Local Testing Support for Generic Radiopharmaceuticals During ANDA Registration in China

Overview

A global radiopharmaceutical manufacturer had filed ANDA applications in China for two generic drugs. As part of the registration process, the Chinese regulatory authority required local testing of the drug samples at an official laboratory.

The manufacturer had no local presence in China and needed expert assistance to manage the entire local testing process efficiently and compliantly.

Key Challenges

• Complex sample importation and customs clearance requirements
• Need for analytical method transfer from a US laboratory to the Chinese laboratory
• Coordination of testing activities and timely response to authority queries
• Strict timelines to avoid delays in the overall ANDA approval

Seven-Step Local Testing Solution

1. Preparation and submission of analytical methods to the official Chinese laboratory.

2. Coordination of shipment of samples and reference standards, including confirmation of all import requirements.

3. Management of the analytical method transfer from the US laboratory to the Chinese laboratory.

4. Handling customs clearance and physical shipment of samples to the Chinese laboratory.

5. Responding promptly to all queries raised during the local testing process.

6. Providing continuous technical support to the Chinese laboratory until the official testing report was issued.

7. Managing all communication between the laboratory and the manufacturer to ensure smooth progress.

Results Achieved

• Local testing was completed successfully and on schedule.
• 100% compliance with Chinese regulatory requirements was maintained throughout.
• Standardized procedures delivered high efficiency and consistency.
• The manufacturer was able to rely fully on specialized local expertise for this critical registration step.

This case demonstrates how targeted local testing support enables foreign pharmaceutical companies to meet China’s stringent ANDA requirements for complex radiopharmaceutical generics without establishing a physical presence in the country.