Re: perspective China
since 2007 focused on children's medicine, sunflower pharmaceutical industry has been working in the pediatric medicine market for nearly 10 years. Guan Yanbin, the chairman of the board, told the weekly news weekly: "the spring river water warm duck prophet, we are aware of the problem of children 'lack of medicine and medicine' and the safe medication."
according to Guan Yanbin, sunflower Pharmaceutical Group has 69 children's medicine, and the retail volume of children's medicine has exceeded 5 billion yuan in 2015. It has become a flag of the current domestic drug production enterprises.
despite this, sunflower pharmaceutical industry still feels the hardships of "tailor-made" drugs for children.
Guan Yanbin said that the main obstacles to research and development of children's drugs are clinical trials and research and development inputs. From clinical trials, there is almost no mother willing to let her children bear the risk of clinical trials, which is a difficult problem all over the world. From the point of view of R & D investment, although the use of drugs for children is also large, long and risky, the profit of children's medicine is much lower than that of adult medicine. For example, the annual sales of an adult drug may reach billions and hundreds of billions of years, but the annual sales of children's drugs are usually only one. Two hundred million, at most two or three billion, so the enthusiasm of enterprises to develop children's medicines is not high, and the manufacturers of children's medicines are few.
the investigation of the National Association of Commerce and Industry Association of Commerce and industry of the National Federation of industry and Commerce showed that only 10 of the more than 6000 pharmaceutical factories in the country were specialized in producing children's drugs, including the Beijing first pharmaceutical factory, the Tianjin children's pharmaceutical factory and the Harbin children's Pharmaceutical Factory Co., Ltd. In addition, there are only more than 30 enterprises in the pharmaceutical production department of children, such as sunflower pharmacy group, Guangzhou Baiyun Mountain pharmaceutical Limited by Share Ltd, Huabei pharmaceutical Limited by Share Ltd and so on, but the share of more than 90% of the medical market for children is occupied by a few foreign enterprises.
in terms of the market size of children's drugs, the market scale of Chinese children's drugs has risen from 38 billion 350 million yuan in 2011 to 52 billion 660 million yuan in 2014, and the compound growth rate reached 11.2%, but in general, only about 4% of the pharmaceutical market of about one trillion.
urgent policy to help
child drug development obviously needs more policy support.
retrospect the relevant policies and regulations of Chinese children's drug use since 2003, and the opinions on the protection of children's drug use in 2014 (hereinafter referred to as "opinion") can be called the first comprehensive guidance document in China. The opinion was jointly issued by the six ministries and commissions, such as the State Health Planning Commission and the national development and Reform Commission, and put forward specific requirements to encourage R & D innovation, speed up declaration and approval, ensure production supply, strengthen quality supervision and promote rational drug use. After the landing of
opinions, the change of tendering policy followed closely. In February 2015, the general office of the State Council issued the guidance on the improvement of the centralized procurement of drugs in public hospitals, and put forward the implementation of "non patent medicines for women and children, emergency (robbing) medicine, basic infusion, and small clinical dosage (the specific scope of the above drugs is determined by the provinces and municipalities) and the commonly used low-cost drugs. Centralized network, direct purchase by the hospital.
2016 January, approval of the policy adjustment. The review and approval center of the State Administration of food and Drug Administration issued the basic principles for the evaluation and approval of the priority review and approval of the clinical application for children in clinical urgent need for children, and put forward that the application for drug registration for preventing and controlling children's disease and having obvious clinical advantages can be accelerated and examined and approved.
in June this year, the office of the National Health Planning Commission jointly issued the first batch of "the first list of children's drugs to encourage R & D declaration", which was included in the list, and its R & D declaration was encouraged by the policy.
in the face of the continuous favorable policies, Guan Yanbin said his expectation is very simple: "our business is hoping that these good policies can be truly implemented. In recent years, a series of preferential policies have been introduced, but there are still some problems in the implementation of policies. From the enterprise level, the industrial impetus brought by the national policy has not yet been implemented, and it needs active action from all walks of life to work steadily together.
specific to the approval policy, Guan Yanbin, for example, some traditional Chinese medicine is very classic, also very good, but they often have a big problem, that is not good, children are not willing to eat. At the same time their drug is not very convenient, mainly powder, need to use water and after taking, such Chinese medicine children are not very good to accept, so parents often knead the child's nose to the mouth irrigation. For such traditional Chinese medicine, if we change its dosage form and taste through modern science and technology, such as turning them into jelly - like, soft sugar - like drugs, and making their taste into Strawberry - flavored, orange - flavored, the child's acceptance will be improved and the use will be more convenient. However, from the present point of view, the improved dosage form and change of taste under the premise of guaranteeing quality have been approved rapidly in the examination and approval policy, but it has not been really implemented in some places.
Fang Shuting, President of the Chinese Medicine Association, pointed out that children still need more policy support in R & D, transfer, production, use and sales, and the government should pay more attention to enterprises so that enterprises can more actively "Customize" drugs for children.
Wang Xiaoling said that at present, there are few manufacturers of children's drugs in our country, and the specifications and dosage forms for children's medicine are also relatively small. "We expect more policies to encourage children to have more specific drugs available and optional, and let our doctors worry no longer without 'weapons' and lack of' weapons'.