On December 3, Wu Jun, the deputy director of China's State Food and Drug Administration, addressed a press conference hosted by the State Council Information Office. He emphasized that China maintains a strict regulatory framework for chemical active pharmaceutical ingredients (APIs). However, due to varying management systems and procedures across different countries, some regulatory gaps have emerged in the international supply chain of pharmaceuticals. Wu stressed that global cooperation is essential to address these challenges.
In response to the recent Panamanian TD glycerol incident, which has sparked international concern, Wu pointed out that while the issue was resolved, the broader problem of chemical substances used in drug exports remains a critical area of focus. The incident highlights the need for stronger international collaboration in monitoring and regulating chemical materials used in pharmaceutical production.
Wu also explained that China’s regulatory approach for APIs is rigorous. According to the "Drug Administration Law of China," all APIs must be approved by the national drug regulatory authority, obtain licenses, and receive product approval numbers before they can be manufactured. Unapproved raw materials are strictly prohibited from being used in pharmaceutical production. This system has been in place for years, unlike in some developed countries where regulations may be less stringent.
China has also implemented specific administrative measures for imported drugs, including thorough inspections and approvals before release. However, in certain countries, drug imports do not require such extensive scrutiny. These differences in regulatory approaches create potential loopholes, which some companies may exploit. Wu noted that in today’s globalized economy, drug quality is no longer just a national issue—it has become a global concern that requires collective action.
To enhance oversight, the State Food and Drug Administration has established cooperation frameworks with EU organizations and engaged in multiple discussions with the U.S. Food and Drug Administration on drug safety. These efforts aim to improve transparency and strengthen mutual trust between regulatory bodies.
Furthermore, the administration plans to conduct a comprehensive review of domestic chemical raw material medicine companies to assess their compliance and implement more targeted supervision. This initiative underscores China’s commitment to maintaining high standards in pharmaceutical production and ensuring the safety of medicines both domestically and internationally.
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