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    Home > Active Ingredient News > Drugs Articles > Eight major problems in the industry, as the representatives of four provincial pharmaceutical enterprises see it

    Eight major problems in the industry, as the representatives of four provincial pharmaceutical enterprises see it

    • Last Update: 2019-02-18
    • Source: Internet
    • Author: User
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    Through grass-roots research, there are eight issues that are most concerned by enterprises, including bidding procurement, consistency evaluation, production process change, drug registration management, traditional Chinese medicine management, API, clinical use of drugs and drug circulation These eight issues are also the most influential and hot topics for enterprises in the past year 1 Bidding procurement in Liaoning: 1 Call for the cancellation of the secondary bargaining in the name of volume procurement from the national level 2 It is suggested that tablets, capsules and granules should be divided into three bidding groups, with the average of the lowest 5 provincial bidding prices as the reference price for price limit, not only the low price 3 When calculating the price limit in each province, multiple packages are only calculated by multiplying the minimum preparation by the package, instead of the difference between packages Chongqing: 1 The party and the government should deepen the medical reform and reduce the drug price The enterprise firmly supports the measures When designing at the top level, the enterprise should adopt the spiral decline plan, so that the original research enterprise has the power to participate in, so as to really play the role of reducing the original research price 2 Carry out multi-dimensional monitoring on the implementation of the first batch of national centralized purchase pilot, and do not rush to implement the second batch of centralized purchase until all kinds of problems in the implementation process have been effectively solved, so as to avoid the situation of similar consistency evaluation 289 catalog varieties whether to postpone or not, which will affect the credibility of the government 3 Small enterprises reduce the price of competitive drugs at the expense of quality Large enterprises refuse to "replace inferior ones with good ones" for the sake of brand protection Inferior ones expel good ones It is suggested that drug bidding should not be based on low prices only The state should establish a reasonable bidding and purchasing mechanism Before the negotiation, a reasonable price range should be established, and the price of low-priced drugs should not be reduced twice, so as to guide the bidding and purchasing of all regions Reasonable price to purchase drugs with high quality and good efficacy to meet the needs of the people Zhejiang: 1 During the pilot period of 4 + 7 drug centralized purchase, it is suggested that the state, provincial and municipal social security bureaus do not copy or expand the scope of the pilot 2 It is suggested that the bid winning price of centralized drug procurement in 4 + 7 pilot cities should not be linked in the whole country 3 Centralized drug procurement should adhere to the principle of "quality first, reasonable price", resolutely abandon single source procurement, only low price is the policy guidance 4.4 + 7 market price reference system does not consider the cost of consistency evaluation, environmental protection, labor and other costs, so it is suggested to increase the subsidy for consistency evaluation 5.4 + 7 market consumption is far greater than the current national purchase volume, while the drug purchase volume depends on the doctor's prescription and hospital purchase volume It is suggested to clarify the actual clinical consumption of each variety, as well as the payment issues, the measures for the agreed purchase volume not completed, and the jurisdiction issues for the later implementation of supervision 2 Consistency evaluation Guangdong: 1 The variety of the reference preparation has been published, and it is recommended to complete the product quality consistency evaluation within 5 years from the date of publication of the reference preparation 2 Most of the products approved by the state in the early stage belong to the improved imitation products, which belong to the "three changes" variety It is suggested to postpone the completion of such products to 2025 3 For the products that the state has not published the reference preparation, it is recommended that the state screen and publish the reference preparation as soon as possible, so that the enterprises can carry out the work purposefully, and reduce the losses caused by the wrong selection of the reference preparation; if the state has not specified the reference preparation variety, it indicates that the variety has been stopped production outside the country and is eliminated from the market, and it is suggested that the evaluation of product quality consistency should be exempted temporarily 4 It is suggested that the state should further expand the scope of be exemption for safe, reliable, effective and mature varieties, and timely publish the catalogue of be exemption varieties 5 For the consistency evaluation of local drug products, it is suggested to carry out the comparative study of key attributes of product quality with reference preparation, and consider the exemption of be Chongqing: the source of raw and auxiliary materials of consistency evaluation varieties is single, and new suppliers need to be reviewed and reported to the National Bureau again The approval speed is relatively slow In addition, environmental protection supervision is becoming more and more strict Many API plants are facing shutdown or relocation, and pharmaceutical companies cannot choose the second or third suppliers in time Even though the consistency evaluation is passed, the safety of supply is challenged Suggestion: for consistency evaluation varieties, supplier alternatives will continue to be put to the Provincial Bureau for approval, so as to speed up supplier alternatives Zhejiang: it is suggested that the scope of financial assistance for consistency evaluation should be extended to varieties other than essential drugs For those who take the lead in completing the consistency evaluation in Zhejiang Province, it is suggested to give financial subsidies to promote the province to take the lead in completing the "consistency evaluation" work 3 It is suggested that the state simplify the examination and approval procedures, decentralize the review rights and speed up the review Many products belong to long-term production, stable quality and exact curative effect The state can transfer the approval right of drug production process change to each provincial Bureau, and thoroughly solve this historical problem within a limited period of time 2 For the excipients that have been listed and used abroad but not registered in China, it is suggested that the state allow the enterprises to directly go through the filing procedures, so as to speed up the wide application of new excipients in China's pharmaceutical industry; for the excipients commonly used in domestic food and used in large quantities for both food and medicine, the safety of the product has been fully proved by practice, and it is suggested that the food grade excipients are allowed in the pharmaceutical production by laws and regulations It is applied in production Liaoning: 1 It is suggested that after the process information registration or registration number declaration, the historical origin of all kinds of changes will not be traced any more; for the research samples of process changes, pilot test samples can be used to reduce the cost of changes 2 The reference object of enterprise process check shall be defined as soon as possible For some old varieties declared before 2007, due to historical reasons, the registered process can not be clearly verified The