SCENARIO PLANNING FOR INDONESIAN FDA IN FACING FUTURE CHALLENGES OF THE ENFORCEMENT OF GOOD MANUFACTURING PRACTICE GUIDELINE FOR TRADITIONAL MEDICINE
The continuity of a Drug NRA as PIC/S member is determined by the equality of their GMP Guideline with PIC/S’s. GMP Guideline for TM currently enforced in Indonesia and harmonized with PIC/S is the 2021 edition. There are significant gaps between GMP Guideline for TM 2021 edition compared to the pre...
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| Format: | Theses |
| Language: | Indonesia |
| Online Access: | https://digilib.itb.ac.id/gdl/view/63514 |
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| Institution: | Institut Teknologi Bandung |
| Language: | Indonesia |
| Summary: | The continuity of a Drug NRA as PIC/S member is determined by the equality of their GMP Guideline with PIC/S’s. GMP Guideline for TM currently enforced in Indonesia and harmonized with PIC/S is the 2021 edition. There are significant gaps between GMP Guideline for TM 2021 edition compared to the previous edition causing future uncertainties for the Indonesian FDA to enforce it. To face uncertainties, the scenario planning approach by Garvin and Levesque is utilized for the Indonesian FDA through five stages to develop and identified scenario planning components namely key focal issue, driving forces, critical uncertainties, scenarios, implications and options, and early warning signals. It challenges the Indonesian FDA to perform actions that have never been done before to plan strategies to face the uncertainties in the future regarding the enforcement of the implementation of GMP Guidelines for TM 2021 edition to IOT and IEBA in the next five years. |
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