Medical net June 29 policy big break ice! The medical circulation is wide open, big company does not need to buy a merger, can directly layout the dot!
▍ policy let go: a library to set up the company
26, henan food drug administration website "henan province food and drug administration about reform and improve the pharmaceutical production circulation use policy to promote the healthy development of the pharmaceutical industry opinion" (drug safety and food medicine prison [2017] no. 131) (hereinafter referred to as "opinions"), is proposed for the first time in nationwide:
Allow qualified medicine group of companies in the establishment of the city to set up a wholly owned subsidiary company (unincorporated enterprises) pilot work, the drug management administrative licensing and drug quality management standard certification two check "unity", according to a application, merging, inspection, meet the requirements, at the same time to issue the pharmaceutical trade license, the pharmaceutical GSP certificate.
Improve the industry concentration degree is the purpose of this ice sexual policy, according to the file, the expression of "promote the transformation and upgrading of medicine circulation enterprises, speed up the formation of large-scale backbone enterprises as the main body, small and medium-sized enterprise for complementary medicine circulation network between urban and rural areas, promote the medicine circulation industry intensive, large-scale development".
So what kind of drug companies meet the conditions?
According to the opinion, two types of enterprises can enjoy this bonus first:
Total annual tax in 20 million yuan of above (including additional) or annual sales of 2 billion yuan of above, and in the past three years was not due to "callings, go vote" and business administrative penalties by the food and drug regulator, fake drugs is not government good faith enterprise "HeiBang" list of monomer pharmaceutical wholesale enterprises as a legal person of permitted in the establishment of the city to carry out the work (unincorporated enterprises) pilot set up wholly owned subsidiaries.
During the trial period, the number of enterprises that meet the above conditions shall apply for the establishment of a branch (non-legal enterprise) in principle no more than three.
"Although there are only three, but it is already a very good policy, to improve the industry concentration degree is very good, if can also according to this way to promote other regions, pull function on the development of the whole pharmaceutical industry will be very obvious." Yesterday, jiuzhou pharmaceutical group co., LTD., vice chairman of the board of directors in one million, Dr. Liu, an interview with the blue parker said the "let go" will greatly reduce the large pharmaceutical business at the grassroots the stationing of obstacles and cost, quickly open the market, is advantageous to the rapid increase of industry concentration.
He told the blue parker, according to the current policy, some big companies in the cities and counties have no outlets, wanted to do, go deep into the market under the business qualification will be necessary, but the threshold of the modern logistics is very high, and to cities and counties in the size of the market itself is not big, less likely, in accordance with the standards of modern logistics construction.
Is the acquisition of this case, the commonly used gimmick, for large companies, however, there is more than purchase to worry about the cost and the local enterprises with me - the company's past may hide compliance, such as financial risk, is likely to be a greater risk of uncertainty, and these tend to be the long distance running of large business are most concerned about.
In his view, the henan policy has broken the restrictions on the establishment of modern logistics, the conditions are relaxed, enterprises can set up their own companies, and reduce the risk of setting points everywhere.
In other words, if big commercial companies only need to set up branches to operate in different places:
1. Big business can expand rapidly, layout network, achieve the concentration degree greatly increase;
2, to the local business form a huge impact, can quickly eliminate a large number of small and medium-sized businesses, pharmaceutical trading license due to restricted access "shell resource" value will have fallen sharply, completely worthless.
3. For the implementation of the two-ticket policy, it has brought great convenience to big business enterprises. The implementation of the two-ticket system requires a rapid expansion of coverage, which can be implemented through the establishment of branches, and the cost of entering a regional market is greatly reduced.
▍ big commercial expansion
In medicine circulation, deputy director of professional committee of Chinese society for the study of drug regulatory committee, national food drug safety administration expert professor WenXuMin's view, this time in henan "first" policy, is also true of large commercial expansion, mergers and reorganization encouraging policy file first landing place.
"Either in much starker choices-and graver consequences-in planning or 'the article 17, propel the development of the industry scale is an important content, but the specific policies, landing the henan version of the file is the first time." "He said to cypress blue.
