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    Home > Active Ingredient News > Drugs Articles > China's ban on export-restricted export technology catalogs has affected these pharmaceutical manufacturing projects.

    China's ban on export-restricted export technology catalogs has affected these pharmaceutical manufacturing projects.

    • Last Update: 2020-09-28
    • Source: Internet
    • Author: User
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    On August 28, the Ministry of Commerce and the Ministry of Science and Technology adjusted and issued the China Anti-Export Restriction Technology Directory (Ministry of Commerce, Ministry of Science and Technology Announcement No. 38 of 2020, referred to as the Directory).
    According to the Ministry of Commerce, the head of the Department of Services and Trade on the adjustment issued by the "China's export ban on export restrictions technology catalog" reporters said that the adjustment is based on the "China's export ban on export restrictions technology catalog" (2008 edition) of the adjustment, the main purpose is to standardize the management of technology exports, promote scientific and technological progress and foreign economic and technological cooperation, and safeguard national economic security.
    The adjustment of the Directory has solicited the opinions of relevant departments, industry associations, industry academic circles and the public, involving a total of 53 technical items: first, the deletion of 4 prohibited technical items;
    the pharmaceutical manufacturing industry prohibited export part 1) delete the chemical synthesis and semi-synthetic caffeine production technology (No. 052701J) entry.
    2) delete the entry for the production process of nuclear yellowin (VB2) (No. 052702J).
    3) Delete entries for chemical synthesis and semi-synthetic drug production techniques (No. 052705J).
    Translation of Exports Part 1) the control points of biotechnology drug production technology (No. 052702X) were amended to: 1. The production of toxic species (including wild rats and house mice) by separating and screening strains with industrial production conditions, poison species and their breeding techniques (1) epidemic haemorrhagic fever inactivated vaccines (including wild and house mouse types) 2. Detoxifying strains or strains for live vaccine production and their breeding techniques (1) hepatitis A live vaccine production poisons (2) encephalitis B detoxifying live vaccine production poisons 3. Genetically engineered methods obtained with industrial production conditions of strains, poisons and their breeding techniques 4. Enterovirus 71 inactivated vaccine 5. Oral rotavirus inactivated vaccine 6. EV71 Vaccine Strain 7. CA16 Vaccine Strain 8. Five-price, six-price wheeled vaccine production core process technology 9. Polysaccharin binding technology."
    2) Delete the entry on chemical synthesis and semi-synthetic drug production techniques (No. 052703X).
    3) Delete the entry for natural medicine production technology (No. 052704X).
    4) Delete entries for functional polymer material preparation and processing techniques with bioactive activity (No. 052706X).
    5) Add control points under the preparation and processing technology of tissue engineering medical device products (No. 052707X): "6. Medical diagnostic equipment and equipment manufacturing technology (including domestic next-generation gene detector, third generation single-molecule sequencer)" At the same time, medical diagnostic equipment and equipment manufacturing technology (No. 053604X) control points 4 are removed from the restricted export of professional equipment manufacturing industry.
    In accordance with the Regulations of the People's Republic of China on the Administration of Technology Import and Export, technology export refers to the transfer of technology from within china to abroad through trade, investment or economic and technical cooperation, including the transfer of patent rights, the transfer of patent applications, the licensing of patent implementation, the secret transfer of technology, technical services and other means of technology transfer.
    that is to say, all those involved in the transfer of technology abroad, whether through trade or investment and other means, are subject to the provisions of the Regulations of the People's Republic of China on the Administration of Technology Import and Export.
    technology exports are divided into three categories: freedom, restriction and prohibition, in which the free type of technology after the implementation of the contract registration and record, restrictions on the import and export of technology need to apply for a license.
    2007, the Ministry of Commerce has decentralized the licensing authority for the import and export of restricted technologies to the competent departments of commerce of provinces, autonomous regions and municipalities directly under the Central Government.
    the competent department of commerce receives the application for technology export, it shall conduct a review with the competent department of science and technology, make a decision on approval or non-approval within 30 working days from the date of receipt of the application, and issue a letter of intent for the approval of the technology export license issued to the People's Republic of China.
    the applicant obtains a letter of intent, it may conduct substantive negotiations and sign a technology export contract.
    the applicant to sign a technology export contract, must apply for the People's Republic of China technology export license.
    the competent department of commerce shall review the authenticity of the technology export contract and, within 15 working days from the date of receipt of the relevant documents, make a decision on the licensing or non-licensing of the technology export, and, if granted, issue the Technology Export License of the People's Republic of China.
    technology export shall take effect from the date of the issuance of the technology export license.
    .
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