Unlocking the value in industry regulations


Pharmaceutical businesses are facing a range of new challenges as they manage information to meet continuously evolving industry regulations

The recently introduced Identification of Medicinal Products (IDMP) standards are designed to support the unique identification and exchange of regulated information. Their ISO-defined data elements and structures, related to substances, dosage forms and units of measurement, should go some way to address fundamental ambiguities concerning how medicines are packaged, marketed, sold, dosed and consumed in different countries.

GS1 standards are also being adopted as a way to share consistent and accurate product information, and even more new legislation is not far off. The EU Falsified Medicines Directive is set to be implemented by 2019, and this will require additional safety features on packaging, including GS1 barcodes to support product authentication.

Meeting the requirements of these regulations will undoubtedly be complex, but businesses should consider ways in which they can take advantage of their implementation and how they could be used to add value to existing business processes and the development of customer relationships.

Although IDMP standards, for instance, are used to facilitate the exchange and tracing of information between regulators and different organisations, they could also be used as an effective way to disseminate information between departments within a business.

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