183 drug reviews cost up to tens of millions of dollars to develop.

▍ special writing / code Wanxuan according to incomplete statistics of the Medical Rubik's Cube, listed companies have announced the cost of research and development through the consistent evaluation of drugs (including the same pass) a total of 183.
, 67 costs were equal to or higher than $10 million.
24 of the 31 drugs passed in the same light were equal to or higher than $10 million.
without generic consistent evaluation, there would be no opening conditions for the chemical belt procurement mechanism, nor would it be able to maintain the smooth operation of the mechanism today and continue to expand in the future.
with the evaluation of enterprises, products increased, generic drug consistency evaluation work is entering the stage of accelerated development.
At the same time, after the third batch of national drug collection of the winning results, generic drug consistent evaluation of the corresponding research and development costs have become the focus of public opinion in the industry, exploring the industry, enterprises are looking forward to, willing to support the policy of support, supervision means, is an important issue that can not be avoided at present.
This paper will try to start from the recently obtained statistics on the cost of research and development of generic drug consistency evaluation, explore the promotion rhythm of enhancing the consistency evaluation of generic drugs from the aspects of comprehensive financial subsidies, medical reform linkage measures, work supervision and evaluation, and also talk about some specific implementation methods and details.
1, consistency evaluation should be reasonable subsidies generic drug consistency evaluation of this work, basically, overall in the interests of the country and the people, is the economic cycle, stock reform in the pharmaceutical sub-sector of the play, basic work.
, then, the state finances do not have a reasonable subsidy mechanism directly corresponding to the consistency of generic drugs, where does it come from? First, from the big idea, since this need to be supported by the work is the stock reform, the source of financial resources from the tight days of the province, and strive for "cage for birds."
Second, from the point of view of the suitability of specific deployment, some local finance than the higher financial shortage of money, the need to pull up the financial resources allocation of the decision-making level;
third, in order to ensure the establishment of a stable and long-term mechanism, it is suggested that some regions or parks with reasonable conditions should take the lead in exploring adjustable, controllable, balanced and sustainable empirical methods, and then gradually promote replication.
In our view, the pharmaceutical province with the strength of the pharmaceutical industry has the financial support conditions, can support the combination of imitation, agree that generic consistent evaluation is also industrial innovation and progress, can timely from the existing support policies to obtain dividend repayment.
pharmaceutical park with pharmaceutical industry plans can maintain a moderate foresight, with limited financial subsidies and research and development project investment in a complex way to support enterprises, product incubation, catch up with technology trends, competition in response to market demand.
In view of the financial subsidies, fund investment and other resources have always been less than demand, we suggest that it is not appropriate to take the form of large-water flooding support, but should establish two procedures: first, by enterprises, products to apply to solve the problem of insufficient supply of support funds and resources, the survival of the fittest;
these procedures are necessarily highly socially identifiable and transparent.
2, consistency evaluation should be comprehensive medical reform to do vertical and horizontal comparison of generic drug consistency evaluation is one of the core work of the three medical joint reform, related enterprises, products have also been extremely direct and profound impact.
so-called vertical comparison, preferring to examine a product evaluation is the first imitation? What is the urgency and importance? The so-called horizontal comparison, preferring to examine a product evaluation is difficult to imitate? How economical and competitive is it? Businesses make the most important decisions.
e.g. whether in the country or a region, a park, in general, the first imitation of successful evaluation of drugs, relatively will be valued;
such as: the track height of the same enterprises, products should consider the cross-section, accept business reshuffle, complementary advantages, to avoid overcrowding.
the number of generics listed through consistent evaluation is increasing, and the procurement mechanism for drug belt volume is constantly carrying the purchase object.
from the momentum and ambition of the development of both, in the technology, economic performance and scope of comprehensive coverage is the inevitable goal.
reference to the basic drug catalog, medical insurance catalog access methods, consistent evaluation, volume procurement is also urgent to establish support enterprises, product catalog.
In our view, all over, each park of this kind of catalog will be highly linked, should also identify two dimensions: First, to look at the first imitation of the drug and the evaluation of generic drugs, government-led support funds should use drug economics as an evaluation comparison, should not be based on the concept of qualitative;
In short, all localities and parks not only have certain flexibility and decision-making power to determine their own financial subsidies and fund investment, but also need to protect fairness and liquidity for the whole industry and the whole market, which requires the relevant policies and cooperative operating departments to maintain tension, vigilance, strength and tension.
, we support not only technology incubation, catch-up, but also market order progress and balance.
3, consistency evaluation should be to a high level of high efficiency accurate observation consistency evaluation of research and development costs, we note several characteristics: First, the same period, different enterprises have a large difference in special costs, to Amosilin capsules, for example, Connbe (0.25g) evaluation announcement time November 12, 2018, cost 4 million yuan; Colum Pharmaceuticals (0.25g) review announcement date is December 13, 2018, the cost of 7.36 million yuan; The special expenses decreased over time, such as the drop of pyridine tablets from 9.02 million yuan (Chongqing Pharmaceutical Friends) to 4.99 million yuan (Pro Pharmaceuticals); Friends), and so on; third, the exclusive evaluation of enterprises, products, the special cost of huge differences, such as acetic acid Abitorn tablets (Hengrui Pharmaceuticals) special costs of 39.05 million yuan, hydrochloric acid parrositin tablets (Huahai Pharmaceuticals) special costs of 1.59 million yuan. The special cost of the Timishatan tablet (Shanghai Medicine) is 8.5 million yuan, and the special cost of the Catopri tablet (Modern Pharmaceuticals) is 4.85 million yuan.
Pharmaceutical companies or shrewd, reflected in two aspects: on the one hand, not because of industry public opinion said that the consistent evaluation of the temporary shortage of institutions, and for a while, consistently "Loyang paper expensive", in many product rules, after the evaluation of the product research and development costs significantly lower than the first evaluation, after the evaluation is more passive.
also appeared that many enterprises package a variety of several product rules for consistency evaluation, so that the total research and development costs of marginal efficiency increased.
the other hand, it is not certain that the above-mentioned research and development expenses published by enterprises and products are true and pure special expenditures.
the same period, different enterprises, the special costs of large differences, why? There should be a reasonable explanation.
the exclusive evaluation of enterprises, products, the special cost difference is huge, there must be a reasonable explanation.
reasonable explanation, support funds should only be graded and measured.
It needs to be clarified that the application process and results of financial subsidies reflect the nature of incentives, but the level of financial subsidies should generally not be higher than a certain proportion of consistent evaluation of research and development costs, with a government background of fund investment if limited to help enterprises, product consistency evaluation, should also adhere to this principle.
to avoid the inefficient use of special funds for financial subsidies and to stimulate enterprises to move.
Further consideration, some places and parks should also explore, while providing financial support, guide the helped enterprises, products through open tender, competitive consultation and other ways to select CRO services, the direct benefits are: improve cost efficiency, encourage CRO services, clinical trial institutions to be bigger and stronger.
to avoid resistance, it can be piloted throughout the region in exchange for industry compliance.
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