echemi logo
Product
  • Product
  • Supplier
  • Inquiry
    Home > Active Ingredient News > Drugs Articles > 5 pharmaceutical enterprises verify and issue new drug production (operation) licenses

    5 pharmaceutical enterprises verify and issue new drug production (operation) licenses

    • Last Update: 2019-12-12
    • Source: Internet
    • Author: User
    Search more information of high quality chemicals, good prices and reliable suppliers, visit www.echemi.com
    [industry trends of pharmaceutical network] from December 1, 2019, the newly revised Drug Administration Law was officially implemented Article 19 [renewal of Certificate] stipulates that if it is necessary to continue to produce drugs after the expiration of the drug production license, it shall apply to the original license issuing authority for renewal of the drug production license six months before the expiration of the drug production license The original license issuing organ shall, in combination with the enterprise's compliance with the drug management laws and regulations, the drug production quality management specifications and the operation of the quality system, review the application for the drug production license in accordance with the procedures and requirements of these measures, and make a decision on whether to approve the renewal of the drug production license before the expiration of the drug production license If it is approved to change the certificate in accordance with the provisions, it shall take back the original certificate and issue a new one; if it is not, it shall make a written decision not to change the certificate, explain the reasons, and inform the applicant of the right to apply for administrative reconsideration or bring an administrative lawsuit according to law; if it fails to make a decision within the time limit, it shall be deemed that it agrees to change the certificate and go through the corresponding formalities Therefore, the renewal of new drug production (operation) license is an important measure to implement the newly revised Drug Management Law, continuously deepen the reform of "release management service" and optimize the business environment Recently, Qinghai Provincial Drug Administration organized some drug production (operation) enterprises in the province to hold the ceremony of issuing the first batch of new drug production (operation) licenses Five drug production (operation) enterprises including Qinghai KEXILI Pharmaceutical Group Co., Ltd approved the new version of drug production (operation) licenses It is reported that the drug regulatory bureau of Qinghai Province optimized the business process from "two on-site inspections, certification and issuance of two licenses" to "one inspection and issuance of one license" by standardizing the licensing behavior, optimizing the service procedures, simplifying the approval process, streamlining the application materials, and shortening the approval time limit, so as to improve the approval efficiency and service level According to the requirements of Qinghai food and drug administration, enterprises should adapt to the new situation, new regulations and new requirements, strictly implement the newly revised Drug Management Law, further learn and understand, earnestly fulfill the main responsibility of drug quality and safety, strengthen the internal management of enterprises, constantly improve the quality management system of enterprises, and continuously improve the quality control level At the same time, it is required to strengthen the training and assessment of the employees of pharmaceutical enterprises, comprehensively sort out and investigate the quality and safety risks, strengthen the risk control of key links, take effective measures to eliminate and eliminate the hidden dangers in a timely manner, engage in pharmaceutical production and marketing activities in strict accordance with the quality management norms of pharmaceutical production and marketing, and firmly hold the bottom line of pharmaceutical safety It can be seen that with the implementation of the newly revised Drug Management Law, pharmaceutical enterprises must take the main responsibility of drug quality and safety seriously, strengthen enterprise management, carry out production and operation activities in accordance with the law and regulations, and ensure drug quality and safety In addition to Qinghai, Nantong, Deyang City and other places have also clearly launched the new version of drug trade license It is reported that in order to reduce the number of enterprises running errands, Nantong city will not organize the renewal of nearly 3000 pharmaceutical trading enterprises whose licenses have not yet expired within a specified period of time Enterprises can complete the renewal of licenses before the end of December 2020 in combination with the change and other businesses In order to implement the new drug administration law, Deyang City should actively respond to the "centralized license renewal year" of drug enterprises, and the municipal market supervision bureau and other departments should take four measures, such as promising the excellent license renewal process, which greatly shortens the license renewal time It is advisable to change the approval time limit of drug trade license renewal from the original 86 working days to standing.
    This article is an English version of an article which is originally in the Chinese language on echemi.com and is provided for information purposes only. This website makes no representation or warranty of any kind, either expressed or implied, as to the accuracy, completeness ownership or reliability of the article or any translations thereof. If you have any concerns or complaints relating to the article, please send an email, providing a detailed description of the concern or complaint, to service@echemi.com. A staff member will contact you within 5 working days. Once verified, infringing content will be removed immediately.

    Contact Us

    The source of this page with content of products and services is from Internet, which doesn't represent ECHEMI's opinion. If you have any queries, please write to service@echemi.com. It will be replied within 5 days.

    Moreover, if you find any instances of plagiarism from the page, please send email to service@echemi.com with relevant evidence.