- Strict management and innovation drive the construction of efficient drug supervision chain in our province
- Registration management: innovation leads to drive new drug safety upgrade
- Production Supervision: multi pronged, no blank
- Market supervision — strictly control market access and crack down on illegal operation
Strict management and innovation drive the construction of efficient drug supervision chain in our province
In late March, the general office of the provincial government issued the implementation opinions on accelerating the innovation and development of the pharmaceutical industry.
It was proposed that Sichuan should accelerate the transformation and upgrading of the pharmaceutical industry, enhance its competitiveness, strive to achieve 250 billion yuan of sales revenue of the pharmaceutical industry by 2020, and build Sichuan into an important innovation highland, modern Chinese medicine industry base and health service industry base in China Policy for pharmaceutical enterprises to inject a huge force.
Strictly investigate, crack down and deal with strictly! Zero distance, zero loophole, zero tolerance! As the regulatory department of the pharmaceutical industry, the provincial food and drug administration carries out the most stringent supervision on drug safety, and at the same time, it intervenes in the new variety research and development, declaration and other links in advance, solves the enterprise’s technical problems through on-site office work, policy guidance and other ways, and supports the enterprise’s technological innovation to the greatest extent.
“Development is the first priority and safety is the first responsibility.” The relevant person in charge of the provincial food and Drug Administration said that wearing “protective clothing”, building a “firewall”, weaving a “safety net”, and boosting the healthy and rapid development of the pharmaceutical industry in our province with the help of innovation driven and safety upgrading.
Registration management: innovation leads to drive new drug safety upgrade
At the end of last year, under the strong support and careful guidance of the provincial food and drug administration, the “recombinant hepatitis B vaccine containing pre-S antigen” developed by Chengdu Institute of Biological Products Co., Ltd. was approved by the State Food and Drug Administration for clinical trials.
The vaccine is a class 1 new drug for preventive biological products. At present, there is no similar product on the market at home and abroad, which fills the market gap of similar products.
This is only a miniature of the innovation and development of the pharmaceutical industry in our province. According to statistics, in 2014, our province obtained 37 new drug production approvals, an increase of 30% compared with the previous year, ranking the second in China. Many new drugs broke many domestic and international records.
In addition to the vaccine, Sichuan Fengchun Pharmaceutical Co., Ltd. and Sichuan Institute of traditional Chinese medicine jointly applied for “chuanshegan flavonoid capsule” and Sichuan Kangding Jinzhu Pharmaceutical Co., Ltd. ‘Ranjiangduoji capsule’, a new Tibetan medicine new drug of Sichuan Kangding Jinzhu Pharmaceutical Co., Ltd., have been approved for the market successively, breaking the record of zero production approval for new Chinese (Tibetan) drugs in recent years in our province, which is an innovative Tibetan medicine in recent 10 years A breakthrough in R & D.
In terms of registration supervision, we explored the establishment of provincial and municipal (prefecture) drug registration supervision linkage mechanism, explored the “applicant blacklist” system, explored the new regulatory thinking of “emphasizing both pre approval and in-process and post supervision”, and cancelled the registration audit of more than 10 items in six categories, with the number of records reduced by 90% compared with last year.
We started the online filing and auditing work of domestic non special purpose cosmetics in the province, and put on record the registration information such as prescriptions, packaging labels and other registration information of more than 500 domestic non special purpose cosmetics produced in our province. We will accelerate the approval of drug registration and re registration.
The drug re registration office was established to take the lead in the second round of drug re registration nationwide. At present, 1201 drug re registration applications have been accepted and 560 have been completed.
Production Supervision: multi pronged, no blank
The coverage rate of daily inspection, sampling inspection coverage rate of bid winning varieties of local production enterprises and electronic supervision coverage rate reached 100%.
“Three 100%” ensures the safety of drug production. During the 10-month special rectification of drug safety (including cosmetics and medical devices), special rectification was carried out on illegal production of traditional Chinese medicine, chemical drugs, cosmetics and medical devices.
The inspection coverage of production enterprises reached 100%, that of business enterprises exceeded 60%, that of medical institutions and retail enterprises exceeded 30%, and that of serious illegal production and operation enterprises reached 100% It was included in the “blacklist” and published.
The special rectification has achieved remarkable results. A number of illegal cases were investigated and dealt with, such as purchasing and using extracts under non GMP conditions and from illegal channels, processing and producing Chinese herbal pieces not in accordance with the processing specifications or beyond the approved scope, using illegal packaging materials of chemical raw materials and excipients that do not meet the pharmaceutical requirements, and using chemical raw materials to produce drugs, which effectively purified the drug production market.
At the same time, in the daily supervision, we carried out “flight inspection” on Chinese patent medicine and Chinese herbal pieces, inspected 78 Chinese patent medicine production enterprises and 45 Chinese medicine decoction pieces production enterprises, found 487 defects, interviewed 2 problematic enterprises, recovered 2 enterprise GMP certificates, and filed 12 cases for investigation.
At the same time, our province has also strengthened the construction of pharmaceutical enterprise credit system and risk assessment system. We have conscientiously implemented the quality credit rating and classification management system for pharmaceutical manufacturing enterprises,
implemented the quality credit rating assessment of the first batch of enterprises, completed the newly revised provincial GMP certification work on time and in quantity, guided Sichuan Huiyu and Chengdu shengnuo to pass the international GMP certification inspection, and took the lead in drafting and printing the provincial drug quality and safety risk study and judgment regular meeting system, so as to timely prevent and control the drug quality Provide risk warning for potential safety hazards.
Market supervision — strictly control market access and crack down on illegal operation
In recent years, the provincial food and drug administration has actively promoted the reform of the administrative examination and approval system, and implemented the “two certificates in one” in the change, renewal and certification of “drug business license” and “drug trading quality management standard certificate”.
In strict accordance with the law and procedures, 1143 drug wholesale enterprise business licenses were approved, 29 drug wholesale enterprise business licenses were cancelled, and 44 Internet drug service qualification certificates were approved. In 2014, 420 drug wholesale enterprises were certified by GSP. There are 10858 retail enterprises with GSP certification.
Strengthen the daily supervision, carry out “light sword” operation, “flight inspection” and cosmetic market investigation. A total of 72107 drug trading enterprises and medical institutions were inspected in the province, and 4046 illegal business operations were investigated and dealt with. We will focus on cracking down on illegal drug sales through illegal channels, “affiliated operation” and “ticket passing”, illegal drug sales on the Internet, the use of expired drugs and counterfeit drugs by rural pharmacies and medical institutions.
We have organized several inspections and secret visits to Chengdu Hehuachi traditional Chinese medicine market and retail pharmacies in some cities, prefectures and counties in the province. We will establish a unified information platform for cracking down on counterfeit medical devices in the province To improve the detection rate and investigation rate of cases, 4364 medical device enterprises and users were inspected in the “five rectification” of medical devices.
The number of cases investigated and transferred ranked first in the country, the number of inspection objects and the amount of fines and confiscations ranked second in the country, which effectively purified the market. (reporter Zhou Wei)
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