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    Home > Medical News > Medical World News > Genetics Office continuously issued the approval process is constantly optimized.

    Genetics Office continuously issued the approval process is constantly optimized.

    • Last Update: 2020-10-30
    • Source: Internet
    • Author: User
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    The Genetics Office has issued a series of articles this year, and the approval process for human genetic resources, which has attracted much attention from the research and development community of new drugs in the past two years, is being optimized.
    On the evening of 21 October, the Category Chinese Office for the Management of Genetic Resources (the "Genetics Office") re-issued a further article: Notice on further optimizing the administrative approval process for human genetic resources, which is the 8th document published by the Office of Genetics this year under the website of the Ministry of Science and Technology.
    to further improve the efficiency of approval and shorten the approval time, the Genetics Office has decided to further optimize the approval process for scientific research projects on the collection of human genetic resources and international cooperation, according to the document.
    this time there are two main optimization content: One is to adjust the collection and approval of the submission of ethical review approval approval time, from the online pre-declaration time to submit to the formal acceptance of the submission.
    Second, the time for international cooperation scientific research approval to submit ethical examination approval approval and clinical trial approval, notice or filing publication materials shall be delayed from the submission of online pre-declaration to the time of formal acceptance, but the online pre-declaration shall be submitted with a notice of acceptance of clinical trial approval.
    new drug research and development enterprises concerned about the long-time human genetic resources approval process is being further optimized.
    , since the beginning of the year, the Office of Genetics has issued several documents on optimizing the administrative approval process for human genetic resources.
    Just after New Year's Day this year, on January 7, the website of the Ministry of Science and Technology published the "Notice on the Implementation of a Simplified Approval Process for Some Administrative Approval Projects", and in order to shorten the administrative approval time, it was decided to implement a simplified approval process for some administrative approval projects, the scope of application mainly related to the field of human genetic resources.
    that if there is a change in the course of international cooperation in scientific research activities on human genetic resources, the procedures for approval of changes shall be handled.
    the change does not involve changes in the type, quantity and use of human genetic resources, the changes may be handled in accordance with the simplified process.
    , the same applies to simplified approval processes for exit applications for human genetic resource material that have been approved for exit plans in international cooperation approval.
    the 20th of August, the Genetics Office issued a further Notice on Further Expanding the Scope of Implementation of the Simplified Approval Process.
    notice, some of the administrative approval projects implemented by the Genetics Office in the early stages of the simplified approval process have achieved good results.
    the Genetics Office decided to further expand the scope of implementation of the simplified approval process on the basis of the facts of the previous simplified process.
    , the change of international cooperation scientific research activities of human genetic resources, on the basis of the scope of application in the previous period, increases the name of the legal entity of the partners.
    changes in human genetic resource collection activities are also included in the scope of application to simplify approval.
    through the gradual refinement of management, the Genetics Office is steadily and orderly optimization of the human genetic resources administrative approval process.
    between the two notifications, the Genetics Office also issued a Notice on Emergency Rapid Approval of Projects Related to the Treatment of Pneumonia with New Coronavirus Infections.
    fact, the E drug manager search found that the genetic office in this year's frequency and intensity of the issue more than in previous years.
    last year, the Office of Genetics issued only one training notice, in addition to a "Notice on the Regulations of the People's Republic of China on the Administration of Human Genetic Resources and the Work related to the Pre-Implementation Transition Period".
    July, the Office of Genetics announced that the second half of 2020 the administrative licensing of human genetic resources approval meeting also increased from the first half of the year, the number of the whole year has reached 25 batches.
    indications are that the Genetics Office is accelerating the resolution of the statute of limitations for approval.
    02 Steady progress Recently, more than a thousand words of the newly voted-in Biosecurity Law, which defines the state's sovereignty over China's human genetic resources and biological resources, manages and supervises the collection, preservation, utilization and external provision of clinical trial institutions.
    means that the Genetics Office will become one of the important implementing bodies in the implementation of the Biosecurity Act.
