High threshold and elimination of substandard pharmaceutical enterprises

According to the State Food and drug administration, enterprises that fail to pass the new GMP certification can continue to sell products manufactured before December 31, 2013; products that have completed the final packaging before December 31, 2013, but have not completed the inspection, can continue to be inspected, and can only be sold after passing the inspection Sterile drug manufacturers or workshops that have passed the on-site inspection of newly revised GMP certification and have been publicized before December 31, 2013 can still continue production after January 1, 2014 However, its products can only be sold after obtaining a new GMP certificate According to the relevant regulations, since January 1, 2014, the production enterprises or workshops of sterile drugs such as blood products, vaccines, injections, etc that fail to pass the newly revised GMP certification will stop production For these companies, it's a blow in the head In addition to production suspension, enterprises that fail to pass the new GMP certification also face the blow of disqualification from purchasing in the bidding of new base drugs Officials of the national health and Family Planning Commission once stated that the new GMP is an important indicator in the quality evaluation of base drugs, and can even be "one vote veto" This means that the earlier the drug companies get the new GMP certificate, the more dominant in drug bidding It is reported that Qinghai, Shanghai and other places have stressed the "one vote veto" of the new GMP Those who fail to submit the new GMP certificate will be disqualified from winning the bid and will stop purchasing It is estimated that about 20-30% of enterprises that fail to pass the new GMP certification will eventually withdraw, especially some small enterprises can not stand the test of such a severe situation, and it is not a problem to withdraw 1200 enterprises It is understood that GMP 1998 has led to 25% of pharmaceutical companies directly leaving the market Guo Fanli, research director of China investment consulting industry research center, said that the high threshold of the new GMP drove out the substandard enterprises from the market, and ultimately benefited from the large pharmaceutical enterprises in the industry, because they have sufficient capital reserves and low-cost financing channels, so the transformation and upgrading are icing on the cake for them, and promote their growth and strength Some insiders believe that the implementation of the new GMP will affect vaccine enterprises for a while, but it has brought opportunities for injection manufacturers to adjust the variety layout and enhance the industrial concentration Taking large volume injection as an example, China's top five manufacturers have occupied nearly 50% of the national market share.