The Korea Institute of Drug Safety and Risk Management (KIDS) is a prominent governmental organization based in South Korea. Its operations primarily focus on ensuring the safety and efficacy of pharmaceutical products marketed within the country. Established to uphold stringent standards of drug safety, KIDS plays a vital role in determining various aspects of pharmaceutical regulations, research, and policy formulation.
Some of the key functions of KIDS include:
- Collection and Management of Drug Safety Information: KIDS is responsible for gathering, organizing, analyzing, and assessing diverse drug safety data, including “drug safety information” such as side effects, permissions, and notifications.
- A Corporate Structure Focusing on Asset Management: KIDS operates as a structured corporation with executive officers and staff, and it oversees asset management and resource allocation.
- Adverse Event Reporting: KIDS is responsible for reporting suspected adverse events related to pharmaceuticals, as well as cases related to issues of safety and efficacy, to the Minister of Food and Drug Safety.
- Document Preservation: KIDS maintains records, raw data, protocols, and evaluation results of Post-marketing Surveillance (PMS) activities for a specified duration.
- Investigation, Research, and Education: KIDS conducts studies, educational programs, and promotions to enhance the development and utilization of pharmaceutical safety information.
- Compliance with Legal Duties: KIDS undertakes other legal tasks assigned under the Pharmaceutical Affairs Act or other relevant laws and regulations.
- Utilization of Funds: KIDS is responsible for deploying government contributions, non-governmental donations, and profits for operational purposes.
- Annual Business Planning and Budgeting: KIDS drafts and gains approval for a comprehensive business plan and budget for each fiscal year in accordance with the prescribed regulations.
- International Collaboration: KIDS collaborates with foreign governments, international organizations, and research institutes to advance Regulatory science and innovation.
- Assurance of Confidentiality: KIDS is responsible for ensuring the confidentiality of sensitive information acquired in the course of executives’ and employees’ duties.
- Name Protection and Exclusivity: KIDS prohibits unauthorized use of names that are similar to its own name, thus barring any entity other than the Pharmaceutical Safety Management Agency from using its name or a similar name.
The above functions enable KIDS to manage drug safety information and contribute to the overall safety of pharmaceuticals in South Korea in an efficient and systematic manner.
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