National Medical Products Administration: Revised Drug GMP to be Issued in the First Half of the Year

Business Society, January 20th - According to reports from the National Food and Drug Administration's National Supervision and Administration of Food and Drug Work and Party Conduct and Clean Governance Construction Work Conference, the technical work for the revision of the highly anticipated "Good Manufacturing Practices for Pharmaceuticals" (revised in 2010) has been largely completed and is awaiting final review by the regulatory department. It is expected to be published in the first half of this year. The newly established enterprises, basic drug manufacturers, and injectable drug manufacturers will be the first to implement the revised Drug GMP.

According to Sun Xianze, Director of the Drug Safety Supervision Division of the State Food and Drug Administration, the revised Drug GMP has increased hardware requirements and further strengthened software requirements. It emphasizes the quality management of the drug production process, which helps ensure drug quality and safety. After the revised Drug GMP is issued, the National Administration will focus on promoting and implementing it. The newly established enterprises, basic drug manufacturers, and injectable drug manufacturers should be the first to implement it. At the same time, the National Administration will also promptly organize the drafting and revision of relevant appendices, the development of technical guidelines, and the research and formulation of a work mechanism that combines Drug GMP certification with routine inspections and on-site verifications during drug registration. It will also summarize and extract the experiences and practices of implementing the authorized person system for quality and non-site supervision of drugs in various regions. In addition, the management mechanism for Drug GMP certification will be improved. In conjunction with the implementation of the revised Drug GMP, the National Administration will enhance training for regulatory personnel, especially GMP inspectors.

It is understood that the revised Drug GMP is highly consistent with international standards for pharmaceutical GMP in terms of stringency and broadly meets the current regulatory needs in China. It reflects both the characteristics of drug production and regulatory practices in China and meets current international standards. (Reporter: Chen Jing).