Evidence map›Paper›PMID 30051225›Full record

ReviewInternational journal of clinical pharmacy2018

Pharmacovigilance in China: development and challenges.

Ying Zhao, Tiansheng Wang, Guangyao Li, Shusen Sun

Abstract readReview
PubMed Publisher
In one paragraph

Review in International journal of clinical pharmacy, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 21 papers.

0numbers the graph read from it
0cells of the map it votes in
21citing papers in PubMed
–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

21 citing papers in PubMed.

  1. Observational
  2. A Snapshot on Clinical Trials on Zotarolimus DES: A Repurposing Drug against Myocardial Infarction.The International journal of angiology : official publication of the International College of Angiology, Inc · 2025
    Review
  3. Article
  4. Article
  5. Article
  6. Impact and implications of national centralized drug procurement in China.International journal of clinical pharmacy · 2024
    Article
  7. Article
  8. Review
  9. Article
  10. Article
  11. Article
  12. Article
  13. Pharmacovigilance in China: Evolution and future challenges.British journal of clinical pharmacology · 2023
    Review
  14. Article
  15. Article
  16. Review
  17. Article
  18. Article
  19. Article
  20. Review
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

4 authors.

Ying ZhaoDepartment of Pharmacy, Beijing Friendship Hospital, Capital Medical University, Beijing, China.
Tiansheng WangDepartment of Epidemiology, University of North Carolina, Chapel Hill, NC, USA.
Guangyao LiDepartment of Pharmacy, Beijing Shijitan Hospital, Capital Medical University, Beijing, China.
Shusen SunCollege of Pharmacy and Health Sciences, Western New England University, Springfield, MA, USA. ssun@wne.edu.ORCID http://orcid.org/0000-0001-9014-7329

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background Rational drug use and drug safety are becoming increasingly important concerns in China with the increasing public access to drugs and the health-care system, and this has led to the development of pharmacovigilance in China. Aim of the review To provide a brief introduction about pharmacovigilance in China in terms of system development, utilization and challenges. Method Relevant studies on pharmacovigilance related to the study aim was undertaken through literature search to synthesize the extracted data. Results The creation and evolvement of China's pharmacovigilance system spans across 30 years since 1989. The system consists of four progressing administrative layers: county, municipal, provincial and national levels. China has passed over 20 laws and regulations related to pharmacovigilance covering the processes of drug development, manufacture, distribution and use with the aim to guard drug safety. An online spontaneous self-reporting Adverse Drug Reaction (ADR) Monitoring System was established in 2003. ADRs are mainly reported by medical institutions, pharmaceutical manufacturers, and drug distributors. Currently there is no mandatory ADR reporting requirement for pharmaceutical manufacturers, and a proposed regulation under public comment will likely change this. China has started to build active pharmacovigilance surveillance programs in addition to the passive ADR reporting system. The China Food and Drug Administration has established the intensive Safety Monitoring Program and the National Adverse Drug Reaction Monitoring Sentinel Alliance Program based on electronic health records to further the efforts of ADR reporting, monitoring and analysis. Conclusion The practice of ADR monitoring and pharmacovigilance in China have made great progress. More efforts are needed both in system building, and creation of laws and regulations to strengthen the safe use of medicines.

Indexed as

Adverse Drug Reaction Reporting SystemsDrug and Narcotic ControlPharmacovigilanceChinaDrug-Related Side Effects and Adverse ReactionsGovernment RegulationHumansPatient SafetyPolicy MakingProgram EvaluationRisk AssessmentRisk FactorsAdverse drug reactionsChinaDrug safetyPharmacovigilancePost-marketing monitoring

Identifiers

What OpenQuestion holds

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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 OpenQuestion graph.