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Shao Mingli said at the national food and drug supervision and management work meeting on the 30th that the general idea of ​​export drug supervision is to implement catalog management, and the scope is limited to pharmaceutical preparations, raw material drugs used only for direct production of pharmaceutical preparations, and pharmaceutical excipients that meet medical requirements.
Zhou Yan, secretary-general of the China Pharmaceutical and Pharmaceutical Industry Association, said in an interview with this reporter that it may be due to the fact that the previous period has caused international doubts about the quality of China's exports of drugs to developing countries. Therefore, regulators are interested in strengthening export supervision.
However, she also believes that as long as pharmaceutical production is fully compliant with GMP standards in China, there is no need for too many export interventions, and China's pharmaceuticals still have relevant regulations for imported drugs in the importing country.
Wu Wei, the deputy director of the State Food and Drug Administration, also said recently that China's management of chemical raw material drugs is strict. Raw materials that have not been approved are not allowed to be directly administered as pharmaceutical raw materials. The administration of Chinese pharmaceutical raw materials has been used for many years and has been strictly enforced. Such strict management methods have not been done in some countries, including some developed countries. Second, the regulatory responsibility for imported drugs is mainly the responsibility of the drug regulatory authorities of the importing country. China has formulated special measures for the administration of imported drugs for medicines entering China. The imported medicines are subject to examination and inspection, and they are allowed to be released after being qualified. Therefore, China's regulations on import management are strict. However, in some countries, this may not be completely done. Imports do not need to be approved.
Shao Mingli also stated that the enterprises producing the varieties in the catalogue must obtain a pharmaceutical production license, and the variety must be registered; the enterprises in the export catalog must have appropriate qualifications and apply for export formalities with the “Pharmaceutical Sales Certificateâ€. The provincial food and drug regulatory authorities shall, in accordance with the principle of territorial supervision, earnestly review the clearance and entrusted inspections of good export drug qualifications, and maintain a good image of the regulatory authorities.
Shao Mingli also said that the State Food and Drug Administration will also strengthen the supervision of chemical raw materials in 2008, together with the development and reform and other departments to conduct a comprehensive investigation of the production of chemical raw materials by chemical companies, and study and formulate relevant supervision and remediation measures.
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Shao Mingli, director of the State Food and Drug Administration, said yesterday that China will strengthen the management of drug exports and implement a system of export drug catalog management. The first batch of 10 varieties will be subject to export supervision.