Market Supervision Bureau, safe and effective drugs and devices

Answer 1

The Market Supervision Bureau has taken a variety of effective measures to ensure the safety of drugs and devices:

* * 1. In terms of approval **
1. * * Strictly enforce drug and device's "admission"**
- For example, the Mentougou District Market Supervision Bureau started from the source and strengthened the review of license standards. Since the beginning of this year, it has carried out 105 inspections of drug and device permits, completed 265 administrative permits of drugs and devices (including 48 drug permits and 217 medical device permits, an increase of 23.8% compared with 2023), completed the annual report review of 163 Class III medical device operating enterprises in the jurisdiction on time (an increase of 19.0% compared with 2023), and ensured that the drug and device operating entities were in compliance with the law through strict inspections.
2. * * To ensure the legitimacy of the business entity **
- The local market supervision bureau strictly reviewed the drug and device license to prevent unqualified business entities from entering the market, so as to ensure the reliability of the source of drugs and devices. This was the primary link to ensure the safety of drugs and devices.

* * 2. Supervision and Inspection **
1. * * Carry out comprehensive inspection work **
- formulate a supervision plan and identify the key links. For example, Mentougou District focused on drug purchase channels, storage conditions, sales management, etc., and comprehensively organized the inspection of drug and device operating enterprises. Since the beginning of this year, a total of 626 daily supervision and inspections have been carried out, including 272 pharmaceutical companies and 354 medical device companies.
- The supervision bureau of many places focused on township hospitals, health centers, private hospitals, rural drugstores, and village health institutions. By reading the information, checking the drug management, and checking the qualification of the supplier, the medical institution will conduct a comprehensive inspection of the use of drugs and devices, including the quality of drugs, the safety of medical devices, and other aspects, such as the purchase channels, storage conditions, and shelf life management of drugs, as well as the purchase, acceptance, use, and maintenance of medical devices.
2. * * Inspecting key areas and species **
- Many regional supervision departments paid close attention to key areas such as rural areas, urban and rural junction areas, community hospitals, etc., and carried out in-depth investigation of hidden dangers. They also focused on key varieties such as vaccine, specially-managed drugs, Chinese herbal pieces, and inspected their purchase and sales channels, storage and transportation, and other key links.
- For example, check whether there are illegal sales of psychiatric drugs, medical institutions 'preparations, traditional Chinese medicine formula granules and other prohibited online sales of drugs; whether there are illegal sales of drugs, sales of recycled drugs, purchase of drugs from illegal channels; whether there are sales of prescription drugs without prescriptions, non-drugs pretending to be drugs and other acts of manufacturing and selling counterfeit drugs.
3. * * Find problems and rectify them in time **
- During the inspection process, the problems found were dealt with in a timely manner. If some medical institutions had problems such as irregular drug storage, incomplete medical device maintenance records, delayed operation of various account records, inconsistent display and storage conditions of drugs and drug instructions, incomplete registration of purchase and acceptance records of drugs and medical devices, and mixed Chinese herbal pieces, the supervision bureau put forward suggestions for correction on the spot and requested immediate correction. For some of the more serious problems, such as issuing a notice of correction or filing a case for investigation, issuing a notice of order to correct the behavior of practicing pharmacists not selling prescription drugs on duty, not displaying and storing drugs according to the temperature and humidity specified in the instructions, and filing a case for investigation and investigation of the use of medical devices beyond the validity period.

* * 3. Awareness and education **
1. * * Promotion of laws, regulations and safety knowledge **
- Use a variety of publicity platforms to promote the basic knowledge of safe and rational use of drugs. For example, the Jiangyan District Market Supervision Bureau of Taizhou City made full use of text messages, newspapers, WeChat public accounts, LED screens and other publicity platforms to publicize the laws and regulations related to drug supervision through multiple channels and methods.
2. * * Organizing relevant personnel to participate in the competition and learn **
- The main persons-in-charge of retail drugstores, the registered pharmacists, the legal representatives, and the technical personnel engaged in drug quality management in medical institutions were organized to participate in the drug safety knowledge network competition, forming a situation where the competition promoted learning and applied what they learned, so as to improve the safety awareness and responsibility awareness of relevant personnel and indirectly guarantee the safety of drugs and devices.
3. * * Carry out offline science promotion activities **
- In densely populated areas, scientific publicity activities were held simultaneously to educate the passing masses on drug safety, counterfeit drug identification, and consumer rights protection knowledge. Drug safety publicity manuals were distributed and consulted. For example, the Jiangyan District Market Supervision Bureau of Taizhou City carried out such activities in South Street, Luotang Comprehensive Market, Qintong Town Commercial Street, and other places.

* * IV. Random inspection and monitoring **
1. * * Reasonably assign random inspection tasks **
- Based on the problems found in the daily supervision and inspection, the random inspection tasks of drugs and devices should be reasonably assigned and the random inspection should be carried out in a standardized manner. For example, the Mentougou District Market Supervision Bureau had completed the spot check of 85 district-level drugs (one of which was unqualified and had been filed for punishment) and 8 medical devices (all qualified) in the circulation of drugs and devices as planned. It also completed the spot check of 2 batches of national drugs and 9 batches of medical devices (all qualified) assigned by the Beijing Drug Administration on time. Through random inspection and monitoring, the quality problems of medical devices could be discovered in time to ensure the safety of medical devices on the market.
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