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How regulatory professionals can apply the RAPS Code of Ethics to
current and future endemic disease outbreaks characterized by a rapidly
developing healthcare situation and quickly evolving knowledge base
regarding prevention, treatment and potential cures.
Earlier this week, the House Energy and Commerce Committee released a draft of an ambitious new bill, the 21st Century Cures Act. The legislation, if enacted, would radically alter the way in which drugs and devices are regulated in the US. Within the 393-page legislation are dozens and dozens of proposals, large and small. But which ones are especially worth paying attention to? We're glad you asked. What follows is our analysis of which proposals are likely to attract the most attention—and controversy—in the coming months.
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
South Africa’s pharmaceutical regulating body, the Medicines Control Council (MCC), is
staffed to review a dossier completely to international standards, and it conducts its own review of the complete
dossier, regardless of other major regulatory approvals. In the last
decade, limited resources have meant increased review timelines. To ensure a
timely and successful application, it is crucial for pharmaceutical companies
to facilitate open discussions and exchange information with key MCC regulators,