Market analysis, also thinks the henan newly introduced the policy, will quickly "inspired" other provinces have issued try the new large commercial fall to the ground, and spread from one place of the open policy, the improvement of pharmaceutical business concentration effect is self-evident.
On the other hand, in the context of two voting systems, small and medium-sized businesses that have been struggling to survive will undoubtedly accelerate the process of merger and integration. Hold licences waiting for small businesses are beginning to lose opportunities, after all, have a library can set up a branch in the hands of big business, why spend money to buy the high compliance risk of small business?
The more powerful, the weak, the pharmaceutical business is polarized, perhaps sooner than we expect.
The attached:
The food and drug administration of henan province is concerned with reforming and improving drug production and circulation
Use policies to promote the healthy development of the pharmaceutical industry
Food and drug administration (2017) 131
The food and drug administration bureau of the food and drug administration of zhengzhou airport economic comprehensive experimental zone, which is the provincial municipality, the provincial government, and the municipal food and drug administration,
For the implementation of the general office of the state council on further reform and improve the pharmaceutical production circulation use policy several opinions (countries do hair [2017] no. 13) and the provincial government "to promote healthy development of the medicine industry in henan province implementation plan" (yu ZhengBan [2016] no. 220) spirit, promote "health central plains", "medicine strong province" construction into practice, we put forward the following opinions:
1. Significance
The pharmaceutical industry is the support the development of medical and health undertakings and the important basis of health services, will guide the whole construction machinery is strong growth, relevance and sunrise industry, in livelihood, steady growth has played an active role. Vigorously developing the pharmaceutical industry is of great significance to deepen the reform of the medical and health system, promote the healthy China construction, and cultivate the new impetus for economic development. In recent years, although the province pharmaceutical industry achieved rapid development, rapid growth of industrial scale, will markedly enhance its capability of supply, but still faces the independent innovation ability is not strong, well-known brand enterprise is not much, unreasonable industrial structure, the problems such as nonstandard circulation. For this purpose, the provincial party committee and government put forward health zhongyuan construction and improve the food and drug safety system, vigorously promote the reform of supply side structural, the implementation of the pharmaceutical industry's four big development project, carry out four big promotion action, speed up the implementation by the medicine to medicine strong province of guangdong province. The provincial food and drug supervision and administration departments at all levels must seize the favorable factors and opportunities, earnestly implement the provincial party committee, the provincial government to deploy, through and decentralization driven by innovation, optimize the industrial structure, cultivate brand and stronger varieties, increase the degree of intensive, speed up the formation with large backbone enterprises as the main body, small and medium-sized enterprises for complementary medicine circulation network, urban and rural areas to do big business scale, foster a batch of our province competitive large enterprise groups nationwide.
Basic principles
(1) reform led and innovation-driven. We will vigorously promote supply-side structural reform, get rid of the path of following development, focus on original innovation and innovative service mechanisms, and support innovation in scientific and technological innovation, business model innovation and operation and management mode.
(2) security for this and coordinated development. Resolutely implement the "four most strict" requirement, strengthen enterprise quality of main body responsibility, improve the quality standard and testing system, keep not systematic, regional drug safety problems of the bottom line, promote balanced development among pharmaceutical production enterprise.
(3) active service and efficiency are preferred. Deepening the reform of and on power, as well as the combination of the pipes, optimization services, reduce the examination and approval in advance, improve the matter later regulation, the regulatory center of gravity down, take the initiative to solve the contradiction of the issues hampering the new kinetic energy release, provide more convenient and efficient service, better play a regulatory role in the new kinetic energy.
(4) market dominance and policy guidance. Strengthen the dominant position of enterprise market and give play to the decisive role of market in resource allocation. We will improve the industrial policy and regulatory system. We will standardize market order, guide enterprises to optimize their varieties, expand service areas, improve industrial concentration, and promote industrial transformation and upgrading.
