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    Home > Active Ingredient News > Drugs Articles > New progress has been made in the evaluation of generic drug consistency, and 235 new batches of drugs have been evaluated in Yunnan

    New progress has been made in the evaluation of generic drug consistency, and 235 new batches of drugs have been evaluated in Yunnan

    • Last Update: 2020-11-17
    • Source: Internet
    • Author: User
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    "Pharmaceutical Network Industry Dynamics" Recently, Yunnan Province's centralized drug procurement platform issued a notice on the original research drugs, evaluation preparations, according to the new registration of chemicals approved generic drugs and through the consistent evaluation of generic drug online transactions related matters. The
    notice states that, in accordance with the requirements of the Yunnan Provincial Medical Security Bureau's Letter on the Trading of Related Drugs, the drug trading system of the centralized procurement platform for drugs in Yunnan Province will be officially launched from September 17, 2020, and medical institutions may purchase directly at the list price or at bargaining prices.
    From September 17th, the original trading system and "Kunming City 2020 commonly used low-cost drugs in the centralized bargaining of selected drugs" with the project linked to the same manufacturers, the same generic name, the same dosage form, the same specifications of drugs on the network trading qualifications.
    and "Kunming City 2020 commonly used low-cost drugs in the centralized bargaining of drugs" and manufacturers of product regulations, according to the principle of low-cost adjustment hanging network.
    It is understood that the introduction of generic drug consistency evaluation, to ensure that generic drugs in the quality and efficacy of the original drug consistent, in the clinical realization of mutual substitution with the original drug, not only conducive to saving medical costs, but also help to improve the quality of generic drugs and the overall level of development of the pharmaceutical industry, to ensure the safety and effectiveness of public drug use.
    more than 5000 pharmaceutical companies in China, 99% are generic drug companies, as many as 190,000 drug approvals, 95% are generic drugs.
    of China's pharmaceutical enterprises mainly generic drugs, in 2018 in the domestic market, generic drugs accounted for 63%, the rest of the innovative drugs 3%.
    Since the 2016 promulgation of the "Opinions on the Quality and Efficacy of Generic Drugs" document, the major generic drug companies have responded positively, after several years of development, generic drug conformity evaluation has made some progress, this time Yunnan added 235 batches of drugs over-conformity evaluation, approved to hang the net, but also once again proved the new progress made in generic drug conformity evaluation.
    data, as of August 2020, 600 enterprises nationwide have actively participated in the evaluation, a total of 533 varieties, 2319 drugs were accepted.
    with the continuous deepening of consistent evaluation, local development will face more intense competitive challenges, but at the same time is full of new opportunities to seize the market and force industrial transformation and upgrading.
    the current situation of consistent evaluation, how should local medical development opportunities be captured? There are industry suggestions, for areas with a good foundation, enterprises can be encouraged to actively expand product lines, especially clinically urgent needs, larger varieties of the market, to support enterprise development of high imitation, difficult to imitate and first imitation drugs, relying on the local generic drug stock enterprises and the introduction of incremental enterprises, to carry out clinical urgent needs, supply shortage, precise efficacy, new patent expiry drug generic development, improve the availability of patients, enhance enterprise competitiveness, seize new markets.
    For areas where the supply of API is insufficient and the development of API industry is limited, the integrated industrial layout of raw materials-preparations across regions should be supported to help enterprises open import channels in order to guarantee the supply of API by local generic pharmaceutical enterprises.
    with the continuous deepening of consistency evaluation, The quality and efficacy of generic drugs in China have been greatly improved, and with the deepening of generic drug conformity evaluation, enterprises are also facing the situation of transformation and upgrading.
    E.e. a large number of generic drug companies can not survive through generic drug development, this old forced generic drug companies to transform, while promoting the survival of China's pharmaceutical companies, many pharmaceutical companies in order to obtain more competitiveness has been strengthening research on new drugs.
    industry said that the future transformation of traditional pharmaceutical companies will be completed in recent years, innovation or imitation will be an option.
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