Generic upgrade ambition

Source: pharmaceutical economic news 2016-01-04 is the first year of the 13th five year plan, and 2016 is also the year when the consistency evaluation of quality and efficacy of generic drugs is implemented Industry insiders predict that under the promotion of a series of policies, a real shuffle of generic drugs industry may occur during the 13th five year plan period The situation is in full swing For the consistency evaluation of quality and efficacy of generic drugs in 2016, industry experts use one word to predict - in full swing The two documents of the competent authorities in November 2015 are the key In November 2015, CFDA successively issued the announcement on several policies for drug registration review and approval (No 230 in 2015) and the announcement on Seeking Opinions on the evaluation of quality and efficacy consistency of generic drugs (Draft for comments) (No 231 in 2015) No 230 document implemented the measures of generic drug consistency evaluation as the necessary basis for drug review, and the approval of bioequivalence test of generic drug was changed to record, while No 231 document provided the time node of generic drug consistency evaluation On December 23, 2015, CFDA held a symposium on the data verification of drug clinical trials, which reiterated that it was necessary to accelerate the promotion of the drug listing license holder system and the consistency evaluation of generic drugs What's more, the consistency evaluation of quality and efficacy of generic drugs has changed from emphasizing the consistency evaluation of dissolution curve in vitro to emphasizing the consistency evaluation of bioequivalence No 231 document proposes that in principle, enterprises should adopt the method of in vivo bioequivalence test (be) for evaluation; for varieties that adopt the method of in vitro dissolution test for evaluation, the method of be should be adopted for subsequent evaluation "In the context of the current strict examination of clinical trial data, there may be a low willingness of institutions with be research qualification to undertake." Some industry insiders remind us that there is not much time left for generic companies During the 13th Five Year Plan period, there may be a real reshuffle of the generic industry According to the time node given in the relevant documents, by the end of 2018, if the chemical generic oral solid preparation in the national essential drug catalog fails to pass the consistency evaluation, the approval number of the drug shall be cancelled; after the first product passes the consistency evaluation, the other products of the same type are in 3 If the drug approval number fails to pass the evaluation within the year, the drug approval number shall be cancelled; if the drug approval number fails to pass the evaluation at the expiration of the validity period, the drug approval number shall be cancelled "A good, scientific and practical top-level design is required for the successful implementation of generic drug conformity assessment." The CFDA will set up a generic consistency evaluation center next year, the source said According to the State Council's opinions on the reform of the review and approval system for pharmaceutical and medical devices, "those who pass the quality consistency evaluation are allowed to mark on the instructions and labels, and support in clinical application, bidding procurement, medical insurance reimbursement, etc." In other words, in the future, the drug with the same efficacy as the original research drug is expected to be approved to print an obvious mark on the outer package of the drug If it is added with the priority in the centralized purchase and clinical use of medical institutions, the appropriate support of the Ministry of human resources and social security in the aspect of medical insurance payment, and the Ministry of industry and information technology in the enterprise The support of technological transformation and consistency evaluation will drive the upgrading of generic drugs and fundamentally change the status quo of generic drugs industry The vision of going to the world is to ensure the safety and effectiveness of public drug use, improve the overall level of China's pharmaceutical industry, promote the adjustment and upgrading of the pharmaceutical economic structure, and improve the international competitiveness of the pharmaceutical industry through the evaluation of the quality and efficacy of generic drugs and the consistency of the original research drugs in accordance with the CFDA related documents According to the law of market competition, when a drug is faced with dozens or hundreds of imitations, it will often lead to vicious price war and further squeeze the profit space "It is a good choice to enter the international market on the premise of ensuring the quality of our own generic products has been improved." Market analysts point out that governments in Europe and the United States are now encouraging their citizens to use generic drugs In addition, in recent years, tens of billions of dollars worth of patent patents will expire, so there is a huge market space for generic drugs "We can learn from India's development experience and speed up the export of pharmaceutical products." According to pan Guangcheng, executive chairman of China Chemical Pharmaceutical Industry Association, enterprises should speed up the introduction and training of international talents, master the foreign legal and market environment, speed up the international registration and production management system certification, enrich product lines, and improve the added value of exported pharmaceutical products It is necessary to strengthen the brand publicity and promotion of pharmaceutical products in China and improve the awareness of users at home and abroad We should take advantage of the advantages of APIs in China, develop new preparation technologies, and strengthen the research and application of new preparation technologies such as sustained-release, controlled-release, transdermal absorption, mucosal drug delivery and targeted drug delivery Industry experts pointed out that if China's generic drugs want to enter the international market, they need to understand and follow the current laws and regulations and application procedures of generic drugs in various countries, prepare high-quality application materials, and more importantly, they must apply the drug research and development concept of quality derived from design, improve production and analysis technology, and improve quality Pan Guangcheng also reminded enterprises to take the initiative to adapt to the new situation of economic globalization, promote the mutual promotion of opening up at home and abroad, better integrate "import" and "go out" and improve the level of international cooperation He suggested that enterprises should focus on high-level international cooperation in the fields of pharmaceutical design, research and development, production, marketing and clinical trials, speed up the international registration of drugs and expand the export of products One belt, one road strategy should be combined to strengthen cooperation with the countries along the route "At the same time, enterprises should learn the legal knowledge in the field of international medicine, strengthen the compliance management of enterprises, avoid the legal risks of international exchanges, and improve the level of open economy of medicine and the international trade surplus."