Food and Drug Administration to extract Chinese medicine production from four to strengthen supervision and extracts

Source：       Time:2014-11-21 10:29:28     Clicks:163

With the scale and intensive development of Chinese medicine production, medicine or buy medicine extract extract more prominent part of the problems, to the quality of medicine safety and security. To strengthen the supervision and management of traditional Chinese medicine extract and extract, standardized behavioral medicine production, quality assurance of safe and effective medicine, Food and Drug Administration in the extraction and production of traditional Chinese medicine extracts from four to strengthen supervision.

One, is to regulate traditional Chinese medicine extraction behavior. Chinese medicine production enterprises must possess the ability to produce varieties of traditional Chinese medicine extraction and size-appropriate, in accordance with the provisions of the State Administration of Traditional Chinese Medicine extract entrust all to stop the province's approval process has been approved, you can continue working to this document is valid, should no longer apply after the expiration of continuation.

Second, is to carry out the production and use of traditional Chinese medicine extract record. Only approved prescription system of law based on traditional Chinese medicine extracts feeding species, before the use of the extract produced feed, production and use of the extract should be implemented in accordance with the requirements for record management.

Third, is the urge enterprises to implement quality responsibilities. State Administration quickly "on the strengthening of traditional Chinese medicine extract and extract production supervision and management of the notice" requirement communicated to the relevant enterprises and increase publicity and training efforts to improve the legal awareness of Chinese medicine production enterprises, sense of responsibility and sense of quality, and urge them to consciously implementation of the national bureau of the management requirements.

Fourth, is to strengthen the daily supervision. On the area of medicine production enterprises and extract manufacturing enterprises to establish appropriate regulatory archives, to develop regulatory plans, and conducting extended supervision or regular supervision, and constantly improve regulatory efficiency.