China Announces Technical Requirements for Overseas Approved Chemical Drugs Seeking Domestic Marketing Authorization

by Grace Wang Mar 09, 2021

On Mar. 8, the Center for Drug Evaluation (CDE) of China National Medical Products Administration (NMPA) issued the Technical Requirements for Chemistry, Manufacturing, and Controls Research and Evaluation of Overseas-marketed Chemical Drugs without Domestic Marketing Authorization 1.

The drug products to which the requirements apply mainly include two types:

  1. Class 3 chemical drug products: Chinese generic versions to original drugs approved abroad but not approved in China.

  2. Class 5 chemical drug products (exclude those whose original drugs are being marketed in China under the drug registration Class 5.2 overseas-marketed generic drugs): overseas-marketed drugs applying for China's marketing approval.

In addition, the requirements are also applicable to active pharmaceutical ingredients (APIs) in linked applications with those drugs mentioned above.

The Technical Requirement also mentions that applicants shall submit comprehensive and complete CMC (chemistry, manufacturing, and controls) research data according to the format in the current edition of M4 Organization of the Common Technical Document for the Registration of Pharmaceuticals for Human Use 2. For items not applicable, they should be indicated.

Overseas pharmaceutical companies could pay more attention to the Class 5 chemical drugs' technical requirements, including Class 5.1 original drugs being marketed overseas applying for a domestic marketing authorization and Class 5.2 generics (APIs and drug products included) being marketed overseas applying for a domestic marketing authorization. 3

When applying for marketing approval in China, overseas applicants shall submit the following application materials:

  • CTD reports on CMC studies.

  • The CPP certificate. It contains a brief history of major CMC changes (including changes approved by local drug administration, etc.), such as process improvement and quality improvement, which happened between the first approval and the time of import application.

  • Research data of CMC major changes when necessary.

Moreover, the applicant should provide data on batch samples to clarify the commonalities and differences between the drugs exported to China and marketed abroad in terms of production line, API, excipient, packaging material, pharmaceutical formulation, manufacturing process and quality control, including:

  • Critical clinical trial samples (e.g., overseas phase III trial samples and domestic clinical trial samples).

  • Importation inspection samples.

  • Technical verification samples.

In general, the Technical Requirements ask applicants to strengthen the pharmaceutical lifecycle management. It serves as technical guidelines for the pharmaceutical industry to develop drugs and regulatory agencies to conduct review and approval.

It is also a supporting document for the newly published edition of Provisions of Drug Registration. CDE completed and implemented the trial Technical Requirements in just five months after releasing its consultation draft. This indicates China's support for domestic pharmaceutical companies to speed up the study of overseas-marketed drugs and regulatory authorities to accelerate the review and approval of such products.  

Grace Wang
ChemLinked Regulatory Analyst
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