J Pharmacoepidemiol Risk Manage.  2022 Mar;14(1):19-28. 10.56142/2022.14.1.19.

The Current Status of the Organizations Dedicated to Post-marketing Safety Management of Pharmaceuticals

• Lee SM
• Bae G
• Hyun E
• Song YK

• KMID: 2534670
• DOI: http://doi.org/10.56142/2022.14.1.19

Abstract

Post-marketing safety management systems are important to ensure the safe use of pharmaceuticals. This review analyzed the current status of post-marketing safety management organizations to improve the consistency of its reviews. Analyses were conducted using information provided by the Ministry of Food and Drug Safety of Korea, the United States Food and Drug Administration, the European Medicines Agency, and the Japanese Pharmaceuticals and Medical Devices Agency. A gap analysis was conducted to address the issues related to the organization, and an improvement plan was devised through the strength, weakness, opportunity, and threat analysis. In the United States, the drug risk management plan, pharmacoepidemiologic research data, signal review, medication error analysis, and post-marketing data reviews are conducted by separate departments each comprised of a multidisciplinary expert panel. In the European Union, pharmacovigilance data review and actions based on such reviews are conducted by separate departments; data review is conducted by an expert committee of member countries. Similar to Korea, Japan has risk managers affiliated with both the review and safety management departments. In order to better systematize the management of post-marketing safety, the division of duties among departments should be clarified and a system for reviewing pharmacovigilance data by a multidisciplinary team should be established. In addition, more manpower is needed to meet the increasing demands for post-marketing management.

Keyword

Post-marketing; Safety management; Pharmacovigilance; Organizations; Review system