However, it does not deliver a comprehensive view of the overall manufacturing control strategy or a means of understanding and managing the quality of the product throughout its life cycle. The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guideline on Registration of Pharmaceuticals for Human Use (M4) offers advantages in the consistent format of the registration dossier using the Common Technical Document (CTD). Such requirements could spread beyond these two countries, especially because risk management for product availability is included in the revision of the ICH Q9(R1) guideline “Quality Risk Management.” To further minimize drug shortages, regulators in the United States and France recently established requirements for risk management on drug shortages avoidance. Many regulators have instituted requirements for reporting potential or actual drug shortages. Such requirements could spread beyond these two countries, especially because risk management for product availability is included in the revision of the ICH Q9(R1) guideline “Quality Risk Management.” Shortages of essential medicines around the world have been an ongoing concern for patients, caregivers, and regulators and have been exacerbated by the COVID-19 pandemic. Regulatory Trends & Quality Initiatives - Shortages of essential medicines around the world have been an ongoing concern for patients, caregivers, and regulators and have been exacerbated by the COVID-19 pandemic.
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