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Europe Leads Generic-Drugs Assessment Project
The European Union’s decentralized procedure is to be used by international regulatory agencies as a model for facilitating generic-drug application assessments, as part of the International Generic Drug Regulations Pilot (IGDRP) project.
The European Union’s decentralized procedure is to be used by international regulatory agencies as a model for facilitating generic-drug application assessments, as part of the International Generic Drug Regulations Pilot (IGDRP) project.
At the request of a generic-drug company, the EU will share assessment reports in real time with collaborating international regulatory agencies. According to a European Medicines Agency (EMA) press release, this sharing of information will contribute to facilitating and strengthening the scientific assessment process, enabling drugs to be authorized in different territories in a coordinated fashion at approximately the same time.
The first phase of the pilot project will involve the EU, Australia, Canada, Chinese Taipei and Switzerland. Other members of the IGDRP (e.g., Brazil, China, Japan, Korea, Mexico, New Zealand, Russia, Singapore and South Africa) may decide to take part in the pilot program at a later stage. The European Directorate for the Quality of Medicines & Healthcare (EDQM) and the World Health Organization will observe the project.
Source: European Medicines Agency
Key Findings of the NIAGARA and HIMALAYA Trials
November 8th 2024In this episode of the Pharmaceutical Executive podcast, Shubh Goel, head of immuno-oncology, gastrointestinal tumors, US oncology business unit, AstraZeneca, discusses the findings of the NIAGARA trial in bladder cancer and the significance of the five-year overall survival data from the HIMALAYA trial, particularly the long-term efficacy of the STRIDE regimen for unresectable liver cancer.
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