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New progress in generic drug consistency evaluation

Time:2020-09-16 16:00:17  Source:  Author:


 Recently, the centralized drug procurement platform of Yunnan Province issued a notice on the related matters of the original research drugs, reference preparations, generic drugs approved according to the new registration and classification of chemical drugs, and the online trading of generic drugs through consistency evaluation. The notice pointed out: according to the requirements of the letter on online trading of relevant drugs issued by Yunnan Medical Security Bureau, the drug trading system of Yunnan Province centralized drug purchasing platform will be officially opened from September 17, 2020, and medical institutions can purchase directly according to the online price or through negotiation.

From September 17, the online trading qualification of drugs with the same manufacturer, same generic name, same dosage form and same specification in the original trading system and "Kunming 2020 commonly used low price drugs in centralized price negotiation" will be suspended at the same time. If it coincides with the manufacturer's product specifications in "Kunming 2020 commonly used low-cost drugs for centralized price negotiation", the online connection shall be adjusted according to the principle of low price.
It is understood that the introduction of generic drug conformity evaluation ensures that the generic drug is consistent with the original research drug in quality and efficacy, and realizes mutual substitution with the original research drug in clinical practice, which is not only conducive to saving medical expenses, but also helps to improve the quality of generic drugs and the overall development level of the pharmaceutical industry in China, so as to ensure the safety and effectiveness of public drug use.
More than 5000 pharmaceutical factories in China, 99% of them are generic pharmaceutical enterprises, and the number of drug approval documents is up to 190000, and 95% of them are generic drugs. Most pharmaceutical enterprises in China are mainly generic drugs. In 2018, generic drugs accounted for 63% of the domestic market, and the rest were innovative drugs.
Since the document "opinions on the evaluation of quality and efficacy consistency of generic drugs" was issued in 2016, major generic pharmaceutical enterprises have responded positively. After several years of development, generic drug consistency evaluation has made some progress. 235 new batches of drugs in Yunnan have been evaluated and approved to be put on the Internet, which proves the new progress of generic drug consistency evaluation. In addition, according to the data, as of August 2020, 600 enterprises in China have actively participated in the evaluation, and a total of 533 varieties and 2319 drugs have been accepted.
With the continuous deepening of consistency evaluation, local development will face more fierce competition challenges, but also full of new opportunities to seize the market and force industrial transformation and upgrading. How to capture the development opportunities of local medicine under the current situation of consistency evaluation? There are suggestions in the industry that for areas with good enterprise foundation, enterprises can be encouraged to actively expand product lines, especially for varieties that are urgently needed in clinical practice and with large market, and support enterprises to develop high imitation, difficult to imitate and first generic drugs. Relying on local generic drug stock enterprises and introduced incremental enterprises, the imitation development of drugs with clinical urgent need, shortage of supply, exact curative effect and expiration of new patents can be carried out to improve patients Drug accessibility, enhance the competitiveness of enterprises, seize the new market.
For regions with insufficient supply of API and limited development of API industry, it is necessary to support cross regional API preparation integration industrial layout and help enterprises open import channels to ensure the supply of API for local generic pharmaceutical enterprises.
With the continuous deepening of conformity evaluation, the quality and efficacy of generic drugs in China have been greatly improved. At the same time, with the deepening of generic drug consistency evaluation, enterprises are also facing the situation of transformation and upgrading. If a large number of generic pharmaceutical enterprises can not survive through the development of generic drugs, this old forced the transformation of generic pharmaceutical enterprises, while promoting the survival of the fittest of Chinese pharmaceutical enterprises. At present, many pharmaceutical enterprises have been strengthening the research of new drugs in order to obtain more competitiveness. According to the industry, the future transformation of traditional pharmaceutical enterprises will be completed in recent years, and innovation or imitation will be a choice.

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