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The State Drug Administration issued the "Regulations on the Administration of Drug Export Sales Certificates"
- Categories:National Regulations
- Author:
- Origin:
- Time of issue:2018-11-14
- Views:
The State Drug Administration issued the "Regulations on the Administration of Drug Export Sales Certificates"
- Categories:National Regulations
- Author:
- Origin:
- Time of issue:2018-11-14
- Views:
On November 13, the State Drug Administration issued the "Regulations on the Administration of Pharmaceutical Export Sales Certificates" (hereinafter referred to as the "Regulations").
According to international practice, in drug import and export trade, upon the request of the drug regulatory authority of the importing country, the drug regulatory authority of the exporting country shall issue a product credit certificate for the drug exporting enterprise of the country. The "Regulations" have made major adjustments and modifications on the basis of the original management regulations, and use the format of the certification document recommended by the World Health Organization to better integrate with international practices.
According to the "Regulations", the State Food and Drug Administration issues certificates for drugs that have been approved for marketing in my country. In addition, since the State Food and Drug Administration officially joined the World Health Organization’s International Trade Drug Certification Program on August 31, 2018, and signed a memorandum of understanding with the Pharmaceutical Patent Pool Organization on October 30, 2018, in accordance with the above-mentioned international cooperation agreement, For drugs that have not been approved for marketing in China, in response to the needs of international organizations and following relevant agreements, the State Food and Drug Administration can also issue relevant certificates to better meet the needs of UNAIDS and the World Health Organization to supply anti-AIDS and tuberculosis drugs to Africa .
The "Regulations" also emphasized that if the drug regulatory authority believes that the materials submitted by the company cannot fully prove the compliance of the drug production quality management regulations, it can conduct on-site inspections as needed. Those that do not meet the requirements of the drug production quality management regulations shall not be issued a "Drug Export Sales Certificate" and shall be dealt with in accordance with laws and regulations.
The State Food and Drug Administration stated that the next step is to collect data from various regions and display it on the bureau’s information platform for inquiries and social supervision by regulatory agencies in various countries, so as to help relevant countries import drugs from China’s regular pharmaceutical factories and further develop international efforts to combat counterfeit and substandard drugs. Cooperation.
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