Evidence map›Paper›PMID 35165914›Full record

ReviewBritish journal of clinical pharmacology2023

Pharmacovigilance in China: Evolution and future challenges.

Haibo Song, Xiaojing Pei, Zuoxiang Liu, Chuanyong Shen, Jun Sun, Yuqin Liu, Lingyun Zhou, Feng Sun, Xiaohe Xiao

Abstract readReview
In one paragraph

Review in British journal of clinical pharmacology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 31 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
31citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

31 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Levofloxacin-Induced Cutaneous Adverse Reactions: Characteristics and Rational Use Strategies.Medical science monitor : international medical journal of experimental and clinical research · 2026
    Article
  3. A case of levofloxacin injection-induced lower limb edema.Naunyn-Schmiedeberg's archives of pharmacology · 2026
    Article
  4. Review
  5. Article
  6. Article
  7. Article
  8. Article
  9. Article
  10. Understanding social media discourse on antidepressants: unsupervised and sentiment analysis using X.European psychiatry : the journal of the Association of European Psychiatrists · 2025
    Article
  11. Article
  12. Article
  13. Article
  14. Article
  15. Article
  16. Article
  17. Article
  18. Article
  19. Review
  20. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors.

Haibo SongNational Center for ADR Monitoring, Beijing, China.
Xiaojing PeiCenter for Drug Evaluation, NMPA, Beijing, China.
Zuoxiang LiuDepartment of Epidemiology and Biostatistics, School of Public Health, Peking University, Beijing, China.
Chuanyong ShenNational Center for ADR Monitoring, Beijing, China.
Jun SunCenter for Evaluation, Jiangsu Medical Products Administration, Nanjing, Jiangsu, China.
Yuqin LiuGansu Center for Drug and Medical Devices Adverse Reaction Monitoring, Lanzhou, Gansu, China.
Lingyun ZhouLingyun Zhou, Sanofi (China) Investment Co., Ltd, Shanghai Branch, Shanghai, China.
Feng SunDepartment of Epidemiology and Biostatistics, School of Public Health, Peking University, Beijing, China.ORCID 0000-0003-4334-6805
Xiaohe XiaoChina Military Institute of Chinese Medicine, Fifth Medical Center of Chinese PLA General Hospital, Beijing, China.

Funding

National Natural Science Foundation of China 72074011The second batch of Key Projects of Scientific Act for Drug Regulation of China [2021]37-10
6 · The paper itself

Abstract

Drug-related adverse reactions are among the main reasons for harm to patients under care worldwide and even their deaths. The pharmacovigilance system has been proven to be an effective method of avoiding or alleviating such adverse events. In 2019, after two decades of implementation of the drug-related adverse reaction reporting system, China formally implemented a pharmacovigilance system with the Pharmacovigilance Quality Management Standards and a series of supporting technical documents created to improve the safety of medication given to patients. China's pharmacovigilance system has faced many problems and challenges during its implementation. This spontaneous reporting system is the main source of data for China's medication vigilance activities, but it has not provided sufficiently powerful evidence for regulatory decision-making. In conformity with the health-centred drug regulatory concept, the Chinese government has accelerated the speed of examination and approval of urgently needed clinical drugs and orphan drugs along with the requirement to improve the safety supervision of these drugs after their listing. China's marketing authorization holders (MAHs) must strengthen their pharmacovigilance capabilities as the primary responsible departments for drug safety. Chinese medical schools generally lack professional courses on pharmacovigilance. The regulatory authorities have recognized such problems and have made efforts to improve the professional capacity of pharmacovigilance personnel and to strengthen cooperation with stakeholders through the implementation of an action plan of medication surveillance and the establishment of a patient-based adverse events reporting system and active surveillance systems, which will help China bridge the gap to bring its pharmacovigilance practice up to standards.

Indexed as

Drug-Related Side Effects and Adverse ReactionsPharmacovigilanceAdverse Drug Reaction Reporting SystemsChinaDrug and Narcotic ControlHumansChinacurrent situationperspectivepharmacovigilance

Identifiers

PMID35165914
PMCPMC10078654

What Socratic holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.