence evaluation applications won’t be accepted for the generics with the same API as the first generic that passed the equivalence evaluation three years ago.

Related: China to Dismiss Overdue Equivalence Evaluations for Generics

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How to access the information regarding the generics that have successfully undergone equivalence evaluations?

To access the information regarding generics that have passed equivalence evaluations, you can visit the CDE's website at https://www.cde.org.cn/hymlj/index. On the website, you can navigate to the "Open Information" section, followed by "Chemical Drug Catalog". Look for the section labeled "Drugs that Have Passed Equivalence Evaluations" under the "Screening Tag" category. There, you will find the relevant information you are seeking.

searching-for-generics-that-have-passed-equivalence-evaluations-on-cdes-website.pngSearching for generics that have passed equivalence evaluations on CDE's website

3. Clinical Trial

Is it permitted to change the “Applicant’s Name” on the drug clinical trial registration and information publication platform?

The "Applicant’s Name" on the registration platform should be consistent with the name in the drug registration application form and clinical trial notice (clinical trial approval document or drug registration approval document). Changing the “Applicant’s Name” requires appropriate administrative documents, such as a clinical trial consent document, to approve the change. Without these documents, the change will not be permitted.

For detailed explanations regarding the “Applicant’s Name” on the registration platform, please consult the Guidance for Filling in Information for Drug Clinical Trials Registration (Version 2.0).

To facilitate the management of clinical trial registration information, the registration platform allows for the transfer of information by the registered applicant. Both the transferor and the transferee can check the transfer record in the main account at the "Applicant’s Window" on the registration platform. 

However, when the registration information is made public, the "Applicant’s Name" will not be changed, despite any registered transfer records. For steps to register the transferred information please refer to the Instructions for Use of Drug Clinical Trial Registration and Information Publication Platform" (Version 2.0).

Contact BaiPharm if you are interested in knowing more about China’s drug regulations.

Grace Wang
ChemLinked Regulatory Analyst & Editor
Copyright: unless otherwise stated all contents of this website are ©2024 - REACH24H Consulting Group - All Rights Reserved - For permission to use any content on this site, please contact cleditor@chemlinked.com
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