Medical network - on February 16, on February 3, the Beijing municipal food and drug administration issued "about further strengthen the regulation of Chinese medicine yinpian production notice, for Chinese medicine yinpian enterprise dealing with traditional Chinese medicinal materials, auxiliary materials with the batch number management, medicine packaging material implementation according to the batch number, crack down on unlicensed make production and sales of Chinese medicine yinpian, their behavior. For inspection of paraphrasing, tampered with, forge inspection results or data, using map or not in accordance with the inspection procedure specification, a heavier deal with according to law, if the circumstances are serious, the drug GMP serious defect, take back the pharmaceutical GMP certificate.
Notification is clear, the approval of the pharmaceutical production license "medicine GMP certificate" range of venues, facilities, equipment, without approval shall not engage in behavior that has nothing to do with research, production, sales. Strengthen the Chinese medicinal materials, processing with materials and drug packaging materials traceability management, Chinese medicine yinpian production enterprises must strictly according to GMP requirements and variety of production process planning organization, created the whole must be completed within the approved workshop, batch production records shall be timely, true and complete records of process.
Analysis of the personage inside course of study, the drug safety system introduced new regulations that will herald the 2018 relevant departments according to Chinese medicine, Chinese herbal medicine regulation will be more violent.
To improve the quality of Chinese medicinal materials from the source
Under the new rules, emphasis on traditional Chinese medicine yinpian production enterprises must strictly according to GMP requirements and variety of production process planning organization, processing must be completed within the approved factory all the way, batch production records should be timely, true and complete records of process.
Chinese medicine yinpian must the batch-by-batch inspection qualified rear can sale all items, high performance liquid chromatography, gas chromatography and other test equipment should have effective audit trail function, and implementation of rights management, microscopic, TLC, etc the results of the inspection items retained in image form.
In recent years, Chinese herbal medicine, Chinese medicine yinpian, the production and sale of counterfeit goods, dyeing doping, weight gain, beyond business events emerge in endlessly, causing more bad influence to the society, for the drug safety system to carry out special campaigns in 2016 times, found widely exist different degrees of shoddy, dyeing problem such as weight, doping ShiJia, illegal processing is very serious.
National food drug safety administration announced on February 8, "back in 2016, the national drug GMP certificate of statistics", according to the 2016 national 162 drug companies a total of 170 pieces of GMP certificate. Among them, there were 80 repossessed GMP certificate from Chinese medicine yinpian enterprise, accounts for nearly 50% of the proportion.
The personage inside course of study points out that the source management is fundamental to solve the quality of Chinese medicinal materials. Early middle medicinal materials procurement channels as a hub for the trade market in the countryside, medicinal herbs, has now developed to purchase authentic medicinal materials, in the front of the market, the future development direction is the base construction. "Spent a lot of energy on circulation field, were later work, must attach importance to cultivation of the rein, including provenance, environment, management, processing way."
Improving the drug can be traced back system
Stressed that the "notice" to strengthen traditional Chinese medicinal materials, processing with materials and drug packaging materials traceability management. Chinese medicine yinpian production enterprises should strictly carry out supplier audit, its procurement, for the parameter, bills, etc. Should be timely, true and complete. Chinese medicine yinpian enterprise internal response to the traditional Chinese medicinal materials, accessories with the batch number management, medicine packaging material implementation according to the batch number for tracking.
Along with the development of the national economy and people's health needs further improve, the demand of traditional Chinese medicine is more and more big, some valuable medicinal herbs or growth cycle long medicinal materials often appear periodically prices plunged, causing the production and sale of counterfeit goods, mix dye extracted after medical treatment even when the original medicinal herbs (slices) phenomenon.
Enhance the level of Chinese herbal medicine circulation modernization, to ensure the quality of Chinese medicinal materials circulation, to ensure the safety of people's lives and health is a priority. The ministry of commerce as early as October 2012, issued the general office of the ministry of commerce of the pilot implementation of Chinese herbal medicine circulation traceability system construction notice, decided in the pilot city of application of modern information technology and Internet technology, through electronic labels, product packaging with Chinese medicinal materials of Chinese medicinal materials, the production processing, the market circulation of origin, pharmacy use relevant information of electronic registration, to carry out the construction experimental unit of Chinese herbal medicine circulation traceability system.
Commerce Department officials said the market order, with the establishment of the Chinese herbal medicine circulation tracing system, traditional Chinese medicine modernization level of circulation will be raised to a new level, the quality safety of Chinese medicinal materials will also be more secure, the people will be more at ease.
