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Notice of the Comprehensive Department of the State Drug Administration on Doing a Good Job in the Supervision and Administration of Drug Exports During the Period of Epidemic Prevention and Control
- Categories:National Regulations
- Author:
- Origin:
- Time of issue:2020-04-03
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Notice of the Comprehensive Department of the State Drug Administration on Doing a Good Job in the Supervision and Administration of Drug Exports During the Period of Epidemic Prevention and Control
- Categories:National Regulations
- Author:
- Origin:
- Time of issue:2020-04-03
- Views:
Drug Administration Comprehensive Drug Administration (2020) No. 31
The Drug Administration of all provinces, autonomous regions, and municipalities directly under the Central Government, and the Drug Administration of Xinjiang Production and Construction Corps:
In order to implement the decision and deployment of the Party Central Committee and the State Council, strengthen the supervision and management of drug export quality during the epidemic prevention and control period, promote the facilitation of drug export, promote the high-quality development of China's pharmaceutical industry, and effectively maintain the image of manufacturing in China, the relevant requirements for strengthening drug export supervision and management are hereby notified as follows :
1. Strictly regulate the management of drug export certification
The provincial drug regulatory authorities shall comply with the "Drug Administration Law" and other laws and regulations and the former Food and Drug Administration's "Notice on Matters Concerning the Export of EU API Documents" (SFDA [2013] No. 10) and the State Food and Drug Administration The "Notice on the Administration of the Issuance of Pharmaceutical Export Sales Certificates" (Guoyao Jian Yao Guan [2018] No. 43) and other relevant regulations strictly regulate the export of EU APIs, certificates of export sales of drugs, anabolic preparations and peptide hormone exports Issuance and management of drug export certificates such as permits. Relevant drug regulatory authorities must comprehensively investigate the status of the certificate. For those who do not meet the certification conditions and requirements, and fail to comply with my country's Good Manufacturing Practice (GMP), the relevant drug export certificate shall be cancelled in accordance with the law. Do a good job in daily supervision after the State Food and Drug Administration has issued an import and export permit for narcotic drugs and psychotropic drugs.
2. Continue to strengthen drug production supervision
All provincial drug regulatory authorities should strengthen the supervision of drug marketing license holders and drug manufacturers in their administrative regions, urge the holders and drug manufacturers to organize production in strict accordance with drug laws and regulations and drug GMP, and urge companies to ensure that they export drugs The quality meets the requirements of the importing country, strengthens the legal awareness, strictly fulfills the contractual agreement, and properly responds to various risks. We must severely crack down on all types of violations of laws and regulations in the pharmaceutical production process, and take special measures. For violations involving supervision of other departments, they shall be promptly transferred to relevant departments for handling and notification; for suspected crimes, they shall be promptly transferred to public security organs.
3. Strictly implement the responsibilities of all parties
Drug marketing license holders and drug manufacturers who are responsible for drug quality and safety in accordance with the law shall strictly abide by the provisions of China's drug laws and regulations, and organize production in accordance with the technical standards of the importing country to ensure that their exported drugs meet the standards of the importing country (region) or Contract requirements. Under the leadership of the local party committee and government, the drug regulatory agencies at all levels should strengthen unified leadership, strengthen information reporting, and work closely with relevant departments according to their responsibilities, strive to form a good situation of multi-departmental joint management and social governance, and comprehensively promote drugs Standardized export management and healthy development.
Fourth, do a good job in resuming work and production related services
All provincial drug regulatory agencies shall, in accordance with the relevant arrangements of the Party Central Committee and the State Council, do a good job in the resumption of work and production of drug manufacturers during the epidemic prevention and control period. Do a good job in the management of drug export certification documents in accordance with their duties, improve internal processing procedures, reduce the processing time limit, promote online acceptance and certification, and make drug export certification data information public, and continue to facilitate the export of enterprises. It is necessary to organize investigations and coordinate to solve the problems and difficulties faced by enterprises in exporting drugs, report to the local people's government when necessary, and promptly notify relevant departments to study and solve them.
All provincial drug regulatory agencies should further improve their political positions, timely convey the spirit of this notice to drug export companies and industry associations in their administrative regions, strive to supervise and manage drug exports during the epidemic prevention and control period, and actively support the international community. Fight the epidemic.
National Food and Drug Administration
April 3, 2020
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