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The Dawan District Center for Drug Evaluation and Inspection of the National Medical Products Administration took the lead in launching the on-site inspection of drug registration

The Dawan District Center for Drug Evaluation and Inspection of the National Medical Products Administration took the lead in launching the on-site inspection of drug registration

  • Categories:Company News
  • Author:
  • Origin:State Drug Administration
  • Time of issue:2021-07-08
  • Views:0

(Summary description)In order to implement the work deployment of the National Medical Products Administration and perform its duties as soon as possible to carry out business work, from May 8 to 13,

The Dawan District Center for Drug Evaluation and Inspection of the National Medical Products Administration took the lead in launching the on-site inspection of drug registration

(Summary description)In order to implement the work deployment of the National Medical Products Administration and perform its duties as soon as possible to carry out business work, from May 8 to 13,

  • Categories:Company News
  • Author:
  • Origin:State Drug Administration
  • Time of issue:2021-07-08
  • Views:0
Information

  In order to implement the work deployment of the National Medical Products Administration and perform its duties as soon as possible to carry out business work, from May 8 to 13, 2021, the Greater Bay Area Center for Pharmaceuticals took the lead in launching the first on-site inspection of drug registration since its listing.

  In the early stage, with the strong support of the inspection center, the Greater Bay Area Center for Pharmaceuticals made sufficient preparations for the inspection, carefully studied inspection plans, wrote inspection documents, and selected inspection team members from the national inspector pool of Guangdong Province. The team leader is a senior inspection expert, and the team includes senior inspection experts and experienced review and inspection backbones. In order to ensure the quality and efficiency of the inspection tasks, the Center for Pharmaceuticals Greater Bay Area organized a pre-inspection communication meeting on May 6. Cao Yi, Director of the Inspection Center of the State Drug Administration, Huang Xiaolong, Director of the Dawan District Center for Pharmaceuticals, and all members of the inspection team attended the meeting. At the meeting, Director Huang Xiaolong read out the "Guidelines for Inspection Work Discipline and Integrity of the Dawan District Center for Pharmaceuticals", and made recommendations on the key points of inspection from the perspective of professional review.

  The inspection team went to Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Co., Ltd. and Guangzhou Aige Biotechnology Co., Ltd. after making sufficient preparations in the early stage, to research and produce the beemetol timolol eye drops and epismid hydrochloride. The eye drops undergo a 6-day on-site verification work. The Guangdong Provincial Drug Administration simultaneously implemented pre-market drug GMP compliance inspections.

 

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  During the inspection, the members of the inspection team carefully checked the registration application materials and experiment-related documents submitted by the applicant, and inspected the research and development sites and production workshops on the spot. In the case of tight time and heavy tasks, work overtime or even all night to strictly review the information. In order to improve the quality of inspections, daily inspection summary meetings are held to promote inspections in an orderly manner. After the verification task, the inspection team carefully studied and discussed the problems found on the spot, and put forward pertinent suggestions to the enterprise. The professionalism and professionalism of the inspection team were highly praised by the Guangdong Drug Administration, Guangzhou Market Supervision Administration and the applicant.

  In the future, the Pharmaceutical Greater Bay Area Center will regularly carry out on-site inspection tasks for drug registration in the Greater Bay Area according to the work arrangements of the National Bureau and the Verification Center, continuously strengthen communication and coordination with regulatory authorities at all levels in the Greater Bay Area, and continue to promote professionalism The construction of a professional inspector team has steadily promoted the normalization of the registration and inspection work of the Pharmaceutical Greater Bay Area Center, and comprehensively assisted the innovative development of the pharmaceutical industry in the Guangdong-Hong Kong-Macao Greater Bay Area.

 

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