Shandong province: strengthen the regulation of traditional Chinese medicine formula particles, recordation shall not distribution

Time: 2016-09-22

Source: China's traditional Chinese medicine

Author: Tian Hongshun

Report from our correspondent a few days ago, shandong province food and drug administration issued a circular, to further standardize the province traditional Chinese medicine (TCM) formula particles to test work.

"Notice" requirements, one is in the province to carry out the traditional Chinese medicine formula particles of clinical use of pilot production enterprises (hereinafter referred to as the pilot production enterprises), should be approved by state drug administration of traditional Chinese medicine formula granules production enterprise. Other production enterprise shall produce and other medical institutions shall not use traditional Chinese medicine formula particles, pharmaceutical trading enterprises may engage in traditional Chinese medicine formula particles. Secondly, the pilot production enterprises to pilot distribution of TCM formula granules, medical institutions shall strictly comply with the drug GSP requirements. Pilot production enterprise distribution directly to the pilot has difficulty in medical institutions, the principle can be entrusted to 1 ~ 2 pharmaceutical wholesale enterprises in the province to storage and distribution. Be entrusted enterprise must conform to the standards on the pharmaceutical logistics enterprises in shandong province (trial) ", covering the entire province ability in logistics distribution. Pilot production enterprises dealing with distribution enterprises have corresponding storage, transportation and the implementation of drug GSP situation to carry on the strict censorship, and sign and distribution enterprises entrusted storage distribution scope, time limit, the data valid contract information maintenance and management of content, clear quality responsibility and the rights and obligations of both parties. Distribution enterprises shall written commitment to accept at any time to the inspection and the food and drug regulator, the drug GSP requirements; Must ask for the pilot production enterprise of traditional Chinese medicine formula particles inspection report, test report or substandard formula particles may not distribution; The commissioned distribution again commission shall not be accepted, Not to the recordation of the distribution of medical institutions; Shall not purchase, sales, traditional Chinese medicine formula particles. Three pilot production enterprises, is the authorized pharmaceutical wholesale enterprises shall, in accordance with the requirements of the distribution business entrusted, mandated storage confirmation for the record, and commissioned distribution contract and attached list of medical institutions, review the situation of distribution enterprises and distribution enterprises undertaking, ShengJu distribution information in the portal to entrust a public announcement. Delivery is not allowed without the record of Chinese medicine formula particles. Four is the metro in daily supervision and inspection, shall carefully check pilot, distribution enterprise qualification, medical institutions for the record, directory allows the use of traditional Chinese medicine formula particles varieties, pilot production enterprise products, such as the self-check report submitted content; Supervise the pilot medical institutions, adverse drug reactions monitoring in promptly reported adverse reactions report; To business unit, the use of traditional Chinese medicine formula particles without authorization, shall be on the basis of the pharmaceutical administration law and its implementing regulations, as well as the measures for the supervision and administration of the drug circulation law regulations for investigation.