    Fact, as early as 1998, China promulgated the Interim Measures for the Management of Human Genetic Resources, which is the first normative document for the comprehensive management of human genetic resources, opening the era of institutionalization of the protection and utilization of human genetic resources.
    with the rapid growth of biotechnology research activities of human genetic resources, a series of new situations and problems have appeared in the follow-up practice, which put forward higher requirements for the management of human genetic resources in China.
    Subsequently, in 2011 and 2013, the Ministry of Science and Technology issued two "Notices on Further Strengthening the Management of the Protection and Management of Human Genetic Resources";
    this change further strengthens the administrative approval system for collecting and protecting human genetic resources, but it also arouses widespread concern and heated discussion in the clinical trial field.
    for more than a decade, it has been widely understood in the industry that if a human genetic resource specimen export project is involved in a clinical trial, the lead hospital for the trial will be responsible for applying to the Genetics Office for approval.
    the specimen can only be exported after the approval has been obtained.
    application process is so complex that the export of specimens alone greatly increases the operational difficulty of the project.
    time, some analysts believe that in the past only clinical trials of specimen exports were affected, and this time all the clinical trials involving foreign investment, including drugs, devices, vaccines, nutrition, cosmetics and so on.
    the new management methods, clinical trials involving foreign investment will need to apply to the Genetics Office for approval whenever specimens are collected.
    this calculation, the start-up of the entire project may be delayed by 3 to 6 months.
    2017, in order to improve the efficiency of approval and promote research and development of new drugs and medical devices, the Ministry of Science and Technology issued a notice to optimize the approval process, simplifying the approval process for clinical trials using China's human genetic resources, and further clarifying the rights and obligations of both sides in Sino-foreign cooperative research.
    2019, the Regulations of the People's Republic of China on the Administration of Human Genetic Resources were put into effect, clarifying the hierarchical management system for declaration and registration, information filing and security review.
    03 New rules coming soon? In the eyes of the industry, in fact, the earliest promulgation of these documents is out of the protection of genetic resources, China's genetic resources diversity determines the need to protect genetic resources.
    foreign countries have applied for a lot of gene patents, once some Chinese unique genes by foreigners to apply for patents, later use of their own genes to pay a patent fee.
    " but the drug research has played a certain role in blocking, regulation should be practical and convenient to operate.
    resource protection and drug research and development should not affect each other.
    ," the above-mentioned person pointed out.
    , in recent years, the genetic office "the approval process is cumbersome, time-consuming" has become a common headache for new drug research and development enterprises.
    , especially for domestic and foreign innovative drug multi-center research synchronization poses obstacles.
    with the increasing maturity of the innovation environment, clinical trials have burst, "time" has become one of the key elements of the competition of innovative companies.
    , the number of clinical trials conducted in China surpassed that of the United States for the first time in the first half of 2020, according to CoreLogian.
    continue this trend, China will have the largest number of clinical trials in the world by 2020.
    , how to optimize the genetic review and approval process has become an urgent problem to be solved.
    this year, the genetic office issued several simplified process documents, so that the industry once again see hope.
    The Office of Genetics also mentioned in official documents that previous projects to implement simplified processes had achieved good results.
    There is also a view in the industry that there is still a "one size fits all" problem of regulating different types of research, whether it is for clinical studies of drugs, or for research and development activities involving genetic analysis and sequencing, and the collection of human genetic resources in specific areas, the current approach is a unified management approach, which does not reflect the regulatory focus and approval of different research activities.
    , it is reported that soon the biotechnology research and development safety management rules will be issued, the current industry concerns about some operational issues will be further clarified.
    To learn more about the latest developments in policies related to the management of human genetic resources, please pay attention to the 2020 'Chinese Pharmaceutical Entrepreneur Scientists Investors Conference' held at Hangzhou International Expo Center from November 27 to 29, 2020, when we will invite relevant departments and experts to interpret and share.
    to attend, scan the QR code below:
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