The medical network has been in the doldrums of the original new drug registration declaration on September 12, the first explosion of explosive growth. Yesterday, the provincial food and drug administration revealed that in 2016, 11 new drugs registered in our province were registered, and the first and generic drugs were equally divided into 13 varieties.
"This is a 'turning point', which marks the transformation of pharmaceutical research and development in our province from imitation and high imitation to the development of innovative drugs with independent intellectual property rights." Provincial food drug administration drug registry place pair place long yi said excitedly, "after a number of measures, good policies have crowded, the drug registration in our province to declare the low level repeated construction effectively."
It is reported that over the years, the new drug registration in our province has been stuck in the "poverty line", accounting for less than two percent, while generic drug declarations have been occupying an absolute position of 80 percent. The attack was heartening. In the new drug declaration, a new class of new drug registration record high, up to 8, "rice hematopoietic" and so on. The research and development of these new types of new drugs has the characteristics of independent innovation, which is the same level and even advanced in the developed countries.
In 2015, the state council issued the opinions on reforming the examination and approval system for pharmaceutical medical devices, which opened the curtain on drug approval and reform. At this point, drug approval standards have been improved, and generic drugs are approved to be used as reference agents to ensure that their quality and efficacy are consistent with those of the original drug. Clinical value - oriented drug innovation will be included in the priority examination and approval channel. This means that the threshold for generic drugs has risen sharply, while the original new drug is under the policy tilt, bathing in the sun.
A tsunami hit the pharmaceutical industry, and a big shuffle was on the CARDS. The company is keenly aware of the smell of smoke, and a number of voluntary withdrawal of generic drug registration applications. By the end of August, 352 drug Numbers had been abandoned in the province, accounting for 26.7 percent, mostly generic drugs.
In the city of guanggu, wuhan, it is more pleasant to encourage the development of new drugs. In July, wuhan east lake high-tech zone administrative committee issued the wuhan east lake new technology development zone management committee on support the implementation of the economic development of biological industry opinion ", many measures and promote the development of biological industry, including biomedical. An article about support for new drug research and development of "blockbuster" sparked enthusiastic responses, "according to biological products, chemical medicine, Chinese medicine and natural medicine category is different, to early to give rewards to r&d, up to 100 million yuan."
According to the head of a local pharmaceutical company, the implementation of a series of policies has greatly inspired the innovation and development of enterprises. The leading enterprises in the province have increased their r&d manpower, technology and resources, and the number of new products has increased. At the same time, it also actively connects with the international community, referring to the technical guidelines in developed countries such as the United States, the European Union and Japan, and thoroughly conducts research work. "The state council and the provincial government deployed start drug approval for examination and approval system reform, drug research and development in our province registered structure optimization, the new characteristics of high quality and innovation ability, to" spring "moment." Wen Yi said. (reporter cui yu, hu, correspondent sun Lin)
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