Can the original research and localized drugs really be used as reference preparations?

The consistency evaluation of generic drugs has been officially carried out for one and a half years The guiding principles for selection of reference drugs have been changed several times, and the final decision has been made so far It is needless to say that the enterprise is suffering It can be seen that the author's article "half of the competition has passed, but the end point is not in the front (evaluation of generic drugs consistency)" In this paper, the reference status changes of the original research and development of local drugs are analyzed In November 2015, CFDA issued opinions on the guidelines for the selection and determination of reference preparations for common oral solid preparations The principles are as follows: the imported drugs in the original research are superior to the imported drugs in the original research (hereinafter referred to as ">"), the local drugs in the original research, the superior drugs in the original research in foreign countries (Europe and America), and the internationally recognized drugs of the same kind The original localized drug obtained the second place status, but the good times were not long In March 2016, the official draft of guiding principles for selection and determination of reference preparations for general oral solid preparations was released, which changed the corresponding statement: "if the original research enterprise can prove that its localized drug is consistent with the original research drug, the localized drug can also be used as a reference preparation." In light of this, the laurel of the original research and development of local medicine will be taken off, so that its self-evident innocence At the beginning, many domestic and foreign-funded enterprises were optimistic, but then the development of the situation made the original research and development of self certification clear, and the hope of becoming a reference preparation was increasingly slim If you want to prove that "I am I", the difficulty coefficient is not generally large Subsequently, on May 26, CFDA issued a notice on the implementation of the opinions of the general office of the State Council on the evaluation of the consistency of quality and efficacy of generic drugs, which clearly pointed out that the generic drugs approved for listing before the implementation of the new registration classification of chemical drugs, including domestic generic drugs, imported generic drugs and the original research drugs, must carry out the consistency evaluation In order to get rid of the original drugs, we must carry out consistency evaluation, let alone as a reference But almost at the same time (2016.05.19) CFDA issued another document, which brought a ray of light to the original research and development In the "procedures for filing and recommendation of reference preparations for quality and efficacy consistency evaluation of generic drugs" The process and requirements for the application of reference preparation for the original research-based and localized drugs are specified in the document of, but in the second part of the application materials, it is obvious that "application materials for conformity assessment (refer to the requirements for application materials for conformity assessment of quality and efficacy of generic drugs)" The question of burning brain is whether to apply for reference or to apply for conformity assessment, haha No matter what, the domestic generic drugs can't rely on the local varieties for reference Who knows if you can declare through the reference preparations? Maybe you won't declare after the pressure, or maybe you deliberately have to wait until the end of the 2018 deadline to declare, and don't give other enterprises the chance to copy easily So we see that few domestic enterprises choose the local varieties in the reference preparations filing Who chooses who is stupid A dramatic scene has come A few days ago (June 9, 2017), CFDA released the announcement on issues related to the conformity evaluation of quality and efficacy of generic drugs (Draft for comments) The order of selection is: import of original research drug > original research and localization drug > non import of original research drug > drug with reference preparation status In the past 30 years, Hedong and 30hexi have returned to the status of the former research and development of local chemicals as the second reference preparation Salted fish turn over, runner up comes back, but how to make people chase it, how to imitate it as an idol (Reference)? Hard! Don't say that when the enterprise's reference was filed, it didn't select the original research and development products, or even the national designated reference catalogue I checked them one by one No reference preparation of 228 varieties is the designated original research and development products Don't believe it? You can check it in the generic reference preparation catalogue database of the pharmaceutical intelligence network Moreover, the three batches of original research and import reference preparations purchased by many enterprises have been in place or on the way In fact, I am not opposed to the original research and development of real estate varieties for reference, but now, once the draft for comments is corrected, the original research and development of real estate varieties manufacturers will be cheered, but the situation of domestic enterprises is very embarrassing On the one hand, competitors directly use the status of reference preparations to promote, on the other hand, generic drugs are difficult to enjoy the convenience of the original research and development of real estate varieties as reference preparations Sad! The author of this article recommends that: the competition is more than half, but the end point is not in the front (evaluation of the consistency of generic drugs) Case study on the selection of reference preparations Big talk: systematic screening and scientific analysis of pre-determined drug varieties for the adjustment of medical insurance drug catalogue in the brief history of China's medicine division Information acquisition and utilization of 10-year Memorial generic drug research and development in 2006 drug registration and verification Tragedy (2) Under the new policy of drug registration, where to go from the original statement: This article is the original contribution of yaozhi.com, welcome to reprint, reprint please indicate the source and author, thank you!