ISO IDMP is going into effect and many challenges come with this regulatory change
The global pharmaceutical industry and its regulators are on an ambitious journey. Their target is for no fewer than five ISO standards (11238, 11239, 11240, 11615, and 11616). The legislation which began in 2016 is designed to standardize the identification of medicinal products. This will greatly improve pharmacovigilance across entire jurisdictions and reduce counterfeiting, ultimately keeping patients safer.

ISO 11238 provides a framework for structuring substance information (SSI) and is probably the most complex of the five standards. This is because it requires the submission of all regulatory activities related to the active ingredients, substances, excipients, packaging material, development, registration and the life cycle management of medicinal products to ensure compliance.

Since this amount of information is typically scattered across multiple business areas, it is vital that all life sciences companies ensure involvement through their complete line of business. This can require a huge amount of effort to structure and align data, systems and documents while not jeopardizing data security, solidity or costs during implementation.