By 2021, a large number of drugs will be de-marketed

Common medicines have been withdrawn from the market, why? In 2020, the State Drug Administration has issued a number of drug de-marketing announcements, according to incomplete statistics, a total of 409 drugs have been withdrawn from the market, which is not short of a large number of commonly used drugs.
reasons for de-marketing can be divided into two categories: First, drugs due to serious adverse reactions, after evaluation of the risk is greater than the benefits, so exit from the market.
Generally speaking, has entered the hospital or retail terminal varieties, if due to adverse reactions to the market, the relevant departments will also require manufacturers to recall the corresponding time in the market circulation of drugs, the result is that the market can no longer buy this drug, the recent de-market phenolic tablets is a case.
2. Drug approval belongs to what we often call "zombie approval", enterprises after economic efficiency assessment, choose to take the initiative to write off the drug code, but there are still other enterprises in the market in the production of the variety, the public can still buy this medicine in hospitals or retail terminals.
this, there are pharmaceutical production officials said: for the self-deregistration of drug approval number of varieties, in the production, quality are normal, it belongs to qualified drugs.
as long as according to the instructions and shelf life to take no problem, but later the enterprise produced the variety, in the market can not buy.
To take nofluorosas capsules as an example, there are already 622 approvals because of the large number of alternatives and the low unit price of its own varieties, so the discontinuation of production by an enterprise will not affect the purchase and use of consumers.
, why on earth did the company choose to take the initiative to withdraw from the market? Is the registration fee higher? In this regard, we interviewed Shanxi Taihing Pharmaceutical Group Business School Dean Yu Guoqing, he said: approval registration fees are not the same everywhere, the southern market is different from the north, most of the south is free, the north costs vary, to Shanxi, for example, about a thousand.
, then, companies no longer retain more numbers, but the existing drug approvals have been written off what is the reason? There has to be talk of generic drug consistency evaluation.
it can be said that generic drug consistency evaluation accelerated the "zombie approval" of the withdrawal, the entire pharmaceutical industry large-scale approval write-off will also become inevitable, without evaluation on the stop procurement do not do a consistent evaluation line? Of course not.
know that China is a large generic drug country, the pharmaceutical market there are a large number of generic drugs.
statistics, more than 95 per cent of the approximately 170,000 drug approval numbers available are generics.
And generic drug consistency evaluation refers to the approved generic drugs have been approved for market in accordance with the principle of consistency with the quality and efficacy of the original drug, in stages of quality consistency evaluation, that is, generic drugs in terms of quality and efficacy to achieve the same level as the original drug.
for historical reasons, generics were not required when they first came on the market, but now there is a consistent evaluation by the relevant authorities for reasons that are responsible for public health.
process is as follows: In 2012, the State proposed a plan to conduct a consistent evaluation of generic drugs, calling for a comprehensive improvement in the quality of generic drugs, so that generics and original drugs to achieve the same therapeutic effect.
2016, the program was officially launched, with oral solids consistency evaluation taking the lead.
2020, the evaluation of injection consistency was officially launched, and the evaluation of consistency continued to be in-depth.
according to official website data, as of August 2020, 600 enterprises nationwide have actively participated in the evaluation, a total of 533 varieties, 2319 drugs were accepted.
, 134 generic drugs in Shandong in 2020 through consistent evaluation of the number of the forefront of the country.
, in the country's more than 20 provinces and cities, not consistent evaluation of the withdrawal of varieties has gradually become the norm.
industry insiders told us: there have been thousands of varieties because of the lack of evaluation was withdrawn from the network suspended procurement.
evaluation, not want to do can do, generic drug consistency evaluation, nor enterprises want to do can do.
the current situation is the domestic single variety of drugs consistent evaluation market quotation has reached 3 million to 6 million, for enterprises, the pressure is relatively large."
the head of the research and development department of the production enterprise told us.
that is to say, for a company with a large number of approvals in hand, the cost of consistency evaluation is enormous.
Many economic strength of enterprises in general, consistent evaluation work has become a level not past, especially in the hands of a large number of approval of large enterprises, each variety spent millions of cases, this cost is completely unable to bear, so many enterprises choose to economic benefits of the general varieties, simply write off the market.
, pharmaceutical companies take the initiative to write off drugs, it has become a common phenomenon in the industry.
not write off zombie varieties, equal to the end of life" in the past China's new drug approval or drug re-registration costs are very low, almost equivalent to no money, and now, in the context of the state to encourage enterprises to develop innovative drugs, specialty drugs, many drugs although approved in hand, but production has long been in a semi-discontinued or completely discontinued state.
", said the head of marketing for a listed pharmaceutical company.
In addition, the introduction of the new "Measures for the Administration of Drug Registration" in July 2020 has also led directly to the re-examination of its varieties, which include various cost factors, such as experts, government relations and so on.
" When a cost is in front of it, the economic benefits of many varieties will be re-considered, thus accelerating the homogenization, lack of competitiveness of old drugs out of the market.
" is a broken tail to live, take the initiative to write off, reduce the pressure on enterprises.
" So, with the implementation of the "Drug Registration Management Measures", the domestic stock of 168,000 drug batches in 2021 will usher in a big wave of Taobao, the vast majority of the approval in a zombie state or will be directly eliminated by enterprises.
, can't the approval in the hands of the enterprise be transferred? In this regard, there are pharmaceutical marketing people have told us: the reality of the level, the conditions and procedures of the transfer have not yet landed.
according to Article 78(3) of the Measures for the Administration of Drug Registration: If the holder transfers a change in the license for the listing of a drug, the holder shall declare it by means of a supplementary application and implement it after approval.
this requirement, companies can obtain medicines by purchasing a number to complement their product lines.
the present situation, in accordance with article 9 of the Administrative Licensing Act, the transfer of administrative licences is subject to statutory conditions and procedures.
therefore, the implementation of the drug market licensing system under the Drug Administration Act, statutory conditions and procedures are essential.
the general transfer of rights, administrative license is granted by the administrative organ to a specific relative, there are no conditions and procedures for the transfer, without the approval of the administrative organ transfer, the transfer can not be achieved.