Problems within the post-marketing surveillance system in Korea: Time for a change
Translational and Clinical Pharmacology
;
: 63-65, 2016.
Article
in English
| WPRIM
| ID: wpr-60364
ABSTRACT
Post-marketing safety studies are an important tool for understanding and monitoring the safety profiles of drugs in the clinical setting. Their importance has attracted not only the attention of regulators for reinforcing legislation but also led to recent changes in European Union (EU) regulations; these regulations have influenced the practice of Post-Authorization Safety Study (PASS) by marketing authorization holders. Korea conducts post-marketing surveillance (PMS) studies, but their execution is very different. This editorial reviews the PMS system in Korea in comparison with the recent legislative changes affecting the EU system. Ultimately, it suggests that changes to the PMS system are necessary to obtain quality safety data while maintaining a global standard of operation. Such efforts to refine the system will enhance the credibility of the PMS in Korea and, in due course, produce safety profiles that will be valuable for public health.
Full text:
Available
Index:
WPRIM (Western Pacific)
Main subject:
Social Control, Formal
/
Public Health
/
Marketing
/
European Union
/
Korea
Type of study:
Screening study
Country/Region as subject:
Asia
Language:
English
Journal:
Translational and Clinical Pharmacology
Year:
2016
Type:
Article
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