DRUG REGULATORY AFFAIRS INTERNATIONAL
The pharma sector must comply with IDMP standards in the EU region starting July 2016. This provides regulators with the means of easily comparing product data across regions and with different manufacturers.
Over the last couple of years the European Health Authorities in conjunction with the International Standards Organization (ISO) have been developing a set of global data standards referred to as Identification of Medicinal Products (IDMP).
The Identification of Medicinal Products (IDMP) standards were developed in response to a worldwide demand for internally harmonized specifications for medicinal products. The EU is the first to implement these standards, and the other ICH regions will follow. The pharma sector must comply with IDMP standards in the EU region starting July 2016. Following the EU, the other ICH (International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use) countries will then begin their own adoption processes…
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