How to prepare the annual report of drug marketing license holders in the implementation of the new administrative law

Wen Di Di Si Nan The new drug administration law will come into force on December 1, 2019 2020 is the start year of the new regulatory era after the implementation of the new drug administration law How to report the drug annual report in 2019? What is it reported? It is one of the most urgent concerns of MAH Article 37 of the new drug administration law (No 31 order of the president in 2019), which came into force on December 1, 2019, stipulates that: the holders of drug listing licenses shall establish an annual reporting system to report the production and sale of drugs, post marketing research, risk management, etc to the drug regulatory departments of the people's governments of provinces, autonomous regions and municipalities directly under the central government in accordance with the provisions; Article 60 of the vaccine management law (No 30 order of the president of the people's Republic of China in 2019), which came into force on December 1, 2019, stipulates that: the holders of vaccine marketing licenses shall establish a vaccine quality retrospective analysis and risk reporting system, and report the production and circulation of vaccines, post marketing research, risk management and other information to the drug regulatory department of the State Council according to the provisions The new drug administration law (No 31 order of the president in 2019) stipulates that the holder shall submit the annual report to the Provincial Bureau in accordance with the provisions of the newly revised Drug Administration Law; The vaccine management law (No 30 presidential order in 2019) stipulates that vaccine holders shall submit annual reports to the National Bureau in accordance with the vaccine management law of the people's Republic of China According to the source, the State Food and Drug Administration and provincial food and drug administration are debugging the drug annual report submission and management platform According to the current situation of epidemic prevention and control, the author predicts that the State Food and Drug Administration will soon issue the regulations on the administration of annual drug reports, which may require the holders of drug listing licenses to prepare annual reports by March 31 of each year and complete the reports through the national drug annual report submission and management platform The new drug administration law and vaccine administration law stipulate that the production and sale, post marketing research and risk management of drugs shall be reported to the relevant drug supervision and administration departments in accordance with the regulations every year The author suggests that the drug marketing license holders shall establish an annual report system in advance, and refer to the guidance for Industry CMC postapproval manufacturing changes to be of FDA Documented in annual reports, including at least the following aspects: