Nationally, China has also made notable progress in the sector. Bi Jingquan, deputy director of the economic committee of the National Committee of the Chinese People's Political Consultative Conference, the top political advisory body, noted that since 2015, China's drug regulatory agency has appr...
drug regulatory agencyObjective To identify and reduce the gap between China's drug GMP inspection and pharmaceutical inspection co-operation scheme(PIC/S)audit checklist,find out the key improvement items,and revise them pertinently,which will promote the process of China joining PIC/S.Methods The ...
“The Chinese government recently published the final plan to restructure its food, drug and medical device regulatory agency, now named the China Food and Drug Administration (“CFDA”), defining the boundary of its authority and its collaboration with peer agencies in the central government.” Re...
China is the second-largest drug market in the world.Registering drugs in Chinais more accessible today than ever. That does not mean it is easy or straightforward. Before attempting to do so, international drug companies should research the prevalence of the disease their specific drug treats in...
which helped the U.S. biotech secure the leadership position ahead of competitors from China. Not only the U.S. leads in biotech patent filings, the country’s regulatory agency, the Food and Drug Administration (FDA) als...
All regulatory changes in 2010/2011 are updated to present a clear and most up-to-date picture of the Chinese drug regulatory framework with summaries and analysis of all drug regulations in effect by June 30, 2011. New and expanded coverage on MNC strategies in China with health...
Appointment letter for the Chinese agency Drug approval from the authority of the country of origin GMP and production authorization letter from the country of origin Application form filled out by the Chinese agency M2: Summary Table for Main Study ...
FDA Issues Draft Guidance on the Role of Artificial Intelligence in Supporting Regulatory Decisions Andy Studna, Senior Editor January 7th 2025 Article This framework marks the agency’s first official recommendation on the use of AI in drug development. About...
Article 7In the process of drug registration, the drug regulatory department shall make known to the general public, and hold hearings on, the matters which it deems of vital importance and involving public interests for the granting of permission. ...
“5.2.5.1 National drug regulatory authority shall construct a harmonization platform to provide accurate basic information on drug categories and manufacturers, provide such services as filing and management of coding rules for drug traceability code and various drug traceability system addresses, so as ...