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The Center for the Greater Bay Area of Pharmaceuticals successfully held a series of special training sessions on technical guidelines for post-marketing drug changes

The Center for the Greater Bay Area of Pharmaceuticals successfully held a series of special training sessions on technical guidelines for post-marketing drug changes

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

(Summary description)From May 18th to 19th, sponsored by the Center for Drug Evaluation and Inspection of the National Medical Products Administration of the Greater Bay Area (hereinafter referred to as the Greater

The Center for the Greater Bay Area of Pharmaceuticals successfully held a series of special training sessions on technical guidelines for post-marketing drug changes

(Summary description)From May 18th to 19th, sponsored by the Center for Drug Evaluation and Inspection of the National Medical Products Administration of the Greater Bay Area (hereinafter referred to as the Greater

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

  From May 18th to 19th, sponsored by the Center for Drug Evaluation and Inspection of the National Medical Products Administration of the Greater Bay Area (hereinafter referred to as the Greater Bay Area Center for the Drugs), guided by the Center for Drug Evaluation of the National Medical Products Administration (hereinafter referred to as the Center for Drug Evaluation) Special training sessions on post-marketing drug changes organized by the Guangdong Provincial Drug Administration (hereinafter referred to as the Guangdong Provincial Drug Administration), the Shenzhen Municipal Market Supervision Administration (hereinafter referred to as the Shenzhen Municipal Market Bureau) and the Shenzhen Association of Life Sciences and Biotechnology are held in Shenzhen The City Sentosa Hotel was held successfully.

 

灵泽

 

  The Center for the Greater Bay Area of Medicines specially invited 12 review experts from the Center for Drug Evaluation who participated in the drafting of technical guidelines for post-marketing change research to come to Shenzhen for training. Experts gave a comprehensive and detailed explanation on the post-marketing change research involving traditional Chinese medicine, chemical drugs and biological products at the meeting. During the interactive Q&A session, representatives of participating companies enthusiastically asked questions, and review experts provided patient answers to common questions raised related to post-listing change research. A total of more than 500 people from the Guangdong Provincial Drug Administration, Shenzhen Municipal Marketing Bureau and related directly affiliated units, as well as representatives of drug R&D and production enterprises in the Greater Bay Area, participated in the training. At the same time, in order to meet the training needs of the personnel of a wider range of enterprises and institutions, the Pharmaceutical Dawan District Center has set up an online branch and opened an online live broadcast platform to conduct simultaneous live broadcast of the whole training process and synchronized online live broadcast. The number of participants has exceeded 90,000.

 

灵泽

 

灵泽

 

  This training session is the first large-scale special training for pharmaceutical companies in the region after the Center for the Greater Bay Area of Medicines officially launched the review-related business work. It aims to help drug marketing authorization holders to change their work after the market. The requirements of the relevant national guidelines can be taken into consideration at the beginning, avoid deviations or major omissions from the source, thereby improving the quality and speed of approval of drug changes after the drug market. At the same time, it will help the drug marketing license holder to continuously improve and optimize the production process throughout the life cycle of the drug, and continuously improve the quality of the drug.

 

灵泽

 

  Huang Xiaolong, director of the Center for the Greater Bay Area of Pharmaceuticals, said that in line with the principle of providing services while preparing for construction, the sub-center is steadily advancing various review-related business tasks. This training meeting is of great significance to deepen the understanding of drug companies in the region on post-marketing change research, and also to ensure that the relevant business work of the sub-center is included in the review system of the drug review center to achieve a unified review process and a unified review Scale exploration. In the follow-up, the branch will establish a tripartite working mechanism with the Drug Approval Center and the Guangdong Provincial Food and Drug Administration for the determination of post-marketing drug classification changes, and draft and formulate relevant procedures and requirements to further improve the determination of drug companies in the region Efficiency and reduce repeated declarations.

  Representatives of the participating companies expressed that the training meeting was held in a timely manner, allowing companies to obtain professional guidance from the beginning of the release of the regulatory and technical guidelines for changes to the drug after the listing, which greatly enhanced the confidence of the companies to do a good job in the change of drugs after the listing. .

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