Chinese Medicine Formula Granules Liberty Followed Policy，Market supervision is quietly strengthening。

 

  September 20，Shandong Food and Drug Administration issued the "Notice on Strengthening the Supervision of Chinese Medicine Formula Granules"，Reador: Pilot manufacturers for clinical use of traditional Chinese medicine formula granules (hereinafter referred to as pilot manufacturers)，It should be a Chinese medicine formula granular production enterprise approved by the former State Drug Administration。Non -pilot manufacturers must not produce，Non -pilot medical institutions shall not use Chinese medicine formula particles，Drug business enterprises must not operate Chinese medicine formula particles。

 

  This is the second province to issue a notice on the formula particles of Chinese medicine formulas in the recent province，August 22，Beijing Food and Drug Administration also issued a notice on further strengthening the supervision of Chinese medicine formula particles。Beijing Bureau said，They found in the daily supervision and inspection process，Individual pilot manufacturers sell Chinese medicine formula particles to unsmoumed medical institutions to use。According to relevant regulations，Currently Chinese medicine formula granules are still in the research stage of scientific research，The purpose of the notification is to regulate the research behavior of the research pilot research pilot research pilot of traditional Chinese medicine formula。

 

  December 24, 2015，Ping An Night in the West，The State Food and Drug Administration released a big gift package，Send a notice for the "Administrative Measures for Chinese Medicine Formula (Draft for Solicitation of Opinions)"，Among them, the most noticeable is，Formula particles will let go。March 1, 2016 is the deadline for soliciting opinions。

 

  Some people in the industry said，Now the formula particles market is indeed chaotic，The regulatory authorities are worried that it will be more chaotic。So，It is expected that the formula My stake betting appparticles Stake Sports Bettingwill be rectified before letting go、After the standards are improved and under strict access conditions, let go。This time，Shandong and Beijing issued notifications to strengthen the regulatory requirements of formulas，It should be related to the market rectification。

 

  This year，"Shanghai Securities News" once reported on the market promotion chaos of traditional Chinese medicine formulas with the topic of "Heilongjiang Hospitals Back to Duck Gate Formula Pilot Pilot Pilot Pilot Pilot Pilot Pilot Pilot".。After the report is published，The Medical Department of the State Administration of Traditional Chinese Medicine has instructed the province to conduct in -depth investigation of relevant Chinese medicine medical institutions，also requires special inspections to all Chinese medicine medical institutions in the province。

 

 Shandong Province: Drug companies must not operate

 

  In addition to reiterating the formula particles in Shandong Province, it can only be produced by pilot enterprises，Pilot medical institutions use outside，It also stipulates that drug business enterprises must not operate Chinese medicine formula particles。

 

  Delivery requirements，Pilot manufacturers distribute Chinese medicine formula particles to pilot medical institutions，It should strictly abide by the requirements of drug GSP。Pilot manufacturers are indeed difficult to directly distribute to pilot medical institutions，In principle, you can entrust 1-2 pharmaceutical wholesale enterprises in the province to store and distribute。The entrusted enterprise must meet the "Standards for Implementation of Pharmaceutical Modern Logistics Enterprises (Trial)" (Lu Food and Drug Supervision City [2011] No. 141)，With logistics and distribution capabilities covering the province。Pilot manufacturers respond to whether the distribution enterprise has the corresponding storage、Traffic conditions and execution of GSPs of Drugs are conducted strictly for strict review，and sign with the distribution company that contains entrusted storage and distribution scope、Entrusted period、Effective contracts of data information maintenance and management，Clarify the quality responsibility and the rights and obligations of both parties。

 

  Delivery enterprises shall be written in writing to be inspected by the commissioner and the food and drug regulatory authorities at any time、Comply with the relevant requirements of the GSP of the drug; the inspection report of the pilot manufacturer's Chinese medicine formula particles must be obtained，No inspection report or unqualified formula particles shall not be distributed;

 

  Pilot manufacturers、Pharmaceutical wholesale enterprises who accept commissioned commission should be entrusted、Entrusted storage and distribution business to confirm the filing，Attached to the distribution contract、List of medical institutions、Review of the distribution enterprise and the commitment of stake betting appstake online sports bettingthe distribution enterprise，Provincial Bureau announced on the portal website for commissioned distribution related situations。Unpacking，No Chinese medicine formula granules must not be delivered。

 

  Municipal bureaus in daily supervision and inspection，Should carefully verify the pilot medical institution、Delivery Enterprise Qualification、File status，The Chinese medicine formula granules allowed to be used、Product self -inspection reports submitted by the pilot manufacturer; urge the pilot medical institution to carefully carry out adverse reactions monitoring work，Report the bad reaction report in time;、Unit using Chinese medicine formula particles，It should be in accordance with the "Drug Management Law" and the implementation regulations、"Measures for the Supervision and Administration of Drugs" and other laws and regulations for investigation and punishment。

 

  Beijing: Kaisa Hospital

 

  Beijing Bureau Requirement，Food and Drug Supervision Bureau of each district、Municipal Food and Drug Administration directly under the branch bureaus to strengthen the supervision and management of pilot use of Chinese medicine formula particle medical institutions，Properly deal with problems found in daily supervision。Medical institutions that use the formula of traditional Chinese medicine formulas for pilot pilot pilots，According to the "Approval of the National Food and Drug Administration on the use of administrative penalties for administrative penalties for the operation and use of traditional Chinese medicine formulas in the operation of universalized units" (National Food and Drug Administration City [2006] No. 630)、"Approval on the Issues of Medical Institutions Use Chinese Medicine Formula Granules" (National Food and Drug Administration Market [2006] No. 640) and other regulations，Order it to rectify the time limit;，Investigation and punishment according to law。

