• Overall Situation of the Report for Adverse Drug Reaction/Event (ADR/ADE) Monitoring

In 2020, the China National ADR Monitoring Network received 1.676 million copies of ADR/ADE Reports. From 1999 to 2020, the National ADR Monitoring Network received a total of 16.87 million copies of ADR/ADE Reports.

In 2020, the National ADR Monitoring Network received 506,000 reports of new and serious ADRs/ADEs, accounting for 30.2% of the total number of reports in the same period.

In 2020, the National ADR Monitoring Network received 167,000 reports of serious ADRs/ADEs, accounting for 10.0% of the total number of reports in the same period.

Through the efforts of various parties, the enthusiasm of MAHs, distributors and medical institutions in ADR reporting has been gradually increased, and the number of ADR reports in China has been on the rise in general. The proportion of serious ADRs/ADEs reports is one of the important indicators to measure the overall quality and usability of reports. The collection and evaluation of new and serious ADRs has been the focus of ADR monitoring and evaluation. The increase in the number of reports of new and serious ADRs, especially reports of serious ADRs, rather than indicating the decrease in drug safety level, means that regulatory authorities have mastered the information more comprehensively and have had more understanding of drug risks, more control over drugs and more basis for drug evaluation to make more accurate policy decision on supervision. Similarly, understanding the manifestation and degree of ADRs in medical practice in a timely manner and avoiding them to the greatest extent is also an important measure to ensure safe drug use of patients.

• Monitoring of Essential Drugs

In 2020, the National ADR Monitoring Network received a total of 830,000 ADR/ADE reports of the varieties included in the National Essential Drugs List (2018 Edition), of which 88,000 were reports of serious ADRs/ADEs, accounting for 10.6%. Reports involving chemical drugs and biological products account for 88.1% and those involving traditional Chinese medicines account for 11.9%.

The sections of chemical drugs and biological products in the National Essential Drugs List (2018 Edition) involved a total of 417 (categories) varieties. In 2020, the National ADR Monitoring Network received a total of 781,000 ADR/ADE reports of chemical drugs and biological products in the National Essential Drugs List, of which 104,000 were reports of serious ADRs/ADEs, accounting for 13.4%.

In 2020, according to the statistics of drug categories, for chemical drugs and biological products in the National Essential Drugs List, the top 5 drugs in terms of the number of reports were antimicrobial drugs, drugs for cardiovascular diseases, antineoplastic drugs, drugs for hormone and drugs for impacting endocrine system and drugs for treating mental disorders; the top 5 involved organs and systems were gastrointestinal disorders, skin and subcutaneous tissue diseases, systemic diseases and various reactions at the site of administration, nervous system disorders and examinations.

The traditional Chinese medicines in National Essential Drugs List (2018 Edition) involved a total of 268 varieties. In 2020, the National ADR Monitoring Network received a total of 105,000 ADR/ADE reports of the traditional Chinese medicine in the National Essential Drugs List, of which 6,358 were reports of serious ADRs/ADEs, accounting for 6.0%. In 2020, as for the 7 main categories of traditional Chinese medicines in the National Essential Drugs List, their descending order in terms of the total number of their ADR/ADE reports was successively internal medicine, orthopedic medicine, gynecological medicine, surgical medicine, ENT medicine, pediatric medicine, and ophthalmic medicine.

The monitoring data above demonstrate that the overall situation in 2020 of national monitoring of essential drugs remained basically stable.