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    Home > Medical News > Latest Medical News > New requirements for related review and approval of the original auxiliary package, implemented on August 15

    New requirements for related review and approval of the original auxiliary package, implemented on August 15

    • Last Update: 2019-07-17
    • Source: Internet
    • Author: User
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    In order to implement the opinions of the general office of the CPC Central Committee and the general office of the State Council on deepening the reform of the review and approval system and encouraging the innovation of pharmaceutical and medical devices (Ting Zi [2017] No 42), the former food and Drug Administration issued the announcement on adjusting the review and approval items of APIs, pharmaceutical excipients and drug packaging materials (2017 No 146) Now it is necessary to further clarify the APIs and pharmaceutical excipients the related review, approval and supervision of the packaging materials and containers (hereinafter referred to as the original auxiliary package) in direct contact with the pharmaceutical preparations are announced as follows: 1 General requirements (1) the use of the original auxiliary package must meet the pharmaceutical requirements, mainly referring to the quality, safety and function of the original auxiliary package should meet the needs of the pharmaceutical preparations The review and approval of the association between the original auxiliary package and the pharmaceutical preparation shall be registered by the original auxiliary package registrant on the registration platform, and the registration information of the platform shall be associated when the pharmaceutical preparation registration applicant submits the registration application; for the original auxiliary package that cannot be registered on the platform due to special reasons, the original auxiliary package research information can also be provided by the pharmaceutical preparation registration applicant at the time of the pharmaceutical preparation registration application (2) The original auxiliary package registrant is responsible for maintaining the registration information of the registration platform and is responsible for the authenticity and integrity of the registration information The domestic original auxiliary package supplier, as the original auxiliary package registrant, shall register its own products The original overseas auxiliary package supplier can be registered by the permanent representative office in China or the entrusted agent in China The registration data shall be in Chinese The original overseas auxiliary package supplier and the agent shall be jointly responsible for the authenticity and integrity of the registration data (3) When applying for drug registration, the applicant for drug preparation registration shall provide the registration number of the original auxiliary package and the authorization for use of the original auxiliary package registrant (4) The applicant for drug preparation registration or the holder of drug listing license shall bear the main responsibility for the quality of drugs, and audit the quality management system of the original auxiliary suppliers according to the relevant requirements of drug registration management and post marketing production management, so as to ensure the compliance with the pharmaceutical requirements (5) The regulatory department shall be responsible for the confidentiality of the technical data submitted by the original subsidiary registrant, and the confidentiality of the technical information of the registration platform The registration platform only publicizes the registration status identification (a or I), registration number, variety name, enterprise name (agency name), enterprise production address, original drug approval number (if any), and the validity of the original approval certificate( If any), product source, specification, update date and other necessary information 2、 Product registration management (6) the original auxiliary package registrant shall register on the platform according to the technical requirements of registration data and obtain the registration number Among them, the API shall obtain the drug production license of the corresponding production range before registration, and shall be registered in accordance with the notice of the former food and Drug Administration on Issuing the requirements for the application materials of new registration classification of chemical drugs (Trial) (2016 No 80); the registration of pharmaceutical auxiliary materials and drug packaging materials shall be registered in accordance with the data requirements of Annex 1 and Annex 2 of this announcement The technical requirements for registration data shall be continuously improved according to the industrial development and scientific and technological progress, and shall be updated and announced by the drug evaluation center of the State Drug Administration (hereinafter referred to as the drug evaluation center) (7) The drug preparation registration application is associated with the registered original auxiliary package When the drug preparation is approved, it means that the associated original auxiliary package has passed the technical review, and the registration platform is marked as "a"; the identification that has not passed the technical review or has not been associated with the preparation registration is "I" (8) In addition to the original auxiliary package banned, eliminated or cancelled by the state, the original auxiliary package meeting the following conditions shall be transferred to the registration platform by the drug audit center and given a registration number, with the registration status marked as "a": 1 The expiry date of the approval certificate shall not be earlier than November 27, 2017; 2 The APIs that have been accepted and reviewed and approved include the API technology transfer application reviewed by the Provincial Bureau in accordance with gsyjz [2013] No 38 document; 3 The pharmaceutical excipients and drug packaging materials that have been accepted and reviewed; 4 The pharmaceutical excipients that have obtained the approval certificate; 5 The expiry date of the approval certificate is not earlier than August 10, 2016 The original subsidiary registrant transferred to the registration platform shall supplement and submit research materials on the Registration Platform in accordance with the requirements of the registration materials of this announcement, improve the registration information, and submit a letter of commitment for data consistency (the technical materials submitted by the registration platform shall be consistent with the technical materials approved for registration) (9) For the APIs used to copy or import the domestic listed pharmaceutical preparations, the API registrant can conduct independent review and approval after registration The registration status of the approved APIs is marked with "a" and that of the unapproved APIs is marked with "I" The time limit and requirements for review and approval shall be implemented in accordance with the current measures for the administration of drug registration and other relevant provisions (10) The pharmaceutical excipients that have been used in food and drug for a long time and whose safety has been recognized may not be registered (see Annex 3 for the list) The product list and basic information shall be listed by the applicant for drug preparation registration in the preparation application materials However, if the drug examination center considers it necessary during the review of the application for drug preparation registration, it may require the applicant for drug preparation registration to provide the corresponding technical data The list of varieties of this kind of pharmaceutical excipients shall be updated and announced by the drug Audit Center in due time (11) Administrative license has been cancelled for pharmaceutical