comparison blueprint of various checks shall be clearly defined by the State Administration 3 It is suggested that the regulatory authorities, based on the principle of risk management, take different regulatory measures for the change of different categories according to the risks of drug dosage forms and categories, and retain the partial approval or filing authority of the Provincial Bureau 4 It is suggested that the state speed up the examination and approval of supplementary application, simplify the research content of change according to the efficacy and dosage form risk in the technical guidelines for the change of production process of listed chemicals, and encourage enterprises to make changes that are conducive to the improvement of product quality and the progress of science and technology 5 It is suggested to relax the restrictions on the change of the production process of Chinese patent medicine, issue rules more suitable for the enterprise and simplify the review process, and revise the long-term left over varieties in a unified way again, and formulate a unified revision policy 6 Clear change types and registration application requirements For key changes that need to be registered and approved, it is suggested to set a shorter period of feedback For non key changes, it is suggested to adopt the method of implied permission If there is no feedback within 30 days, it is deemed to agree to the change For minor changes that have no adverse impact on product quality after evaluation, it is suggested to inform the supervisor in the way of annual filing Manage the Department to speed up the progress of enterprise change or process improvement Chongqing: 1 In addition to 289 varieties of conformity evaluation, other varieties shall be registered and filed, and the registration and filing process shall be used as the supervision process 2 It is suggested to manage in different levels, simplify the process change process, and put the process registration of listed products in the Provincial Bureau, so as to speed up the process, reduce the pressure of CDE, and put the process problems on a virtuous cycle 3 If there is no clear reply within the reply time limit specified by the relevant national competent department for process change, it shall be deemed as the default consent 4 It is suggested that the measures for the administration of drug registration (Revised Version), the provisions for the administration of simplified registration and approval of drug production site change, and the guiding principles for the study of drug production site change should be promulgated and implemented as soon as possible; the category of drugs should be taken into account in the change of classification, and drugs with narrow therapeutic windows such as toxic drugs, limited drugs and anesthetics should be strictly controlled, Nutrition medicine and common Chinese medicine should be lenient 5 Discuss and issue the announcement on the verification of drug production process as soon as possible, refer to the injection process registration method, lock the actual production process of various varieties of the enterprise, register and put on record, as the basis of process inspection, promote the production compliance of the enterprise, and the regulatory authority can supervise in accordance with the law Zhejiang: 1 The approval authority for the change of raw and auxiliary materials, production site and process of conformity evaluation products should be clear in the country or province 2 The cancellation number of API is modeled on the DMF management It is suggested to clarify the ways and methods of synchronous association with the preparation when changes occur, to advocate grading filing, and to encourage the application of new technologies and materials 3 For the site change or capacity enlargement of the production enterprise, the registration shall be simplified when the process, equipment, standard and quality control system remain unchanged 4 Relevant issues on the change of traditional Chinese medicine technology 1) The change of production site requires a comprehensive comparative study of pharmacy before and after the change For traditional Chinese medicine varieties, it is difficult to evaluate the impact of the change due to its relatively complex material composition and low controllability of drug standards for some varieties; 2) It is suggested to treat the technical standards of Chinese patent medicine and Western medicine separately for the change of excipients For the old products that pass the safety evaluation, if they are widely used and the adverse reaction monitoring is concluded, it is suggested not to change the excipients 4 Drug administration Guangdong: 1 With China's accession to ICH, the requirements for drug research and development, production, quality and other aspects have been improved The original drug registration management measures need to be revised and updated in time to meet the development needs of the current drug industry 2 At present, the State Food and drug administration is paying more and more attention to the safety of drugs The state drug adverse reaction monitoring center has successively screened the over-the-counter drugs and interviewed the personnel of relevant pharmaceutical enterprises According to the document "sfjjbz [2012] No 137", it is suggested that the "one size fits all" should be implemented It should be based on the product prescription analysis, the actual situation of adverse reactions, pharmacological and toxicological experiments and other data , rigorous and based on the transformation Liaoning: 1 According to the regulations on the management of vaccine storage and transportation, overdue vaccines shall be registered and recycled by the county-level disease prevention and control institutions It is not allowed to return them to the production enterprises after expiration However, in order to avoid destruction of some disease control products, the distribution of vaccines shall be stopped one month before the expiration date of the products, and they shall be returned to the production enterprises, causing unnecessary waste 2 When returning goods, due to the failure of disease control to provide the temperature data of the whole process, or to provide the temperature data, but it does not meet the specification requirements, what will the manufacturer do? Enterprises are usually faced with destruction and bear a lot of responsibilities 3 The manufacturer is the final person responsible for the quality of vaccine products, but after the vaccine leaves the company and enters the CDC warehouse, the supervision of the enterprise is almost blank, and there is a quality risk in return and resale 4 There is no description of the regulations on the procurement of vaccines with short-term validity in the regulations: if some disease control personnel do not purchase vaccines with less than 6-month validity, on the one hand, it may lead to insufficient supply in the market, on the other hand, it is faced with a large number of products with short-term validity in stock that cannot be sold 5 It is suggested that the National Bureau should clarify the requirements for obtaining the registration number of APIs with the approval number as early as possible For APIs with the approval number, the approval number can be directly converted into the registration number before the re registration expires Before the National Bureau's policy is clear, the Provincial Bureau will continue to accept supplementary applications for registration such as address change, extension of validity period, etc 6 It is recommended to freeze the approval number of the unqualified re registration after it expires, and keep it for a period of time (such as 3-5 years) During this period, the enterprise can activate according to the needs, and then cancel the registration if it is not activated after the end of the transition period Features not produced for a long time
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