Hundreds of billions of chemical generic injection market will be "stirred"!

[pharmaceutical network industry trends 】In order to promote the consistency evaluation of quality and efficacy of chemical injection generic drugs, on October 15, SFDA solicited opinions from the public on technical requirements for consistency evaluation of quality and efficacy of chemical injection generic drugs (Draft for comments) and application data requirements for consistency evaluation of quality and efficacy of listed chemical injection generic drugs It can be seen from the documents that the technical requirements involve 11 parts, such as reference preparation, technical requirements for prescription process, technical requirements for quality control of the original auxiliary package, etc It is clear that sodium chloride injection, glucose injection, glucose and sodium chloride injection, water for injection, some radioactive drugs (such as technetium [99mTc]) and other varieties do not need to carry out consistency evaluation, but need to carry out quality improvement research Sterilization process, filter and package selection (including compatibility research) should meet the relevant technical requirements The requirements for application data involve two parts: application data items and description of application data items It can be seen that in the technical requirements, most of the chemical generic injection varieties need to be evaluated for consistency, except for the varieties that do not need to be evaluated for consistency Data shows that in 2016, the market scale of generic drugs in China was close to 800 billion yuan, and the market scale of chemical injection reached 576 billion yuan, accounting for nearly 80% of the market share This also means that with the promotion of the evaluation of the consistency of chemical generic injection varieties, hundreds of billions of chemical generic injection markets will be "stirred" In fact, according to the national ADR monitoring report every year, the varieties of chemical generic injections account for a considerable proportion, which causes great hidden danger to the safety of patients for injection, so it is urgent to strengthen the management and safety detection of injection varieties The evaluation of injection consistency has attracted the attention of the industry In May 2017, the State Administration issued the draft of relevant policies on encouraging the innovation of pharmaceutical medical devices to implement the full life cycle management of pharmaceutical medical devices, which clearly requires that the injection should carry out the consistency evaluation, and strive to complete within 10 years, but at that time, the detailed rules for the consistency evaluation of injection were not given By February 2018, the notice on Soliciting Opinions on technical requirements for conformity assessment of listed chemical generic drugs (injections) was issued, emphasizing that conformity assessment must be carried out for injections In general, the promotion of the quality and efficacy consistency evaluation of chemical injection generic drugs is conducive to further improving the drug use level of patients, ensuring the drug safety of patients, and improving the overall injection production technology level in China In addition, the industry pointed out that with the formal launch of the injection consistency evaluation, it means the opening of the drama, and some forward-looking enterprises have been on the road ahead of time According to pharmago data, as of April this year, there are 13 drugs that have passed (including deemed passes) the injection consistency evaluation (calculated by acceptance number, the same below), 473 are applying (deemed applications), and 31 are not approved It can be predicted that the promotion of quality and efficacy consistency evaluation of chemical injection generic drugs and the release of technical requirements for quality and efficacy consistency evaluation of chemical injection generic drugs will further point out the direction for injection evaluation of various enterprises, and the test of old injection varieties will also start!