Drug Administration Clarifies Export Drug Safety Responsibility
2024. 9. 6
Recently, the Drug Administration has released the “Regulations on the Supervision and Administration of the Production of Exported Drugs (Draft for Comments)” and is soliciting opinions until September 10.
According to the “Regulations”, pharmaceutical manufacturing companies are primarily responsible for the quality and safety of exported drugs, ensuring that the entire manufacturing process complies with the relevant laws and regulations of both China and the importing country (region). It specifies that the production of exported drugs must strictly adhere to Good Manufacturing Practices (GMP), and the formulations, production processes, and quality standards registered and approved by the importing country (region).
Additionally, if different varieties or standards of exported drugs are produced at the same production site or production line, the regulations emphasize the need to strengthen production management, conduct risk assessments of the common line, and avoid any impact on product quality due to confusion, errors, contamination, or cross-contamination through measures such as physical isolation and staggered production times.
