Fujian Promulgates Provisional Regulations on the Administration of Drug Safety Complaints and Reporting

To standardize the management of drug, medical device, health food and cosmetics safety complaints and reports, increase the crackdown on illegal activities of “three products and one device” and ensure the safety of food safety for the public. Recently, the Fujian Provincial Food and Drug Administration formulated the “Pharmaceuticals”. Provisional Regulations on the Administration of Security Complaints and Reporting.

First, complaints and reports are accepted. Drug safety complaint reporting agencies at all levels shall record unified code management after receiving complaints and reports, and shall be responsible for special personnel, and shall make a decision on whether to accept the complaint within 5 days from the date of receipt. After the review meets the conditions for acceptance, it shall inform the informant and informer in written form or other appropriate manner within 15 days from the date of acceptance. If it does not meet the conditions for acceptance, it shall be written in writing within 15 days from the date of making the rejection decision. Inform the informant in form or other appropriate way and explain the reasons.

The second is complaints and reports. After investigation and verification, if it belongs to the jurisdiction of the undertaking department or unit, it can be resolved on the same day if it can be resolved on the same day; if it cannot be resolved on the same day, it shall make a reply within 5 days. The acceptance, handling, coordination, review, and feedback of drug safety complaints and reports shall generally be completed within 60 days from the date of acceptance. If the situation is complicated, the time limit for processing may be appropriately extended, subject to the approval of the unit leader of the complaint reporting agency. The extension period must not exceed 30 days, and inform the whistleblower and the relevant complaint reporting agency of the reason for extension.

Thirdly, complaints, reports, and follow-ups urge drug safety complaints and reporting organizations at all levels to follow up on the handling of reported complaints. If necessary, they can use hearing, investigation, inspection, visits, and talks to understand the situation. The contracting department or unit should assist. Cooperate. Complaints and complaints The reporting department or unit shall, after receiving the suggestions for improvement, provide written feedback within 5 days; if no improvement suggestions are adopted, the reasons shall be explained.