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."
Members of the European Parliament were told that once the list was out, work would begin on identifying the products most vulnerable to supply chain problems.