ISSN 0377-9556 (PRINT)
ISSN 2383-9457 (ONLINE)
ISSN 2383-9457 (ONLINE)
Lists to be prepared by national institutions for utilizing RWD/RWE in regulatory decision making
| Lists to be prepared | Contents |
|---|---|
| 1. Development of RWD/RWE usage guidelines | • RWD definition and access - Definition of RWD - Certified RWD type |
| • RWD collection - Standardization measures - Quality management standards |
|
| • RWE production - Criteria for securing transparency and reliability |
|
| • Including differential criteria according to the type of regulatory decision-making - RWD/RWE utilization procedure |
|
| 2. Expansion of RWD types and improvement of accessibility | • Developing and publishing certified RWD catalogs |
| • Establishment of public data network system including certified RWD | |
| • Preparation of personal information linkage between RWD | |
| • Continuous authentication of new type of RWD | |
| • Relaxation of limited access to RWD | |
| 3. Expansion of RWD/RWE experts | • Expansion of manpower to review contents related to RWD/RWE |
| 4. Investigating foreign RWD/RWE use cases | • Discovering cases where RWD/RWE are used in regulatory decision making abroad and publishing casebooks |
| 5. Conducting research using domestic RWD/RWE and sharing the results | • Specifying the cases where domestic RWD/RWE are necessary for regulatory decision making and sharing the research process and results for high feasibility |
| 6. Establishing a forum for communication between RWD/RWE stakeholders | • Collaboration between national institutions and establishing cooperative institutional platoforms |
| • Providing a platform for communication between stakeholders | |
| • Promoting RWD/RWE utilization results and preparing reporting rules for the public |