Beijing municipal food and drug administration on further strengthen the regulation of Chinese medicine yinpian production notification
District bureau, directly under the branch, the relevant units:
In order to further strengthen the regulation of Chinese medicine yinpian production, to ensure the safety of drug quality, according to the pharmaceutical administration law of the People's Republic of China, the implementation regulations of the pharmaceutical administration law of the People's Republic of China and other laws and regulations, as well as the "pharmacopoeia of the People's Republic of China", "drug production quality management norms" and its appendix (hereinafter referred to as the pharmaceutical GMP), "Beijing Chinese medicine yinpian concocted norms" and other technical requirements, combined with the national Chinese medicine yinpian actual situation and the our city, now is our city Chinese medicine yinpian production regulation put forward the following requirements, please comply with them.
1 our city as well as Chinese medicine yinpian production sales varieties must be within the scope of its holdings in the period of validity of the pharmaceutical production license and the range of the pharmaceutical GMP certificate shall coincide.
2 Chinese medicine yinpian production enterprises shall not engage in the identity of the Chinese medicine yinpian producers of other production and business operation behavior, the approval of the pharmaceutical production license, the pharmaceutical GMP certificate range of venues, facilities, equipment, without approval shall not engage in behavior that has nothing to do with research, production, sales.
3 to crack down on unlicensed make production and sales of Chinese medicine yinpian, their behavior. To sell drugs without legal qualification units or individuals; Source of counterfeit drug purchase, fiction drug sales flow; Drug distribution, certificate (license), ticket (notes) invoice, along with the cargo counterparts, zhang (zhang, physical CaiWuZhang), physical (drugs), money (payment) can't agree mutual correspond, drug purchasing and selling stock record is incomplete, not real, production management behavior not back; In the approved production site (including warehousing, inspection) outside the case such as production, storage, sales yinpian (except by dispensing for the record the toxicity of Chinese medicine yinpian).
4 to strengthen traditional Chinese medicinal materials, processing with material and medicine packaging materials traceability management. Chinese medicine yinpian production enterprises should strictly carry out supplier audit, its procurement, for the parameter, bills, etc. Should be timely, true and complete.
Five Chinese medicine yinpian enterprise dealing with traditional Chinese medicinal materials, auxiliary materials with the batch number management, medicine packaging material implementation according to the batch number for tracking.
6 Chinese medicine yinpian production enterprises must strictly according to GMP requirements and the varieties of production and processing must be completed within the approved workshop, batch production records shall be timely, true and complete record process.
7 Chinese medicine yinpian must after each shipment all items on sale until they have passed the inspection, high performance liquid chromatography, gas chromatography and other test equipment should have effective audit trail function, and implementation of rights management and the microscopic, the results of the inspection items such as thin layer chromatography retention in image form.
Eight Chinese medicine yinpian production enterprises should focus on regulatory requirements and standards change and update, a supplement to the state food and drug supervision and administration bureau issued inspection method for project, will check before release of product risk assessment at the same time, encourage enterprises to increase non-statutory method used for testing.
9 verified by risk assessment, data accumulation and toxicity (not less than 30 batch of finished product in principle, except slices), traditional Chinese medicinal materials, intermediate products and finished products inspection project results can be a part of data transfer, but it must be clear in the form of file data transfer varieties and project, and every year, every variety generally should be not less than 3 batch transfer data and corresponding batch herbs slices the review of the project.
10 for inspection of paraphrasing, tampered with, forge inspection results or data, using map or not in accordance with the inspection procedure specification, a heavier deal with according to law, if the circumstances are serious, the drug GMP serious defect, take back the pharmaceutical GMP certificate.
11 Chinese medicine yinpian enterprise quality inspection laboratory scale and equipment should be adapted to production varieties, behind the project should be put on record of individual need to entrust the inspection can be carried out, the client must be batch for entrusted inspection items as a result, you should also keep inspection records, map and other related information, and to entrust inspection data authenticity and integrity is responsible for the project.
12 district bureau, Chinese medicine yinpian production enterprise shall be directly under the bureau into the key regulatory scope, will check and raid as a routine method in regulation. In accordance with the law in accordance with the rules strictly investigate violation behavior, Chinese medicine yinpian production enterprises suspected of a crime, transferred to public security organs shall be investigated for criminal responsibility in a timely manner. City bureau will also organize Chinese medicine yinpian flight check production enterprises, and the rc and directly under the supervision of the office work.
Beijing municipal food and drug administration
On January 24, 2017 |
