What Is A Drug Shortage? First EU Definition Due This Month
Efforts to harmonize the notification and communication requirements for drug shortages in the EU will take a step forward this month when regulators adopt a common definition of a shortage together with a number of guidance documents. The situation with regard to drug shortages has been called a public health emergency.
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The EMA has produced two guidance documents on how sponsors should identify, notify and address medicines shortages, and how regulatory authorities should communicate information on shortages to the public and health care professionals.
The EU pharmaceutical industry has highlighted key aspects that it wants regulators to address when it comes to defining the term "drug shortages."
Regulatory bodies from Australia, Canada and the UK say a new pilot program will reduce the need for multiple inspections of the same site, while an MoU signed by Australia and Canada will cut the amount of documentary evidence required from drug sponsors seeking GMP clearances.