Tracking a Medicine's Regulatory Risk Management Commitments Provides Better Transparency and Oversight.
Pharmaceutical companies are required to provide Risk Management Plans (RMPs) to support the marketing authorisation of medicines. These RMPs contain information on efficacy and safety, outline risks or gaps in information, and detail commitments for post-authorisation pharmacovigilance (PV) studies...
| Publicado en: | Therapeutic Innovation & Regulatory Science Vol. 59; no. 5; pp. 901 - 909 |
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| Autores principales: | , , , , , |
| Formato: | research tables/charts Journal Article |
| Publicado: |
Springer Nature
Sep2025
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| Acceso en línea: | Ver este registro en EBSCOhost |