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Public consultation on the standard for drug data management (solicitation draftRelease time:2016-09-23 11:57:28 View:
In September 30th, the drug data management standard (Draft) was drafted by the food and drug inspection and inspection center of the State Food and drug administration.           
This is a normative document drafted by our country for the data management in the life cycle of drugs, which indicates that the concept and means of drug administration in China are becoming more and more synchronized with the international advanced level. The introduction of the standard will make the drug industry and regulatory authorities in the field of data management.           
The draft is divided into 6 chapters 54, will cover the data management requirements to all GXP activities in the life cycle of drug development, production, market circulation from the drug, including engaging in the above activities, clinical trials, contract research commissioned production, commissioned the inspection and other units and individuals, and throughout the entire life cycle of data, basic the purpose is to ensure the reliability of data (Data Integrity). Data reliability is the cornerstone of drug quality system to ensure the quality of drugs. This specification will have a far-reaching impact on the pharmaceutical industry in China. It will drive quality management by data management and improve product quality with data quality improvement.           
The industry believes that since last year, a number of advanced countries and international professional organizations in the world have issued the drug data reliability guide document, which shows that the pharmaceutical industry and food and drug regulatory agencies are highly concerned about the reliability of data. Especially in our country since the reform of medical devices since the review and approval system, the food and drug regulatory authorities adopted a series of major initiatives, such as drug clinical trial data verification, generic quality and consistent efficacy evaluation, the regulatory background, introduction of data management practices is particularly important and timely. The introduction of data management standard will enhance the reliability of data, enhance the quality and competitiveness of pharmaceuticals, and widely promote transparent and transparent corporate culture, so as to promote the upgrading of China's pharmaceutical industry and truly have international competitiveness.           
It is reported that the British MHRA released a global GMP data reliability guidelines in January 2015, amended in July extended to GXP; data management guidelines in September 2015 WHO draft, in May this year officially released; PIC/S released in August this year, a more detailed document of the data reliability and reflects the requirements of on-site inspection.