auxiliary materials and drug packaging materials, and no fee will be charged for platform registration API is still an administrative license, and relevant requirements for platform registration technical review shall be implemented in accordance with current regulations and standards 3、 Use and management of the registration information of the original supplementary package (XII) when the research data of the original supplementary package Registration Platform cannot meet the needs of the review, the drug review center may require the drug preparation registration applicant or the original supplementary package registrant to supplement The way to submit the supplementary information shall be specified by the drug Audit Center in the notice of supplement (13) If the API is marked as "a", it indicates that the API has passed the review and approval The API registrant can print approval documents, quality standards and labels on the Registration Platform for GMP inspection and import clearance For APIs that have not been registered on the platform and have submitted research materials together with the registration and application materials of pharmaceutical preparations, the regulatory department shall mark the relevant information of APIs in the pharmaceutical preparation approval documents, which can be used for GMP inspection of APIs, import clearance, etc (14) API manufacturers shall apply for GMP inspection procedures and requirements in accordance with the relevant provisions of current laws and regulations After passing GMP inspection, they shall update the registration information on the registration platform (15) In case of technical change of API marked "a", the application for change shall be submitted in accordance with the relevant provisions of the current drug registration management and implemented after approval Other changes of APIs, pharmaceutical excipients and drug packaging materials shall be updated on the Registration Platform in time and summarized in the annual report of the previous year submitted in the first quarter of each year (16) When the original auxiliary package is changed, the original auxiliary package registrant shall take the initiative to carry out research, timely notify the relevant pharmaceutical preparation manufacturing enterprises (drug listing license holders), and timely update the registration data, which shall be reflected in the annual report After receiving the above notice, the pharmaceutical preparation manufacturing enterprise (the holder of the pharmaceutical listing license) shall promptly evaluate or study the impact of the corresponding change on the quality of the pharmaceutical preparation If the change affects the quality of the pharmaceutical preparation, a supplementary application shall be submitted (17) If the listed pharmaceutical preparations change the original auxiliary package and the original auxiliary package suppliers, they shall be carried out in accordance with the requirements of the technical guidelines for the change of research on listed chemicals (I), the technical guidelines for the change of production process of listed chemicals (I), the technical guidelines for the change of research on listed traditional Chinese medicine (I), and the relevant guidelines for the change of research after the listing of biological products Research and implement in accordance with the relevant provisions of the current drug registration management (18) If the original overseas auxiliary supplier changes the registration agency, it shall be changed after submitting relevant documents Including: reasons for change, power of attorney of the original overseas auxiliary supplier, notarial document and its Chinese translation, copy of business license of the new agency, document of the original overseas auxiliary supplier's cancellation of the original agency's entrustment, notarial document and its Chinese translation 4、 Supervision and Administration (XIX) the drug administrations of all provinces (districts and cities) shall carry out post marketing management according to the drugs with the registration status marked as "a", and carry out GMP inspection (20) Drug administration of each province (district or city) shall strengthen the supervision and inspection of drug preparation manufacturing enterprises (drug listing license holders) in its own administrative region, and urge drug preparation manufacturing enterprises (drug listing license holders) to fulfill the audit responsibility of suppliers of APIs, pharmaceutical excipients and drug packaging materials Pharmaceutical auxiliary materials and pharmaceutical packaging materials manufacturing enterprises with pharmaceutical production license shall continue to manage according to the original management requirements, and register the site information according to the requirements of this announcement after the expiration of the license (21) According to the registration information, the drug administration of each province (district or city) shall strengthen the supervision and inspection and extended inspection on the suppliers of pharmaceutical excipients and drug packaging materials If any quality problem is found in the production of pharmaceutical excipients and drug packaging materials, it shall be investigated and dealt with in a timely manner in accordance with laws and regulations, and the pharmaceutical preparation manufacturing enterprises (drug listing license holders) shall not use relevant products, and shall evaluate and dispose of the listed products The extended inspection shall be organized and carried out by the Provincial Bureau of the place where the pharmaceutical preparation manufacturing enterprise (drug listing license holder) is located The daily inspection of the suppliers of pharmaceutical excipients and drug packaging materials shall be organized and carried out jointly by the local provincial Bureau The on-site inspection for the production of pharmaceutical excipients shall be carried out in accordance with the quality management specification for the production of pharmaceutical excipients (Gya [2006] No 120) The on-site inspection for the production of pharmaceutical packaging materials shall be carried out in accordance with the general principles for the on-site inspection of pharmaceutical packaging materials attached to the measures for the management of packaging materials and containers in direct contact with drugs (Order No 13 of the former State Food and Drug Administration) The drug administration of each province (district or city) can further improve the relevant technical specifications and inspection standards according to the regulatory needs, and promote the steady improvement of the quality level of excipients and drug packaging materials The State Drug Administration will revise relevant inspection standards in time according to the implementation and needs of supervision and inspection in each province 5、 Other (22) APIs, pharmaceutical excipients and drug packaging materials developed, produced, imported and used within the territory of the people's Republic of China are applicable to the requirements of this announcement (23) This announcement will be implemented from August 15, 2019 In case of any inconsistency between the original documents and the requirements of this announcement, this announcement shall prevail The Circular of the former food and Drug Administration on Issuing the requirements for application materials of pharmaceutical packaging materials (Trial) (2016 No 155) shall be repealed at the same time It is hereby announced Annex: 1 Requirements for registration data of pharmaceutical excipients (for Trial Implementation) Doc 2 Requirements for registration data of drug packaging materials (for Trial Implementation) Doc 3 Product catalogue exempted from registration (version 2019) Doc 4 Basic requirements for annual report of pharmaceutical raw excipients and drug packaging materials Doc National Drug Administration July 15, 2019
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