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

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.

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.

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.

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.

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 CDE's website

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).