Food drug safety administration of strengthen the regulation of traditional Chinese medicine extract ordered drug firms to make production

Time: 2016-01-04

Source: Beijing,

In addition, 31 dec For traditional Chinese medicine extraction, according to food drug safety administration website link the existence prominent question, the state food and drug supervision and administration bureau in July 2014, issued on the strengthen supervision and management in the production of traditional Chinese medicine extraction and extract notice (food drug drug safety supervisor [2014] no. 135, hereinafter referred to as the no. 135), has been clear about the traditional Chinese medicine extraction and extract the management requirements and provisions of the transition. Since January 1, 2016, who do not have the corresponding extraction ability of proprietary Chinese medicine production enterprises must stop production, production and use of traditional Chinese medicine extract must for the record.

Since January 1, 2016, who do not have the corresponding extraction ability of proprietary Chinese medicine production enterprises must stop production. The provinces (autonomous regions and municipalities) food and drug administration should be in accordance with the requirements of the no. 135, halted approvals for traditional Chinese medicine extraction processing. Extraction of traditional Chinese medicine (TCM) has been approved for processing for pharmaceutical producing enterprises must stop since January 1, 2016 commissioned extraction. Before to do not have Chinese traditional medicine processing and extraction ability of proprietary Chinese medicine production enterprises, since January 1, 2016, stop the corresponding varieties of traditional Chinese medicine production. Overdue don't stop production, the food and drug supervision and administration department on the basis of the "drugadministration law of the People's Republic of China" (revised in 2015, the same below) the seventy-eighth regulation serious investigation.

Since January 1, 2016, the production and use of traditional Chinese medicine extract must for the record. Since January 1, 2016, the proprietary Chinese medicine prescription item download Ming national drug standards, and has a separate national drug standards of traditional Chinese medicine extract for the record management. Every production or use of the traditional Chinese medicine extract enterprises, must be in accordance with the record management detailed rules for the implementation of a Chinese medicine extract (see file attachment no. 135) in the provinces, autonomous regions and municipalities directly under the food and drug administration for the record. Every violation of provisions, use for the record, continual production of proprietary Chinese medicine of traditional Chinese medicine extract, the provinces (autonomous regions and municipalities) food and drug administration on the basis of the "drugadministration law of the People's Republic of China" the seventy-eighth regulation serious investigation.

The provinces (autonomous regions and municipalities) food and drug administration in accordance with no. 135 document of article 2 of article 7 and attachment requirements, strict censorship for the record the scope of the traditional Chinese medicine extract does not fall within the scope for the record shall not be put on record; Have the record must be cancelled.

To strengthen the supervision and inspection. The provinces (autonomous regions and municipalities) food and drug administration to strengthen the supervision and inspection, to carry out the supervision responsibility, should ensure that the above production enterprise production on time. Be determined in accordance with the law to check found violation behavior is investigated, and in a timely manner to the public. Whoever does not have Chinese traditional medicine extraction ability of proprietary Chinese medicine production enterprises, issue a pharmaceutical production license shall not be produced (or equivalent; For production of traditional Chinese medicine extract enterprises alone, no longer issued by the pharmaceutical production license. State food and drug supervision and management of administration will further increase the strength and frequency of flight inspection, tracking, inspection, to investigate and expose illegal production behavior; For lax, poor supervision, will be criticized, and serious accountability.