Specific measures
(a) to standardize the threshold of entry in accordance with the law, reduce the cost of institutional transaction and create favorable benefits
The policy environment for entrepreneurship. It is necessary to remove the policy restrictions that impede the development of pharmaceutical production and business enterprises according to law, and eliminate all kinds of preconditions and hidden barriers (including retail) that are not legally based. We will further build an open and fair market environment conducive to entrepreneurship, optimize services, unify the examination and approval standards, optimize the approval procedures, standardize the approval process, and promote employment and entrepreneurship. It is strictly forbidden to set administrative license and increase the conditions and procedures for administrative licensing.
We will improve the industrial structure and improve the structural adjustment of medical products. Vigorously promote the leading enterprises in our province cross-industry, interdisciplinary merger and reorganization and support medicine and chemical industry, medicines and proprietary Chinese medicine, drug substances and drug products, combination of production and circulation enterprises, thus forming the integration of upstream and downstream enterprise group, really solve the problem of small, scattered and disorderly.
(3) import and export of service drugs. To simplify the issuance of "certificate of export of raw materials" and "certificate of pharmaceutical sales". To guide enterprises implement GMP transformation, the service preparation production enterprises in our province to apply for European directorate for the quality of medicine issued (EDQM), American FDA certification, and the world health organization (WHO) certification, provide relevant laws and regulations, technical advisory services, strengthen collaboration with international review team, strive to make better industrial base in our province, on advantage of complete quality assurance system enterprise passes to enter the international medical market, into the international high-end market, become the international drug procurement suppliers, and promote our province pharmaceutical production quality control system in line with international standards.
(iv) simplify the application for registration of drugs. New drugs, generic drugs, and drug registration address change production, enterprises apply for registration production site inspection, may apply for the GMP certification, registration production site inspection with GMP certification site inspection at the same time. After obtaining the approval document of the drug, the enterprise shall issue the drug GMP certificate.
(v) speeding up the approval procedures for drug technology transfer. Improve the approval process of technology transfer variety, make the three links of technical review, site inspection and sample inspection seamless, compress and approve the time, and improve work efficiency.
(6) protect intellectual property rights of good enterprises. Enterprise in the process of rebuilding expansion, such as reform, can be retained in accordance with the pharmaceutical production license and the corresponding production scope and registration approval number again on time, avoid enterprise resulted from drug approval document for technical reformation.
(7) carry out pilot experiments on the scientific research of Chinese medicinal granule. In conjunction with the provincial ministry committee, provincial bureau of traditional Chinese medicine and other departments, merit-based research base and production conditions of unit, promote traditional Chinese medicine formula particles of scientific research and technological upgrading, production technology research and clinical efficacy of contrast research.
(8) support the development of the whole industrial chain of medicinal materials in the production. To revise the standard of Chinese medicinal materials in henan province and the processing standard of traditional Chinese medicine, to meet the requirements of production and clinical use. Standard Chinese herbal medicine, Chinese medicine yinpian circulation of production quality management, support the four huaiqing Chinese medicines, dogwood, dong ling grass, forsythia, honeysuckle, yu salvia miltiorrhiza and radix bupleuri, gardenia, yu a. dahurica, magnolia flower, eucommia bark, standardization of medicinal materials deep processing, enhance brand competitiveness of yu, medicinal materials.
(9) to simplify the start-up procedures of Chinese traditional Chinese medicine. Will Chinese medicine yinpian administrative licensing and drug production quality management standard certification check twice "unity", an application, merge, meet the requirements of the "drug production quality management norms", at the same time to issue the pharmaceutical production license, the pharmaceutical GMP certificate.
