PDA Issues Technical Report on Drug Shortages


From DCAT Value Chain Insights (VCI)

By Regulatory News posted 01-12-2015 16:12

  

Drug shortages and supply disruptions are increasingly emerging as a global challenge. As part of the European Medicines Agency's (EMA) initiative on drug shortages, the Parenteral Drug Association (FDAP) participated in a collaborative inter-association drug shortage team to develop solutions to address prevention and communication of drug shortages caused by manufacturing and quality related disruptions.

As a contributor to this inter-association drug shortage initiative,the PDA has developed TR 68: Risk-Based Approach for Prevention and Management of Drug Shortages. This Technical Report is expected to be globally significant as it is the first practical approach to identifying and mitigating drug shortage risks in a structured way, and thus once implemented, it could lead to fewer drug shortages. It has been developed with input and support from the EMA, several EU National Competent Authorities (NCAs) and the US Food and Drug Administration. EMA and European inspectors will be promoting the TR in the European Union as best practice for proactively identifying and managing risks to supply caused by manufacturing and quality issues.

Source: Parenteral Drug Association

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