"Shuffling effect" of consistency evaluation: competition upgrading of three kinds of chemicals

Source: on April 1, 2016, CFDA forwarded relevant matters on the implementation of the opinions of the general office of the State Council on the evaluation of the quality and efficacy of generic drugs (Draft for comments) Once the draft is finalized, it will speed up the reshuffle of China's chemical industry Three main points of the draft 1 Clear scope of evaluation object, which will promote the development of drug consistency evaluation in China The previous policy on consistency evaluation mainly refers to the generic drugs approved for listing before the implementation of new registration classification of chemical drugs If the generic drugs are not approved according to the principle of consistency with the quality and efficacy of the original drugs, the consistency evaluation must be carried out The draft makes clear the scope of evaluation object of consistency evaluation, which includes not only domestic generic drugs, but also imported generic drugs and original research drugs This means that both the imported generic drugs and the original developed drugs should participate in the consistency evaluation, which will promote the original developed drugs to share the data of the original developed drugs, and the imported generic drugs that have been listed in Europe, the United States and Japan to share their foreign clinical research data The acquisition of the above data will greatly promote the development of the consistency evaluation of drugs in China 2 For non base drug oral drug products, the "three-year" time limit consultation draft was reiterated once again, which announced the list of generic drug conformity evaluation varieties to be completed by the end of 2018, that is, 292 generic drug names of chemical generic oral solid preparations listed in the national basic drug list (2012 Version) approved for marketing before October 1, 2007 It is worth noting that the dosage forms of dry suspension, suspension and oral solution are not in the list, which means that CFDA has actually deleted the list of base drugs For these 292 After the first one passed the consistency evaluation, three years later, it will no longer accept the application for the consistency evaluation of the same variety from other drug manufacturers It is reiterated once again that since the first one passed the consistency evaluation, the consistency of the same variety from other drug manufacturers should be completed within three years in principle The "three-year" period for the evaluation As the evaluation object has made it clear that the imported generic drugs and the original research drugs are also involved in the localization, which means that the manufacturers with imported generic drugs and the original research drugs in the current competitive products should start to actively layout the consistency evaluation, because the conservative estimation requires that all the tests of the consistency evaluation can be completed as soon as 15 months 3 The methodology and process of consistency evaluation have been basically determined The draft combines the guiding principles for selection and determination of reference preparations of general oral solid preparations (2016 No 61) and the procedures for consistency evaluation of quality and efficacy of generic drugs (Draft for consultation) issued by CFDA recently 》The selection and determination of reference preparation, research content of consistency evaluation, procedure of consistency evaluation, recheck, inspection and verification of consistency evaluation, safeguard measures of consistency evaluation, methodology and process of consistency evaluation are summarized However, some details, such as the catalogue of reference preparations corresponding to specific products, and the catalogue of varieties that can be used for consistency evaluation by in vitro dissolution test in accordance with the guiding principles of human bioequivalence exemption, have not been published This means that enterprises have to "feel the stones and cross the river" to explore by themselves The opinions of the general office of the State Council on the evaluation of the consistency of quality and efficacy of generic drugs (Draft for comments) on which varieties of competition to upgrade is more a summary of the currently issued rules The evaluation object clearly includes the imported generic drugs and the local varieties of the original research drugs, which means the competition of the chemical drugs is upgraded 292 basic drug catalogue varieties, the original research drug real estate varieties, the generic drug varieties listed in Europe, the United States, Japan and China by domestic and foreign manufacturers at the same time, the manufacturers of the three kinds of varieties will start to race with time This competitive process is full of risks and opportunities The risk is mainly manifested in the uncertainty of the selection of reference reagents and the lack of clinical resources The opportunity is that the earlier the manufacturer is evaluated, the better the manufacturer can enjoy the policy benefits of market monopoly It is expected that shuffling will mainly occur in the above three types of varieties and more manufacturers.