the system of licensing holders of drugs is expected to push researchers and institutions across the country to apply for registered drugs
author：anhua groupbrowse：18619
only drug manufacturers can apply for registration of drugs for a long time. drug research and development agencies and researchers can apply for registration of drugs and entrust enterprises to produce them. the pilot project to encourage drug innovation will be pushed back across the country in the future. before the relevant person in charge of national food administration of drug safety in the first drug policy and industry innovation and development on the bbs, since 2016, china formally started drug marketing authorisation holder system since the pilot, as of october 2017, pilot areas had dealt with 560 pilot drug varieties of all kinds of application, research institutions contribute quite a lot. the bbs is hosted by the china medical news information association and china medical city.
at present, china is fully revising the drug administration law. "the biggest bright spot is the introduction of a comprehensive licensing system for drug listing." liu pei, inspector of the legal affairs department of the food and drug administration, said on bbs.
1. saving the cost of drug innovation
according to china's current drug administration law, only drug manufacturers can apply for registration of drugs. under the management system of the product registration and production license, the researchers and institutions must first have the production conditions, i.e. this not only increases the cost of drug development, but also leads to duplication.
, by contrast, under the system of pharmaceutical marketing authorisation holder, drug marketing authorization and are separate from the production license, pharmaceutical research institutions and scientific research personnel can apply for registration and keep drug approval number (namely become drug marketing authorisation holder), to set up a drug production enterprise, or entrust other enterprise production. construction of a drug production line needs to be poured into hundreds of millions of yuan, and the cost of construction can be saved by the entrusted processing. the research institutions that do not have the production conditions can be exempted from the huge cost of the factory.
in june 2016, the general office of the state council issued a notice on the pilot scheme for the licensing of pharmaceutical listed drugs to be issued and launched in 10 provinces, including beijing, guangdong and shandong. "the pilot work has achieved initial results." as of october 2017, a total of 560 applications of various types of applications have been accepted by the pilot provinces, and 128 of them have been completed, according to yu huan, director of the pharmaceutical division of the administration of food and drug administration. the pilot work has saved the cost of drug innovation, shortened the market period of the drug, and increased the expected benefit of scientific research. and marketing authorisation holder is responsible for drug production and sales of the chain and the whole life cycle management, the drug preclinical research, clinical trials, manufacturing, distribution and distribution, adverse reactions monitoring take full legal responsibility, is more advantageous to implement the main responsibility.
"the product that has been approved by the listed licensee has saved tens of billions of yuan." mr sun, vice minister of food drug safety administration recently in the 2017 china (lianyungang) international medical technology conference, marketing authorisation holder system, will promote the development of three kinds of medicine mode: one is the research and development, production and sales; second, the research focuses on the study of not producing; three is lack of research ability, only do commission processing.
2. obligations cannot be transferred at will
however, some problems were found during the trial.
in accordance with the regulations, the holder shall bear primary responsibility for the quality of the drug in its entire life cycle. "production can entrust, but cannot be entrusted responsibility, we hope that the holder of the product life cycle has certain management ability, such as quality control ability, adverse drug reactions monitoring ability, etc., to establish drug quality assurance system, rather than rely solely on the entrusted production." mr. liu said that the quality agreement between the holder and the entrusted production and management company needs to be standardized and some obligations cannot be transferred at will.
chen yongfa, a professor at china pharmaceutical university, points out that, in the current pilot work, enthusiasm has not been sufficiently aroused despite enthusiasm among researchers. "to be a holder, a scientific institution needs not only a lot of money, but also a management team that runs through the life cycle and takes on the risk, which is a big challenge."
some holders do not have the experience of drug production management, and may lack the responsibility consciousness and ability to guide and supervise the drug production process. moreover, if the communication between the holder and the agent is not smooth, the quality responsibility of the entrusted manufacturer will be reduced, and the risk of violation will be increased. "the us food and drug administration (fda) has examined data from 154 factories and found that the quality risk of the consignment is significantly higher than that of the owners themselves." "chen yongfa said.
in addition, the problem of intellectual property protection in commissioned production should also be taken seriously. chen yongfa points out that the intellectual property between the holder and the trustee is unclear, which can easily lead to disputes over intellectual property rights. the trustee may engage in similar research with the intellectual property and trade secrets he has acquired from the entrusted project. the lack of internal management capability may result in the disclosure of intellectual property of the client.
experience will rise to law
the pilot is to identify problems and solve problems. in august, the drug safety administration, the pilot provinces and cities to articles for further exploring the holder of the rights and obligations and legal liability, commissioned in the production of quality management system and production and sales of the whole chain of responsibility system, etc.
at the same time, a number of successful experiences have been explored in the pilot area. for example, jiangsu, shandong, fujian and other construction supply and demand information platform, promote the holder and the trustee exchanges and cooperation. guangdong will make innovative drug registration and the holder of the pilot seamless docking, including the green channel, the simultaneous completion of the declaration work.
the head of the food and drug administration, mr. bi jingquan, said recently that he hoped that the pilot provinces would quickly summarize the pilot experience and push for an early national push. in order to take the responsibility of the full life cycle of the listed licensee, revise the drug administration law and fix the experience in the form of laws and regulations.
yu huan, told reporters that they are working, summarize and foreign public license holder system research situation, formation of the pharmaceutical administration law "drug registration management measures for the amendments. at the same time, the relevant departments are also working on the formulation of the regulations on the management of drug listing licensee to form relevant management and technical guidelines.
marie, according to the revised the pharmaceutical administration law of the biggest bright spot is that from the past bundled products and enterprises, to manufacturing enterprises as the core management idea, to take the marketing authorisation holder system, separation of products and enterprises, products regulatory management concept.
"after the implementation of the newly revised drug administration law, the system of licensing holders of drugs may be completed in advance and will be fully implemented and will benefit the whole country." "chen yongfa said.
(chen haibo, journalist of guangming daily)