Since the implementation of the new chemical registration classification reform, China has 539 chemical drug registration applications filed in accordance with the new registration classification, of which innovative drugs account for half of the country, with 291 registered applications, accounting for 53.99%. According to industry experts, this means that in recent years, under the guidance of the “global new” policy, the pattern of drug registration declarations based on10365-98-7 generic drug declarations has gradually been replaced by innovative drugs. This change stems from the “Chemical Registration Classification Reform Work Plan” promulgated last March. The relevant person in charge of the Pharmaceutical Registration Department of the State Food and Drug Administration said that the “program” will adjust the definition of new drugs from the “drugs not marketed in China” to “drugs not marketed in China and abroad”, although only The difference between words has brought about qualitative changes. “This shows that the new drugs that the public needs are not simple repetitions of existing drugs, but new drugs with the meaning of 'global newness'. Industry experts said that this is to encourage the industry to take the road of innovation and enhance the international competitiveness of Chinese pharmaceuticals; It is also to encourage medicines developed by foreign pharmaceutical companies to come to China as soon as possible, so that Chinese patients can use better updated medicines as soon as possible.
In 2016, the drug registration declaration structure was significantly optimized, and the pattern of generic drug declaration was reversed. Zhang Qing, director of the Drug Registration Office of the Shanghai Food and Drug Administration, said that six of the 15 drug listing license holders registered in Shanghai last year were “global new” innovative drugs. Dai Weimin, director of the Taizhou Medical City New Drug Application Service Center, said that after the reform, the number of generic drug declarations has decreased sharply, and the number of innovative drug declarations has gradually increased. Among the new clinical approvals in 2016, there were 11 new chemical drugs and 2 biological products, and the number of innovative drug applications increased by 6.5 times compared with the previous year.87199-18-6
The new policy of drug review and approval reform changed the ecology of pharmaceutical R&D. The research and development pattern from “China New” to “Global New” gradually formed, and a large number of innovative products continued to emerge. “After the registration classification reform concept is in line with international standards, the gold content of new drugs has increased significantly. The review and approval focus on the clinical value and application advantages of innovative drugs and improved new drugs, which is undoubtedly beneficial to enterprises that truly focus on R&D and quality. "The director of the regulations and registration department of Luye Pharmaceutical Group Co., Ltd. said by Chunna.220210-56-0
Compared with foreign countries, there is no small gap in the level of drug research and development in China. McKinsey & Co., Ltd. recently released "Building a Sustainable Chinese Medicine Innovation Ecosystem", showing that the world's innovative drug market is nearly 600 billion US dollars in 2015, but China's market is less than 10 billion US dollars, of which it was first acquired in China. The 19 innovative products listed in the batch contributed less than $500 million.
Innovative drugs are difficult to develop, and the new drug research cycle is long, the investment is large, and the risk is high. But in the long run, the research and development capabilities of innovative drugs are still the core competitiveness of enterprises. Ding Jian, an academician of the Chinese Academy of Engineering and director of the Academic Committee of the Shanghai Institute of Materia Medica of the Chinese Academy of Sciences, said in an interview with the reporter of the Economic Daily that it is vital that a new drug is not accessible to enterprises and scientists. A good policy environment is of paramount importance. In recent years, with the support of a series of policies on drug trial reform, new drug research and development has entered a new era, and innovative drugs are on the rise. I believe that the pattern of domestic innovative drugs will be greatly improved in the next few years.
Some pharmaceutical companies have suggested that they should speed up the reform of the drug review and approval system, further improve the evaluation criteria and technical guidelines, and study policies such as clinical trial management, data protection, and patent links to further encourage innovation, and create a favorable policy environment for drug R&D innovation. Let more innovations benefit the people.
Klinechem sets up 2000m2 R&D center in Shanghai city, and can provide customers with custom services of pharmaceutical intermediates from gram to kilogram scale. There is a production base in Coastal Industrial Park in Lianyungang City, and it was equipped with leading technologies and advanced equipment. Therefore, we are capable of all productions from small test, pilot production to industrial production; we are able to produce fine chemicals in ton level.
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