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The reform of pharmaceutical equipment has expanded from review, review and approval to the reform of the regulatory system

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  • Time of issue:2017-11-19
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(Summary description)Recently,the General Office of the Central Committee of the Communist Party of China and the General Office of the State Council jointly issued the"Opinions on Deepening the Reform of the Review and Approval System to Encourage Innovation in Drugs and Medical Devices"(hereinafter referred to as the"Opinions").After the“Opinions on the Review and Approval System”,another programmatic document to deepen the reform of the drug and medical device review and approval system can be understood as a comprehensive summary and deepening of the two-year review and approval system reform experience.Concentrated embodiment of the strategic decision-making deployment of drug supervision.

The reform of pharmaceutical equipment has expanded from review, review and approval to the reform of the regulatory system

(Summary description)Recently,the General Office of the Central Committee of the Communist Party of China and the General Office of the State Council jointly issued the"Opinions on Deepening the Reform of the Review and Approval System to Encourage Innovation in Drugs and Medical Devices"(hereinafter referred to as the"Opinions").After the“Opinions on the Review and Approval System”,another programmatic document to deepen the reform of the drug and medical device review and approval system can be understood as a comprehensive summary and deepening of the two-year review and approval system reform experience.Concentrated embodiment of the strategic decision-making deployment of drug supervision.

  • Categories:Industry News
  • Author:
  • Origin:
  • Time of issue:2017-11-19
  • Views:0
Information

  Recently,the General Office of the Central Committee of the Communist Party of China and the General Office of the State Council jointly issued the"Opinions on Deepening the Reform of the Review and Approval System to Encourage Innovation in Drugs and Medical Devices"(hereinafter referred to as the"Opinions").After the“Opinions on the Review and Approval System”,another programmatic document to deepen the reform of the drug and medical device review and approval system can be understood as a comprehensive summary and deepening of the two-year review and approval system reform experience.Concentrated embodiment of the strategic decision-making deployment of drug supervision.


  In order to understand the New Deal more deeply and closely follow the changes of the New Deal to adjust the industrial layout,November 7-10,under the guidance of the Southern Institute of Pharmaceutical Economics of the State Food and Drug Administration,sponsored by the Pharmaceutical Economic News,and undertaken by Punctuation Information(Group)"The 29th National Medical Economic Information Conference"will be held in Changzhou,Jiangsu.The theme of this conference is"Resonant Upward Industrial Support-China's Pharmaceutical Economy Resilience and Tension".The meeting will implement the spirit of the"19th National Congress"of the party,focus on interpreting the policy points of the"Opinions",carry out policy discussions,and conduct a five-year mid-term forecast of the domestic and foreign pharmaceutical market and R&D trends.At the meeting,Nanfang Institute and Meinenet will release more than ten research reports on the frontier and hot topics of the pharmaceutical industry.The Pharmaceutical Economic News has gathered more than 100 expert judges from the industry and economic circles,the media,academies,industry associations,and third-party research institutions to launch the"2017 China Pharmaceutical Economy Annual Figures"selection,which will be announced at this press conference.result.


  In terms of policy interpretation,the main contents include the trend of China's economic reform after the 19th National Congress of the Communist Party of China,new developments in the drug review and approval system,new developments in drug regulatory policies and regulations,new trends in the reform of the medical insurance payment system,and new developments in medical reform policies.As one of the main sections of the information conference,in terms of data release this year,there will be 2018 pharmaceutical economic forecasts and outlook for the next 5 years,the characteristics and future development trend forecasts of the three major terminals and six markets,the market characteristics and trends of large varieties of Chinese medicine,Consistency evaluation catalog variety market characteristics and trends,pharmaceutical industry park characteristics and trends,etc.


  In fact,with the rapid advancement of the medical reform process and the acceleration of the implementation of policies in various regions,major changes have taken place in the medical field.The relevant person in charge of the State Food and Drug Administration clearly stated at a foreign press conference held a few days ago,“The reform has gradually expanded from the field of review and approval to a comprehensive reform of the regulatory system,realizing the full life cycle management of drugs and medical devices,and supervising Reform and innovation cover all aspects of research and development,production,circulation,and use,and use regulatory innovation to stimulate industrial innovation."


  Since the"18th National Congress of the Communist Party of China",the policy environment and institutional environment of drug innovation have undergone great changes.In recent years,more and more medical researchers with overseas work experience have returned to China for research and entrepreneurship,and the number of new drug applications and approvals for domestic pharmaceutical companies has increased year by year.The reform of the drug and medical device review and approval system that began in 2015 has improved the review quality standards,rectified the unfavorable trend of falsification of drug clinical trial data,and enhanced the transparency of review and approval.A batch of innovative drugs and medical devices were given priority to be approved for marketing,and international A conforming drug and medical device review system is gradually established.In February 2016,the General Office of the State Council issued a document that clarified the relevant policies for consistency evaluation,and some local governments also issued relevant support policies.The enthusiasm of enterprises to participate in consistency evaluation is very high.In November 2015,the National People's Congress authorized the launch of a pilot marketing license holder system in ten provinces and cities,which inspired the enthusiasm of scientific researchers for innovation,and many provinces and cities required universal implementation across the country.


  In response to the current outstanding issues facing the innovation of pharmaceuticals and medical devices,the"Opinions"propose to reform clinical trial management,speed up marketing review and approval,and promote the innovation of pharmaceuticals and medical devices and the development of generic drugs.In response to the shortage of clinical research resources,the"Opinions"proposed that the qualification accreditation of clinical trial institutions should be changed to record management.It is proposed to speed up the review and approval of clinically urgently needed drugs and medical devices,allow conditional approval for listing,and conduct supplementary research as required after listing.At the same time,the"Opinions"proposed to explore the establishment of a series of reforms such as the establishment of drug review and approval and drug patent linkage systems,patent term compensation systems,and clinical data protection systems.


  As a pharmaceutical industry,as a pharmaceutical company,how should we understand the essence of the"Opinions",correctly grasp the key points of policies,and how to use policies to promote our own development?Relevant interpretations at this information conference can make you rewarding.

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