Ji'nan pharmaceutical production and distribution enterprises sign quality safety "military orders"
August 24th news (reporter Zhen Zhen) today, our city convened a meeting to strengthen the supervision of the quality of basic drugs. The Municipal Food and drug administration has signed "basic" with 29 basic drug production enterprises in the city and 25 basic drug delivery enterprises. A commitment to the quality and safety of drug production and management. It is reported that all the basic drugs will be managed by the electronic regulatory code before March 31st next year. From April 1st next year, all non net and unused drug electronic regulatory codes will not participate in the procurement of basic drugs. Enterprises without electronic supervision will be eliminated from bidding for essential drugs distribution.
according to the survey, among the 307 National Basic drug varieties, there are 155 kinds and 29 enterprises in our city, with a total of 397 approval numbers, 216 kinds of supplementary varieties, 98 kinds and 20 enterprises in our city, with a total of 229 approval numbers. "Basic drugs are included in the coverage of Medicare reimbursement, and the reimbursement ratio is higher than that of non essential drugs, which also makes essential drugs a priority for patients." The head of the Municipal Food and Drug Administration said that, as the circulation of basic drugs is increasing, the scope of drug use is wide, and the production enterprises are many, once the quality and safety accidents occur, it will cause great harm to the public. This requires that the pharmaceutical manufacturers must achieve "zero error", and the listed drugs must achieve "zero failure rate". In the current state of the overall overcapacity of basic drug production capacity, the basic drug production enterprises in our city will also accelerate the merger and reorganization, bring about a significant adjustment of the circulation pattern of pharmaceutical enterprises, the production link may be concentrated to "one product and one factory", and the distribution link will be inclined to intensification, and the ring section is facing the countryside and the grass-roots level, some of the winning enterprises are in the bid. In the process of fierce competition, there may be a tendency to ignore the quality management of essential drugs. The scope of distribution enterprises may also neglect the storage and transportation of drugs.
for this reason, our city carries out full variety coverage, whole process monitoring and full project inspection of essential drugs. The production and inspection records of basic drugs shall be kept for one year after the expiration of the drugs, but not less than 3 years. The basic drug production enterprises should fully implement the system of drug quality recipients, organize production according to the approved production processes and prescriptions. If there are any changes, the registration or filing procedures of supplementary applications must be handled in accordance with the relevant regulations.
the drug regulatory department will carry out the verification of basic drug production processes and prescriptions and establish a verification work file. Without verification, enterprises shall not organize production; all the basic drugs are implemented electronically, and all the basic drugs are managed by the electronic regulatory code before March 31st next year, from April 1st next year. The network and the unused drug electronic regulatory code unify the identification, all must not participate in the basic drug bidding procurement; set up the distribution enterprise supervision files, and seriously investigate and deal with the illegal and irregularities such as "affiliated business", "go ticket", and sell fake drugs. The circumstances are serious, the distribution qualification is cancelled, and the distribution enterprise is carried out long distance. To monitor and control enterprises that have not implemented electronic supervision, to cancel the qualification of basic drug delivery bidding; to carry out the whole variety test for the basic drugs produced by the pharmaceutical enterprises in our city and to establish all the adverse reaction monitoring points in the medical institutions carrying out the basic drug system, and to have the risk hidden and illegal behavior but not in time. The enterprises that will be changed will take the most severe punishment measures and establish the "blacklist" system to expose the serious illegal and dishonest enterprises.