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

Source: the consistency evaluation of generic drugs on Jun 19, 2017 has been officially carried out for one and a half years The guiding principles for the selection of reference preparations have changed several times, but they have not yet been finalized It is needless to say that the enterprise's troubles It can be seen that the author's article "the competition has passed half, but the end point is not in the front (evaluation of the consistency of generic drugs)" 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 ones (hereinafter referred to as ">"), the localized drugs in the original research, 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 dust directly, it is necessary to carry out consistency evaluation, let alone as a reference But almost at the same time (2016.05.19) CFDA issued one document after another, which brought a ray of light to the original research and development In the document "procedures for filing and recommendation of reference preparation for consistency evaluation of quality and efficacy of generic drugs", it clarified the process and requirements for the application of reference preparation for the original research and development of drugs, but in the second part of the application materials, it was clearly required to provide "application materials for consistency evaluation" (refer to the requirements of the application materials for the conformity evaluation of the quality and efficacy of generic drugs) ", here comes the question of brain burning Is this the application for reference or the application for the conformity evaluation, ha ha 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 at all, 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 Very few, 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), which has made significant changes in the selection of reference preparations, The order of selection was: import of original research drug > original research and localization drug > non import of original research drug > drug with reference preparation status 30 years of Hedong, 30 years of Hexi, the status of the original research and development of local chemicals as the second reference preparation has returned Salted fish turn over and the runner up comes back, but how to make people chase them? How to imitate them as idols? Hard! Don't say that when the enterprise's reference was filed, it didn't select the original R & D product, or even the national designated reference catalog I checked one by one No reference preparation of 228 products was the designated original R & D product, don't you believe it? You can check the catalog database of generic reference preparations on www.zhiyao.com 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 reference of the original R & D products, but at present, once the draft for comments is corrected, the original R & D products manufacturers will be happy, but the situation of domestic enterprises is very embarrassing On the one hand, competitors directly use the status of reference products to promote, on the other hand, generic drugs are difficult to enjoy the convenience of the original R & D products as reference products I'm sorry! To be careful