2016-02-22 14:03
Food and Drug Administration: the abolition of electronic regulatory code conversion drug traceability system
[direct reporting network Beijing on February 22nd news] (surging News) on Saturday (20 days) afternoon, food and drug administration official website two bursts of news.
A is announced the suspension of the implementation of drug electronic supervision, on the grounds that the revision of "drug operation quality management standards" (hereinafter referred to as GSP) are related to the drug electronic supervision content being published for public comment; another is to solicit public opinions on the revision of the "standards for quality control of pharmaceutical business".
Reporter noted that the food and Drug Administration released the draft only a modification, that is "drug electronic supervision system modified for drug traceability system, and the abolition of mandatory implementation of the electronic supervision code scan code and data upload.
Previously, the food and Drug Administration for mandatory drug electronic supervision code, Hunan Pharmaceutical company sued to the court, which triggered drug electronic supervision code stored waste dispute.
The new drug GSP was implemented in July last year.
February 20, the food and Drug Administration in the notice of soliciting opinions wrote, "after listening to the part of the pharmaceutical producing enterprises, pharmaceutical trading enterprises, the relevant industry associations and experts opinions based on, the food and Drug Administration drafted" drug operation quality management standards "(Revised Draft), is now open to the community to solicit opinions". All sectors of the community can be in March 2016 23, the draft amendments to the views and recommendations.
Is the need for revision, the food and Drug Administration in published about "drug operation quality management standards" (Revised Draft) points out, released in January 2013, "drug operation quality management norms" and 2015 after the revision of the administration of the pharmaceutical quality management specification of pharmaceutical trading enterprises execute drug electronic supervision regulations and implement enterprise traceability requirements related to the main responsibility does not match, it is necessary to the relevant provisions of the current GSP drugs accordingly revised and improved.
Stated in the introduction, the revision of the work will be adjusting the drug electronic supervision and management system for the pharmaceutical traceability system, with the main responsibility for outstanding enterprises for independent construction, and the abolition of mandatory implementation of the electronic supervision code scan code and data upload. Special provisions and regulations such as the varieties separately.
It is worth noting that the drug GSP in the past 3 years has been revised two times.
In 2013, the former Ministry of Health issued and implemented in 2000, the GSP was revised, the total number by 88 increased to 187, joined the drug electronic supervision related terms, put forward "enterprise print or affixed to the Chinese drug electronic supervision code", "of drug electronic supervision code scan code, and timely upload data to Chinese drug electronic supervision network system platform and other requirements.
In 2015, the food and Drug Administration of the Ministry of health in 2013, the Ministry of health in revision of the drug GSP again, and in July 1st of the same year, the total number of articles is still 187, retained the previous relevant provisions of the original drug electronic supervision. The amendments to the terms of the content change is not large, the biggest change is the release of the drug GSP specification by the Ministry of health has become the State Food and drug administration.
Public information display, China began to implement the drug electronic supervision from 2006, initially only in enterprise production and special drugs, basic drugs in implementation, through in drug packaging box printed electronic regulatory codes on the whole process of drug production, distribution, sales and implementation supervision.
January 1, 2016, electronic monitoring drug kinds from specific drugs, basic drugs extended to all drugs, the scope of regulation from production enterprise expansion to the drugs retail business and in accordance with the requirements of the food and drug administration, who did not meet the new revision of the GSP standard pharmaceutical trading enterprises, shall stop medicine business activities. This led to the drug retail industry against.
Pharmaceutical companies that will appeal to "seek explanation"
Previously reported, the clauses about drug electronic supervision in January 25, Hunan raising day and Pharmacy Enterprise Group Co., Ltd. (hereinafter referred to as raising day and due to dissatisfaction with the State Food and Drug Administration strong push drug electronic supervision code, be sued in court, ask the court to confirm that the State Food and drug administration enforce electronic supervision code of administrative act is unlawful; decree the State Food and drug administration immediately stop illegal behavior; to the State Food and Drug Administration formulated the "drug operation quality management standards" to review the legality ".
Days and kept sued the food and drug administration, the main reason is because of the food and Drug Administration issued Notice No. 1, 2015 mandating that pharmaceutical companies implementation of electronic drug monitoring, drug of printed drug electronic supervision code "see code must sweep.
Raising the day and the prosecution of food and drug administration, drug electronic regulatory code useful useless, the game has become increasingly high survival. Including Li, a number of pharmaceutical companies responsible person to accept the surging news interview, has said that the drug electronic supervision code does not prevent counterfeit and substandard drugs, belonging to the costly duplication of construction, increase the burden on enterprises.
But managers think electronic supervision code can real-time monitoring Fuma drugs to combat counterfeit drugs.
February 5th, the admissibility of the case of Beijing City, the first intermediate people's court, the lawsuit is not in the scope of the court's administrative proceedings by the case, the court ruled against the case.
Acting lawyer Wang Xing said at the time of the case to the surging news, the day and ready to raise the appeal.
February 20, Wang Xing to surging news said, although the food and drug administration to take a positive attitude, take the initiative to stop the execution of the legitimacy, rationality, necessity, economy and effectiveness aspects there are serious problems of electronic monitoring code system, but will not abandon the appeal. "Response and practices of administration is still not completely solve the problem, and the judiciary should be legal face this relationship to the national economy and the people's livelihood authoritative evaluation, supervision and administration in accordance with law and prevent similar problems appeared again, instead of just focusing on 'trouble'. So, we still need to continue to make a "statement" ".
Interpretation of the news hot spots, showing sensitive events, more exclusive analysis, as in the "direct" micro channel, scan two-dimensional code free reading.
|