On December 3, Wu Jun, the deputy director of the State Food and Drug Administration, spoke at a press conference organized by the State Council Information Office. He emphasized that China maintains a strict regulatory system for chemical active pharmaceutical ingredients (APIs). However, due to differences in how countries manage imported drugs, some regulatory gaps have emerged. This highlights the need for stronger international collaboration in drug supervision.
Regarding the recent global concern over the Panamanian TD glycerol incident, Wu Jun noted that while the issue has been addressed, the broader problem of chemicals used in drug exports remains a critical area of focus. The incident underscores the importance of cross-border cooperation in monitoring chemical substances.
Wu Jun also highlighted that China's regulation of API production is highly controlled. According to the "China Drug Administration Law," all APIs must be approved by the regulatory authority and obtain licenses and product approval numbers before they can be manufactured. Unapproved materials are strictly prohibited from being used as pharmaceutical raw materials. This system has been in place for years, unlike in some developed countries that adopt less stringent measures.
In addition, China has established specific administrative measures for imported drugs, ensuring thorough inspections before release. However, in some nations, drug imports do not require such rigorous approvals. These disparities in regulatory frameworks create loopholes that some companies may exploit. In today’s globalized economy, drug quality is no longer just a national issue—it has become a worldwide challenge.
To address this, Wu Jun stressed the importance of international cooperation. The State Food and Drug Administration has already signed a cooperation framework with EU organizations to enhance drug safety management. Additionally, China and the U.S. have held multiple discussions on drug safety, reaching mutual agreements on key issues.
Looking ahead, the administration plans to conduct a comprehensive audit of domestic chemical raw material manufacturers to assess their compliance and implement more targeted supervision. This move aims to strengthen oversight and ensure the integrity of the pharmaceutical supply chain.
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