New Regulations of China National Medical Products Administration-Key Information that Exporting Pharmaceutical Companies Must Know

On August 6, the National Medical Products Administration issued the "Regulations on the Supervision and Administration of the Production of Exported Drugs (Draft for Comments)", which detailed the production supervision requirements for exported drugs, including APIs and preparations. The scope of comments is until September 10, 2024.

Production requirements

The "Regulations" clearly state that drug manufacturers bear the main responsibility for the quality and safety of exported drugs and ensure that the entire process of drug production complies with the relevant laws and regulations of China and the importing country (region). Exported drugs should be produced in strict accordance with the drug GMP, the prescriptions, production processes and quality standards approved by the importing country (region).

In addition, if the same production workshop or production line produces different varieties and different standards of exported drugs, it should strengthen production management, carry out co-line risk assessment, and adopt physical isolation and time-divided production to avoid confusion, errors, contamination or cross-contamination, which will have an adverse effect on product quality.

Supervision and Inspection

The provincial drug supervision and administration department is responsible for conducting inspections on the production of exported drugs by drug manufacturers within its administrative area, and issuing export certification documents for drugs that meet the requirements upon application by the enterprise.

Provincial drug supervision and administration departments shall include drug manufacturers that produce export drugs in the scope of supervision and inspection, focus on the compliance of the drug production quality management system of the enterprise, and conduct supervision and inspection according to the principle of risk management. If necessary, supervision sampling can be carried out.

Export drug archives

Drug manufacturers shall establish export drug archives separately. Drug manufacturers shall use the drug annual report collection module to report export drug archive information to the provincial drug supervision and administration department of their location in accordance with the requirements of these regulations.

Summary

In recent years, the trend of China's innovative drugs going overseas has been hot. Although domestic pharmaceutical companies have advantages in cost-effectiveness and production speed, the differentiated supervision strategies of overseas regulatory agencies have made Chinese pharmaceutical companies face more challenges. The introduction of export drug production regulations is an important step for China's drug supervision to be in line with globalization, which will help accelerate the pace of innovative pharmaceutical companies to enter the international market.

Packaging, as a key link in drug export, is crucial to the safety and stability of drugs. Xinfuda is a pharmaceutical packaging material manufacturer dedicated to the global market. It has currently obtained 7 US DMF filings and passed the ISO15378 quality management system certification, providing strong support for many pharmaceutical companies' products to enter the international market. In the future, we will continue to uphold our original aspirations and help more pharmaceutical companies export their products overseas.