600 billion injection market, big shuffle speed up!

On October 21, the Drug Review Center (CDE) of the State Drug Administration issued a Notice on Matters Related to Supplemental Information on Injection Consistency Evaluation (hereinafter referred to as "Notice"), pointing out that since the implementation of the evaluation of the consistency of chemical generic injections, the registration and declaration of some injection conformity evaluation varieties has obvious defects, and the relevant guiding principles require a large gap, and a large number of new research work needs to be carried out.
in addition, the Notice states that in order to implement the relevant requirements of the new Measures for the Administration of Drug Registration, further improve the efficiency of injection consistency evaluation, and optimize the review and approval process, enterprises shall, in accordance with the Measures for the Administration of Drug Registration, return written supplementary information within 80 days.
industry believes that the emergence of this document means that the 600 billion injection market reshuffle will speed up again.
fact, on May 14 this year, the evaluation of injection consistency was officially launched with the announcement issued by the State Drug Administration on the conduct of a consistent evaluation of the quality and efficacy of chemical injection generics.
, injection consistency evaluation has been one of the hot spots in the industry.
data show that in 2018, China's public medical institutions terminal injections have reached 588.2 billion yuan of sales scale, and in 2019 the market size of chemical injections has reached about 640 billion yuan.
with the launch of the injection consistency evaluation, the industry was widely expected to see a big change in the 600 billion market.
Now from the injection consistency evaluation guidance again landed, and the review speed greatly improved (completed within 120 days after acceptance), once the key factor of consistent evaluation, then the future inclusion of injections in the collection will become a matter of water, when the injection will officially enter the "national and provincial harvesting" division of the siege of the new stage.
It is worth noting that oral preparations can be sold in retail or online channels, and injection basic sales terminals are in the hospital, once due to non-evaluation and suspension of the network or no opportunity to participate in the collection, which means that the basic loss of the market, which also determines that the injection consistency evaluation declaration will be more intense than oral preparations, and once included in the collection, its price reduction will be greater than the oral preparation.
may also have a significant impact on sales of some of the drugs previously sold in domestic public health facilities.
in addition, the industry believes that the promotion of the consistent evaluation of chemical injections will also make China's chemical injection production enterprises increase research and development costs, in order to achieve high-quality standards, related production equipment, testing equipment also need to upgrade, in the short term, enterprise production costs will increase, pharmaceutical companies to improve product quality and development level is imminent, it is bound to appear more weak enterprises face the risk of elimination.
a long-term perspective, the industry has the strength of leading enterprises will win the development opportunity.
Overall, in the chemical injection consistency evaluation gradually perfect environment, the future concentration of China's chemical injection industry will be further improved, product quality will continue to improve, the industry pattern will continue to optimize.