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组合产品法规介绍 - fda.gov.t · PDF fileMedical Device Combination Products >(SFDA,No. 16, 2009 ... Requirement for Combination Product Registration ... in a drug -device

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Text of 组合产品法规介绍 - fda.gov.t · PDF fileMedical Device Combination Products...

  • Combination Product Regulation & Supervision In China

    State Food and Drug Administration Medical Device Dept.

  • Combination Products Supervision Requirements

    2009 16

    SFDA No. 16, 2009

    URLhttp://www.sfda.gov.cn/WS01/CL0087/43215.html

    2

  • Combination Product Definition

    Combination Product Application Pathway

    Combination Product Categorical Application

    Combination Product Categorical Authority and Timeline

    3

  • Application Based on the Category and Classification of the Combination Product

    /

    Country of Origin Requirement for Combination Product Registration Application

    Drug-Device Coordination and Joint Evaluation Mechanism

    Combination Product Examples

    Promulgation Timeline4

  • + =

    Drug + Medical Device = Combination Products (one entity)

    5

    Definition of Combination Products

  • If drug plays the leading roleapply for drug registration

    If medical device plays the leading roleapply for medical device

    registration

    6

    Registration Application Pathway

  • Application Acceptance Authority: Administrative Processing Service Center

    of the State Food and Drug Administration

    Application Supporting Documents: explanation and relevant supporting

    materials for the product to facilitate decision making whether the product will be

    registered as a drug or medical device

    7

    Combination Product Categorical Application

  • Authorities: The Administrative Processing Service Center of the State Food and Drug Administration

    The Center of Drug Evaluation

    The Center of Medical Device Evaluation

    Timeline20 Within 20 working days

    8

    Combination Product Categorical Decision Making

    Authority and Timeline

  • Review Authority: State Food and Drug Administration

    Application Pathway: apply for drug registration or medical device registration

    *

    * Indicate drug and medical device combination product

    9

    Application Based on the Category and Classification of the Combination Product

  • If the combination products have not been approved for sale in the export country

    (region), and if the drug in a drug - device combination product has not been registered

    in China or has not been approved for sale in the country (region) of manufacturer ,

    then the application will not be accepted.

    10

    /

    Country of Origin Requirement for Combination Product Registration Application

  • The Center of Drug Evaluation and the Center of Medical Device Evaluation

    will establish a coordinative mechanism

    Technical review lead by leading party; joint-effort review; simultaneous

    review.

    Corresponding department of the State Food and Drug Administration for

    administrative evaluation and approval.

    11

    Drug-Device Coordination and Joint Evaluation Mechanism

  • Drug-eluting Stent

    Antibacterial-coated catheters

    Condoms with drug

    Contraceptive rings with drug

    Wound dressings with antibacterial and anti-inflammatory drugs

    Patches which contain traditional Chinese medicine for external

    12

    Combination Product Examples

  • 2009.11.12

    Come into force as of the date of promulgation November 12, 2009

    13

    Promulgation Timeline

  • THANK YOU

    14

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