API Registration in China

Registration of API in China

With the rapid development of the pharmaceutical industry in China and the improvement of related regulations, API registration in China is becoming complex. Compared to the past when the final dosage form dossier was submitted with minimal API information required, pharmaceutical companies manufacturing outside of China are now required to submit a complete Drug Master File (DMF), including restricted component information and more. The API registration process is based on several regulations, including the Management Measures for Drug Registration (Decree 27) (issued in March 2020), the Drug Registration Fee Schedule (issued in June 2020), the Drug Registration Inspection Procedures and Technical Requirements Specification (Trial) (issued in July 2020), and the Drug Registration Verification Inspection Initiation Procedures (Trial) (issued in December 2021).

According to Order No. 27, the Center for Drug Evaluation (CDE) may conduct the related review and approval of the chemical raw materials used in the preparation when reviewing the application of the preparation. In addition, the applicant can apply for separate review and approval for the API used in the imitation of domestically marketed preparations.

About Us

Our company provides API registration services for clients and helps them obtain the approval of Chinese regulatory authorities for their products.

The regulations related to API registration in China have changed. To help our clients cope with the complex registration process, our professional regulatory affairs team provides comprehensive regulatory consulting services including filing, registration, change, and annual report for API registration in China for clients within China and outside who need to submit documents to the Chinese regulatory authorities. Our team communicates directly with our clients and the National Medical Products Administration (NMPA) to ensure a smooth review and final approval process.

Our API Registration Services

Although the filing modes of domestic APIs and imported APIs are different, there is no substantial difference in the whole cycle of registration and declaration from R&D project approval to registration declaration to market. Our company provides registered agent services for clients, including but not limited to:

• API registration agent services in China
• Provide a list specifying all the materials required for registration and templates of supporting documents
• Gap analysis and risk assessment of registration dossiers
• Preparation of supplementary information if necessary
• Review, translation, improvement, preparation, and submission of registration dossiers
• Application and progress tracking of sample testing
• Track the progress of API registration and CDE review
• Actively communicate with reviewers and respond to official questions
• Guide the preparation and submission of supplementary information during the CDE technical review
• Provide on-site support for GMP inspection if necessary
• Submission of the application for change, including basic information changes, minor changes, moderate changes, and major changes
• Technical transfer of API registration data
• Preparation and submission of annual reports for registered APIs

Our API Registration Workflow

If you need help or have a question, please feel free to contact us for more details.