MFDS Press Release on 16 July 2020 :
To improve the safety management system of post-approval marketed drugs, the current Post-Marketing Safety System based on the ‘Re-Examination System’ (every 4 – 6 years) will be changed to the one based on the full product life-cycled Risk Management Plans (RMPs).
This change is for international harmonization of the safety management system after drug marketing, strengthening of the analysis of collected safety information, enhancing the “drug monitoring”
and establishing a new data protection system.
The Post-Marketing Safety System change will be completed by the end of 2022 in a 3-step plan.
Step 1: (~2020): resolve the duplication of data due to the simultaneous implementation of the risk management plan and re-examination. Improvements to post-marketing safety study regarding number of subjects to be calculated and applied according to the prevalence rate, indications; etc. that matches the characteristics of the drug.
Step 2: (~2021): Strengthening risk management plan efficiency by preparing the legal basis for the’Risk Management Plan’ and clarifying implementation details such as Integration of targets for re-examination and risk management plans, improved procedures/timelines for submitting risk management plans, regular and up-to-date PSUR and more analysis of abnormal cases.
Step 3 (~2022): Achieve international harmonization of the post-marketing safety management system of drugs by unifying the risk management plan for the re-examination system and establishing a separate data protection system. Introduce intensive market monitoring to actively collect drug use information for a certain period of time immediately after marketing for drugs with limited safety information
For more information, please access from the link below:-
의약품 시판 후 안전관리, ‘위해성관리계획’으로 일원화