Malaysia, Singapore Join Hands On Review Of Generic Drugs
The National Pharmaceutical Regulatory Agency and the Health Sciences Authority have announced a pilot to kick-off their new initiative on the simultaneous assessment of new generic drugs.
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A technical workshop is planned for later this year to identify common “use cases” for real-world evidence that are important to the European Medicines Agency, health technology assessment bodies and payers.
The EU’s conditional approval of four COVID-19 vaccines and its decision to extend the use of Pfizer/BioNTech’s Comirnaty to a younger age group were challenged in the court last year but the cases were declared inadmissible.