 

  Please continue to follow the requirements for pilot manufacturers，Strengthen and standardize research pilot research: First, actively carry out research on quality standards for Chinese medicine formula particles，Ensure that the quality of the product is stable; the second is to carry out clinical pilot research on medical institutions applied by the enterprise and passed the filing，Make sure the safety of clinical trials，and urge relevant medical institutions to carry out related research work in accordance with the clinical pilot research plan signed by the two parties; the third is to complete the quality standard review specified in the document specified in the document & rdquo;、Pilot manufacturers of research work such as clinical pilot research and secondary and above Chinese medicine hospitals with research capabilities，Both sides can choose to carry out the pilot research work of traditional Chinese medicine formula particles，Reported to our bureau for record。

 

  To facilitate the public inquiry and the Food and Drug Administration of various districts、Municipal Stake Sports Bettingstake sports betting appFood and Drug Administration's direct branch bureaus supervision and inspection，Our bureau summarizes the 1-6 batch of medical institutions applied for and passed the filing since 2011.，List, see the attachment。Current，The "Administrative Measures for the Management Granules of Chinese Medicine Formulas" drafted by the State Food and Drug Administration has publicly solicited opinions from the society，Our bureau will follow up with the progress of national policy，Timely formulation and implementation of new regulatory policies in Beijing。

 

  Annex: Medical institutions applied for by the enterprise and use the pilot pilot to use the Chinese medicine formula particles:

 

  Beijing Kangrentang Pharmaceutical Co., Ltd.:

 

  Xiyuan Hospital of China Academy of Traditional Chinese Medicine、Beijing University of Traditional Chinese Medicine Dongzhimen Hospital、Dongfang Hospital of Beijing University of Traditional Chinese Medicine、Ophthalmology Hospital of the Chinese Academy of Traditional Chinese Medicine、Beijing Xuanwu District Traditional Chinese Medicine Hospital、Hu Guo Temple Hospital affiliated to Beijing University of Traditional Chinese Medicine、Beijing Gulou Traditional Chinese Medicine Hospital、Beijing Changping District Traditional Chinese Medicine Hospital、Beijing Shijingshan District Traditional Chinese Medicine Hospital、Beijing Fangshan District Traditional Chinese Medicine Hospital、Traditional Chinese Medicine Hospital of Mentougou District, Beijing、Traditional Chinese Medicine Hospital, Daxing District, Beijing、Traditional Chinese Medicine Hospital of Tongzhou District, Beijing、Beijing Huairou District Traditional Chinese Medicine Hospital、Traditional Chinese Medicine Hospital of Pinggu District, Beijing、Beijing Miyun County Traditional Chinese Medicine Hospital、Yanqing County Traditional Chinese Medicine Hospital、Beijing Tongzhou District Traditional Chinese and Western Medicine Bone Injury Hospital、Third Affiliated Hospital of Beijing University of Traditional Chinese Medicine、Beijing Wangfu Traditional Chinese and Western Medicine Integrated Hospital、Beijing Traditional Chinese and Western Medicine Integrated Hospital、TCM Hospital, Chaoyang District, Beijing、Beijing Fengsheng Traditional Chinese Medicine Orthopedic Specialist Hospital、Beijing Massage Hospital、Beijing Emperor City's femoral head necrosis specialist hospital、Wangjing Hospital of Wangjing Hospital of Chinese Academy of Chinese Medicine。

 

  Sichuan New Green Pharmaceutical Technology Development Co., Ltd.:

 

  Guang'anmen Hospital of Chinese Academy of Traditional Chinese Medicine、Beijing University of Traditional Chinese Medicine Dongzhimen Hospital、Dongfang Hospital of Beijing University of Traditional Chinese Medicine、Ophthalmology Hospital of the Chinese Academy of Traditional Chinese Medicine、Third Affiliated Hospital of Beijing University of Traditional Chinese Medicine、Beijing Gulou Traditional Chinese Medicine Hospital、Wangjing Hospital of Wangjing Hospital of Chinese Academy of Chinese Medicine、Beijing Traditional Chinese Medicine Hospital affiliated to Capital Medical University。

 

  Guangdong Pharmaceutical Co., Ltd.:

 

  Beijing Changping District Traditional Chinese Medicine Hospital、Beijing Shijingshan District Traditional Chinese Medicine Hospital、Beijing Fangshan District Traditional Chinese Medicine Hospital、Traditional Chinese Medicine Hospital of Shunyi District, Beijing、Beijing Guoji Traditional Chinese Medicine Hospital、Beijing Tongrentang Traditional Chinese Medicine Hospital、Yanqing County Traditional Chinese Medicine Hospital。

 

  Shenzhen Sanjiu Hyundai Traditional Chinese Medicine Co., Ltd.:

 

  Beijing University of Traditional Chinese Medicine Dongzhimen Hospital、Traditional Chinese Medicine Hospital of Pinggu District, Beijing、Yanqing County Traditional Chinese Medicine Hospital、Third Affiliated Hospital of Beijing University of Traditional Chinese Medicine。

 

  Jiangyin Tianjiang Pharmaceutical Co., Ltd.:

 

  Guang'anmen Hospital of Chinese Academy of Traditional Chinese Medicine、Wangjing Hospital of Wangjing Hospital of Chinese Academy of Chinese Medicine。