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China will implement an export drug catalog management system
Shao Mingli, director of China's State Food and Drug Administration (SFDA), announced on Thursday that the country will enhance oversight of pharmaceutical exports by introducing a catalog-based management system. The first batch of 10 drug categories will be subject to stricter export controls. This decision was made during the national food and drug supervision meeting held on the 30th, where Shao emphasized that the new approach aims to ensure quality and safety in drug exports.
According to Shao, the scope of the export regulation includes pharmaceutical preparations, raw materials used exclusively for producing such preparations, and excipients that meet medical standards. The goal is to maintain high-quality standards and prevent substandard drugs from entering international markets.
Zhou Yan, secretary-general of the China Pharmaceutical Industry Association, noted that the move may stem from concerns over the quality of Chinese pharmaceuticals exported to developing countries in recent years. These concerns have led to international skepticism, prompting regulators to take more control over the export process. However, Zhou also pointed out that as long as domestic production adheres strictly to Good Manufacturing Practices (GMP) standards, excessive export interventions may not be necessary. She added that importing countries already have their own regulations in place to assess the quality of foreign pharmaceutical products.
Wu Wei, deputy director of the SFDA, highlighted that China maintains strict control over chemical raw materials. Any substances not officially approved cannot be used as pharmaceutical ingredients. This level of oversight has been in place for many years and is considered more rigorous than in some developed nations. He also mentioned that the responsibility for regulating imported medicines lies primarily with the regulatory agencies of the importing countries. In China, imported drugs must undergo inspection and testing before being released into the market, ensuring that only safe and effective products are available to consumers.
In addition, Shao stated that companies listed in the export catalog must hold valid pharmaceutical production licenses and have registered their products. Exporters must also obtain a "Pharmaceutical Sales Certificate" and comply with formalities set by local authorities. Provincial food and drug regulatory bodies will conduct thorough inspections and reviews to ensure that only qualified manufacturers are allowed to export, maintaining the credibility of China’s regulatory framework.
Looking ahead, the SFDA plans to intensify its oversight of chemical raw materials in 2008. Collaborating with other government departments, it will conduct a comprehensive review of chemical manufacturing processes and develop new measures to improve supervision and address any existing issues. This initiative reflects the administration's commitment to upholding global pharmaceutical standards and enhancing the reputation of Chinese pharmaceutical exports.