Affected by the global COVID-19, the overseas production site inspection of imported drugs was blocked in 2020. According to the new deployment of NMPA, CFDI carried out remote inspection of imported drugs for pilot study from Nov. 23 to 27, 2020 and two key imported drugs from Japan and India were conducted respectively in this special inspection.
Following the instructions of NMPA and the guidance of the Office of Drug Supervision, CFDI established an overseas remote inspection research team since July, 2020 to research on various inspection mechanisms and systems. The group conducted a systematic investigation and analysis towards the guidelines, documents and current development status of drug on-site inspections and remote inspections of various drug regulatory agencies around the world. On the basis of research, drawn lessons from the practice of remote inspection by international organizations and relevant countries, and combined with the actual situation of drug inspection in our country, drafted the "Remote Inspection Work Plan for Key Products for Overseas Inspections in 2020" and "Remote Inspection Work for Imported Drug Manufacturers" Procedures and other system documents, and created an remote inspection work plan focused on the quality risks of specific varieties.
Before the official inspection, the inspection team composed of expert-level inspectors held a communication meeting with the domestic agency of imported drugs in advance, focusing on the preparation requirements for the submission of materials. The inspection team will review the materials submitted by the inspected company before the formal implementation of the inspection, re-evaluate and analyze the risk situation and confirm the inspection key points, preparing for high-quality and efficient remote inspections. During the 5-day remote inspection, each inspection team inspected an average of about 600 documents and video materials, communicated with overseas production companies through video communication every day, and conducted online inspections on the variety production line and analysis laboratory.
At present, remote inspections of overseas production sites for the two drugs have been initially completed, and further assessment of the risks and findings during the inspection is ongoing. CFDI will thoroughly summarize the experience of this remote inspection, and further improve the procedures and requirements for the remote inspection of imported drugs during the epidemic prevention and control period. Provide professional technical support for the supervision of imported drugs. Later, remote inspections will be organized based on the actual situation of the epidemic.
