Vada A. Perkins

	Pharmaceutical regulation is a data-driven environment; it has been undergoing a data revolution due to the speed at which innovative technologies have be applied within the life sciences sector. However, the pace at which innovation can be transitioned into the regulatory framework and applied as regulatory science and technology across the global product lifecycle to support more efficient and effective decision-making requires a rigorous level of assessment and analysis. Some of this process is untested due to lack of precedent. More specifically, the regulatory framework operates at a different speed for a variety of reasons, such as acquiring the appropriate level of intellectual capital within the pharma industry and regulatory agencies, fully understanding the technology in question for applicability and use, and the development and implementation of policy to guide and support implementation.

	Although there are several efforts underway to bridge this divide, ranging from something as basic as mandating the submission of regulatory data in an electronic format to the more complex such as the incorporation of tools to support the submission and use of next-generation sequencing (NGS) data (e.g., FDA-CBER’s High-Performance Integrated Virtual Environment-HIVE). True convergence between the two will not be possible without the introduction of a more agile process for regulatory policy and guidance development and the utilization of data standards to ensure that received data to be analyzed is of the highest quality with minimal data integrity loss. It is important to ensure what is being applied is fit-for-purpose for its intended application while mitigating any risk that would outweigh the potential benefit to better inform regulatory decisions.

	Though it may appear to be fairly straightforward at a strategic level, the complexities of regulatory data are vast and comprehensive given that the global regulatory product lifecycle covers a broad spectrum-from clinical trials through to marketing authorization and postmarketing activities. A logical and foundational starting point would be the ability to uniquely identify medicinal products on a global scale throughout their lifecycle, from the origin of the substance through to unique identification at the individual package level. Currently, Industry and regulatory authorities have their own distinct processes for identifying a medicinal product to support their activities. Then there is the matter of how product information is identified and used downstream by external stakeholders for electronic health and medical records, prescribing, dispensing, supply chain, clinical decision support, and patient registries, among other areas.  For example, the are ongoing initiatives to publicly release vast amounts of clinical and safety data to support better evidence generation on regulated products. The most significant item of importance is robust data quality and integrity, but poor data quality  can cripple even the best analytical techniques and methods, thus limiting utility.

	The International Organization for Standardization (ISO) identification of medicinal products (IDMP) is a suite of standards and corresponding technical specifications for improved identification, data quality, and integrity of medicines throughout the product lifecycle. The implementation of data standards such as IDMP is simply one key step to ensuring that product information is identified and captured accurately within the regulatory framework and beyond. It is not limited to finished products, as it can be applied early in R&D prior to the initiation of the regulatory lifecycle. While the original intent of IDMP as a global standard was to primarily support pharmacovigilance, the concept of uniquely identifying a medicinal product on a global scale has multiple utility to support a variety of regulatory initiatives. Those include establishment identification, product to establishment relationships, lot distribution, supply chain integrity, falsified medicines, and clinical trial registration and results reporting.

	IDMP consists of the five following data standards: 

		ISO 11615, health informatics-Identification of medicinal products-data elements and structures for the unique identification and exchange of regulated medicinal product information.

		ISO 11616, health informatics-Identification of medicinal products-data elements and structures for the unique identification and exchange of regulated pharmaceutical product information.

		ISO 11238, health informatics-Identification of medicinal products-data elements and structures for the unique identification and exchange of regulated information on substances.

		ISO 11239, health informatics-Identification of medicinal products-data elements and structures for the unique identification and exchange of regulated information on pharmaceutical dose forms, units of presentation, routes of administration and packaging.

		ISO 11240, health informatics-Identification of medicinal products-data elements and structures for unique identification and exchange of units of measurement.

		505(b)(2) applications accounted for 63% of 451 original new drug applications approved by the FDA during 2009-15.

	There are four corresponding technical specifications to these standards (see 

). The primary purpose for the development of these standards was in response to a worldwide demand for internationally harmonized specifications for medicinal product identification. IDMP specifies data elements, structures, and relationships, in addition to required terms and definitions. There is a vast amount of information required in a dossier and IDMP is not intended to be the complete solution for all regulatory data represented. However, the ability to uniquely identify a medicinal product and structure this information per these standards allows for consistent implementation throughout the international regulatory framework-to achieve regulatory harmonization and ultimately convergence.  

Vada A. Perkins, Founder and Managing Principal of IDENTIFICA, a global regulatory intelligence and life sciences IT firm specializing in global product lifecycle data management

Articles

The implementation of the International Organization for Standardization identification of medicinal products (IDMP) is a key step to ensuring that information on new innovations are identified and captured accurately within the regulatory framework and beyond.

Vada A. Perkins

Articles

IDMP: An International Standard for Lifecycle Data Management