echemi logo
Product
  • Product
  • Supplier
  • Inquiry
    Home > Active Ingredient News > Drugs Articles > How to evaluate the consistency of domestic endemic varieties?

    How to evaluate the consistency of domestic endemic varieties?

    • Last Update: 2018-04-26
    • Source: Internet
    • Author: User
    Search more information of high quality chemicals, good prices and reliable suppliers, visit www.echemi.com
    Source: a batch of products have passed the evaluation one after another after the launch of the starting gun of the overall competition for the consistency evaluation of the pharmaceutical economic news on April 26, 2017, and the quick report is out At the national drug Fair held in Shanghai some time ago, these varieties were also hot Enterprises invested human and financial resources to carry out consistency evaluation, and its market prospect is self-evident In addition, the "opinions on reform and improvement of supply guarantee and use policy of generic drugs" also reiterated the firm confidence of upgrading and encouraging domestic generic drugs, so as to implement the product follow-up landing policy after the consistency evaluation All institutions are required to support excellent generic drugs in purchasing, medical insurance, tax, publicity and other aspects, replace the original research, implement the prescription review system, and hold accountable for the excessive use of imported original research through consistency evaluation of products At this point, if there is still a fluke mentality in the industry to wait and see, do not leave the illusion of relaxation, we must be down-to-earth What market opportunities can mining market opportunities and business value bring to enterprises through consistency evaluation? How much business value is created? It can be considered that the relevant products of the enterprise can take the lead in the registration application first through the consistency evaluation The second is to solve the historical problems of varieties (such as completely changing the inconsistency between the prescription process and the registration process) The third is to take the lead in reflecting the "high quality" of varieties through consistency evaluation, and then realize the "high price" and reshape the market pattern Fourth, to achieve differentiation and stand out in the competition Fifth, the relevant products can be changed into holders through MAH system, master the initiative and realize their commercial value In this paper, the author wants to talk about some "unique varieties" of "domestic unique products" Most of the domestic unique varieties are of long history, low price and low profit margin For example, berberine hydrochloride is only a few yuan for 100 tablets Enterprises do not pay for it to promote the quality improvement They call on the state to implement the incentive policy as soon as possible, so that it can have a price protection after passing Because the price is too low to reflect the dignity of producers, we should ensure that such classic drugs with clinical value can serve the clinical better There are many unique products in China, at least including: berberine hydrochloride tablets, piperazine ferulate, compound aluminum hydroxide tablets, biphenyl diester tablets, compound reserpine tablets, racemic anisodamine tablets, nystatin tablets, Compound Glycyrrhiza tablets, lactase tablets, thyroid tablets, biphenyl diester dropping pills, nilestriol tablets, huperzine A tablets and capsules, buguizine hydrochloride tablets, anisodamine hydrobromide tablets Compound medroxyprogesterone acetate tablets, compound reserpine and triamterene tablets, compound naphthoquine phosphate tablets, etc Among them, there are many drugs with remarkable curative effect, which can even be called classic drugs, which are not available in foreign countries, so consistency evaluation should also be done We have always been concerned about how to evaluate the consistency of domestic unique varieties In fact, CDE has specific regulations: enterprises can choose to carry out clinical trials again to prove its safety and effectiveness, and submit applications in accordance with the requirements for application materials for consistency evaluation of quality and efficacy of chemical generic oral solid preparations (Trial), which will be deemed to pass the consistency evaluation after the follow-up review; if enterprises do not choose to carry out clinical trials again, the national competent department shall carry out the external evaluation It is not recommended to use because of the lack of effective data The second development should be referred to in the consistency evaluation of special varieties Based on the work experience of my company, there is the following information sharing about how to carry out the pharmaceutical research on the consistency evaluation of "unique varieties" - that is, we should re study according to the thought of "secondary development" and the requirements of ICH, including but not limited to the number of synthesis process, quality control, impurity and miscellaneous mass spectrometry analysis studies According to, production process control, risk control and strategy, reanalysis and evaluation of preparation process procedures, etc More specifically, due to various historical reasons, there are more or less defects in the process, prescription, standard, stability and other aspects of the pharmaceutical research of unique varieties in China For example, the content determination method in the standard is too old, the sensitivity or patent attribute is not strong, at that time, HPLC has not been widely used in quality control, and the qualitative thin-layer method is still used for the relevant material methods In addition, due to the insensitivity of the test method, the relevant substances are not fully exposed and need to be re combed According to the principle that quality comes from design, my team reshaped and annotated the process research, production, quality management, risk control, safety and effectiveness of drugs In most cases, the process and prescription may need to be changed In this paper, the research of pharmaceutical consistency (CMC) is summarized as the following (including but not limited to) content presentation (as shown in the table) Table: the research content of pharmaceutical consistency (CMC part) in the consistency evaluation provides the symptomatic medical data meeting the requirements of ICH related guidelines According to the author's understanding, there are many kinds of unique clinical research data in China that do not meet the requirements of GCP and data management standardization in a strict sense, but it does not mean that there is no clinical efficacy In the current environment where the national requirements for data standardization are greatly improved, we must provide an acceptable evidence chain In view of this, clinical design should be carried out in accordance with the existing technical review requirements and various technical guidelines Inspection and inspection should be arranged Statistical analysis should be carried out in accordance with statistical principles and rigorous clinical reports should be provided In the case of conclusion support, approval of conformity evaluation should be applied Many of our country's unique varieties are declared before the new drug registration and evaluation system, and some are even early approved local standards In the process of upgrading the local standards later, there is still not enough pharmaceutical research and clinical research There are also some clinical reports or empirical clinical literature after being put on the market, but there are also studies without standard design, supervision, statistics, inspection and other GCP requirements, which can not be fully accepted and can only be used as a reference Therefore, these missing data need to be supplemented in order to enter the Chinese drug catalog In addition, we should also pay attention to: pharmacology and toxicology, drug metabolism and interaction, whether the research evidence is scientific, complete and standardized? If the evidence chain is incomplete, additional research is needed If necessary, the research on toxicology, drug metabolism, toxicokinetics and drug interaction should be completed again Summary as long as the clinical efficacy of the relevant varieties is accurate and the safety is guaranteed, we believe that the input-output will be rewarded by the corresponding market after the consistency evaluation or the enterprise actively applies for the reference preparation.
    This article is an English version of an article which is originally in the Chinese language on echemi.com and is provided for information purposes only. This website makes no representation or warranty of any kind, either expressed or implied, as to the accuracy, completeness ownership or reliability of the article or any translations thereof. If you have any concerns or complaints relating to the article, please send an email, providing a detailed description of the concern or complaint, to service@echemi.com. A staff member will contact you within 5 working days. Once verified, infringing content will be removed immediately.

    Contact Us

    The source of this page with content of products and services is from Internet, which doesn't represent ECHEMI's opinion. If you have any queries, please write to service@echemi.com. It will be replied within 5 days.

    Moreover, if you find any instances of plagiarism from the page, please send email to service@echemi.com with relevant evidence.