Industry news

State Food and Drug Administration said the need to strengthen the work of steri

Time：2017-04-16 11:54:53

      （1）Certification is not more than half, more than 60% production capacity

      Preliminary statistics, the national pharmaceutical producing enterprises four main formulations have 1028 sterile drug products, including large capacity injection, powder injection, freeze dry powder injection, small volume injection dosage form has through the certification of enterprises can supply 630 species, accounting for 61% of the total number of species. That is to say, although the number of certified enterprises accounted for the total number of enterprises is not more than half, but the production capacity is more than 60%. Taking into account a part of the original sterile drug production enterprises have not been produced for a long time, the actual proportion of the proportion to be higher than the. Large volume injection and freeze dried powder for injection or even reach 70%, certification is not the cause of drug supply shortage of Yu, is gradually digestion. From the pre certification, some enterprises promote the new revised pharmaceutical GMP resolute attitude has through higher production quality management level of the newly revised drug GMP certification business, some enterprises reached the international advanced level, and through the World Health Organization, and the United States, Europe and other developed countries drug GMP certification. From the overall situation, achieved through the implementation of the newly revised drug GMP, improve the quality of enterprise management level and risk control ability, promote the 。

      （2）Overcapacity is still outstanding 。

      State Food and drug administration proposed, the current sterile drug production enterprises in the new revision of the drug GMP certification process presents the outstanding production capacity, structural adjustment and other characteristics. From the data, China pharmaceutical production overcapacity situation is still outstanding, such as freezing dried powder injection only by less than 20% of enterprises, will be able to supply nearly 70% of the market demand, through the contrast between the ratio and the ratio of supply capacity larger, a full description of the China pharmaceutical industry structure, there is capacity issues. Therefore, from the industrial structure, productivity point of view, the implementation of the new revised Drug GMP, for the elimination of backward production capacity, promote the pharmaceutical industry to upgrade, adjust the industrial structure is very necessary. In addition, the drug production enterprises, because of the problem of operating conditions, the degree of attention is not enough or in the transformation, the newly revised drug GMP certification work remain a wait-and-see attitude, promote the new revised drug GMP certification of the slow progress. According to the current schedule and the time limit of the end of 2013, the second half of the year may appear to focus on the application for certification. General Administration pointed out that, taking into account the national certification inspection resources are limited, the time to apply for the enterprise may be affected.

      （3）Do not have the certification of qualified enterprises "

      On the next stage of drug GMP certification work, the State Food and Drug Administration said, never lower the standard certification, in order to safeguard the fair competition environment in the pharmaceutical field, also on has not yet passed certification of enterprises no period of relaxation of the policy, display of drug administration in China raise the level, structure determination.

      n the second half of the certification peak may appear, the requirements of the General Administration on the one hand, in accordance with the order of the enterprise application is carried out in order to carry out the inspection, that is, the first application to check. On the other hand, the need for scientific allocation of resources, the market is in urgent need of varieties, can be properly arranged priority check. Do not have the conditions of the enterprise, to encourage the initiative to give up certification, properly deal with the aftermath, the formation of a mechanism to be able to enter, the survival of the fittest。