(10) promoting the transformation and upgrading of drug distribution enterprises. Break the pharmaceutical products market segmentation, local protection, nurturing large-scale modern medicine circulation backbone enterprises, speed up the formation of large-scale backbone enterprises as the main body, small and medium-sized enterprise for complementary medicine circulation network between urban and rural areas, promote medicine circulation industry intensive, large-scale development. Encourage total annual tax in 20 million yuan of above (including additional) or annual sales of 2 billion yuan of above, and in the past three years was not due to "callings, go vote" and business administrative penalties by the food and drug regulator, fake drugs is not government good faith enterprise "HeiBang" list of monomer legal pharmaceutical wholesale enterprises, in the establishment of the city set up wholly owned subsidiary company (unincorporated enterprises) pilot work. During the trial period, the number of enterprises that meet the above conditions shall apply for the establishment of a branch (non-legal enterprise) in principle no more than three.
Apply for the establishment of a branch to meet the requirements of the pharmaceutical wholesale enterprises (unincorporated enterprises), should meet the national food and drug administration issued by the newly established drug wholesaler acceptance implementation standard, and conform to the requirements of the "drug-handling quality management norms", its business scope shall be within the business scope of the head company.
Approval to set up branch (unincorporated enterprises), take the drugs management administrative licensing and drug quality management standard certification two check "unity", according to a application, merging, inspection, meet the requirements, at the same time to issue the pharmaceutical trade license, the pharmaceutical GSP certificate.
A legal person's wholesale enterprise shall bear all the legal liabilities arising from its establishment of a branch. Wholesale enterprise set up by the non-legal-person branch, must be in accordance with the instructions of its wholesale enterprise headquarters in storage and distribution business, legal person can be integrated in drug storage and transportation system within the enterprise resources, realize the warehouse together, improve the efficiency of resource utilization, made solid progress "two votes". Legal person enterprise set up a branch, its daily supervision by local food and drug regulatory authority, the case across regions or the jurisdiction of the dispute, by the provincial food and drug administration in accordance with the designation of jurisdiction.
(11) encourage wholesale and retail chain enterprises to set up direct retail stores and operate wholesale and retail stores. We should speed up the approval process and increase the retail pharmacy chain rate. Pharmaceutical wholesale enterprises, retail chain enterprises set up a retail chain retail pharmacies, according to a application, merging, inspection, accord with the pharmaceutical retail enterprises quality management standard "requirement, at the same time to issue the pharmaceutical trade license, the pharmaceutical GSP certificate. We will encourage municipalities and provincial-level cities to carry out pilot programs for classified management of retail pharmacies.
(12) actively promote the "Internet + drug circulation". In order to satisfy the demands of the crowd safety and convenient medication as the center, positive play "Internet + medicine circulation" in reducing transaction costs, improve the efficiency of circulation, and promote information disclosure, to break the monopoly advantage and function. We will guide the development of the "Internet + drug distribution" standard, support the cooperation between drug distribution enterprises and Internet enterprises, promote the integration and development of online and offline, and cultivate the emerging industries. We will standardize the online retail services of retail pharmacies, promote new distribution methods such as "Internet booking" and "online booking". We will encourage qualified regions to rely on existing information systems to carry out drug administration services such as online prescription review and rational use of medicines.
Strengthen the construction of credit system. Integration of the existing credit information resources, the establishment of pharmaceutical production enterprise credit records, into the state's unified exchange of credit information sharing platform, and in a timely manner in accordance with the relevant regulations in the "credit" henan public website.
Relevant requirements
The food and drug supervision and administration departments at all levels should further raise awareness, firmly grasp the "strict character overhead" objective law of the food and drug supervision work, follow the basic requirement of "the four most strict", take "source fight with sympathetic, risk control, process" regulation, "yan from farmland to dining table, every line of defense from the lab to the hospital, let the safety of the people to eat, eat the rest assured". Continue to strengthen the regulation of pharmaceutical production quality and safety, supervise and urge enterprise strict drug production quality management standard, faithfully record the production process of all kinds of information, to ensure that the data are true, complete, accurate and traceable. Continue to strengthen the drug distribution order regulation, supervision and quality control standard for pharmaceutical management and heavy punishment on loan business licenses, false trading, forge the record selling drugs, illegal channels and forge, falsely making out the invoice, such as violation behavior, a crackdown on doping ShiJia illegal crime molecules, the production and sale of counterfeit goods, to ensure drug quality and safety.
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