The pharmaceutical industry including its operations and associated functions run on data and content. Whether it is safety, regulatory, or clinical data, the pharmaceutical industry and all its stakeholders are actively involved in collecting, monitoring, evaluating, and exchanging crucial information. Indeed, the need for standardization of medicinal product information was highlighted in order to facilitate identification and exchange of information for safety and regulatory activities. Thus, the International Organization for Standardization (ISO) Identification of Marketing Products (IDMP) emerged with the aim to facilitate and maintain consistent, robust, and reliable medical information exchange between key stakeholders. But what are the pharmaceutical organizations’ approach towards maintaining compliance with the IDMP standards?
What constitutes the Identification of Marketing Products?
Identification of Medicinal Products (IDMP) is a global standard for identifying, documenting, and exchanging information on medicinal products that constitutes five ISO standards. These standards have been created to synchronise requirements for the identification and description of pharmaceuticals on a global scale:
- ISO 11615 – (Medicinal Product Identification) – Standard for identifying and exchanging regulated medicinal product information.
- ISO 11616 – (Pharmaceutical Product Identification) – Standard for identifying and exchanging regulated pharmaceutical product information.
- ISO 11238 – (Substance Identification) – Standard for identifying and exchanging regulated information on substances that are used medicinally.
- ISO 11239 – (Dosage Form & Route of Administration) – Standard for identifying and exchanging regulated information on dosage forms, unites, administration routes, and packaging for pharmaceuticals.
- ISO 11240 – (Units of Measurement)- Standard for identifying and exchanging units of measurement.
IDMP aims to enable reliable and consistent transmission of information about pharmaceutical products. It can be applied to pharmacovigilance, regulatory submissions, clinical trials, and GMP inspections. The standardised information provided by IDMP can improve communication and collaboration among stakeholders, resulting in more efficient regulatory processes, reducing errors, and helping ensure the quality and safety of medicinal products.
EMA was the first agency to mandate ISO IDMP compliance requiring pharmaceutical companies to submit product information in the IDMP format by the end of the first quarter of 2023. EMA approached ISO IDMP implementation in a phased manner that is based on 4 major regulatory data domains: substance management services (SMS), product management service (PMS), organization management service (OMS), and referential management service (RMS), or (SPOR). The first phase focused on RMS & OMS that provide the foundation for PMS and SMS delivery. In 2022, EMA released the latest version of the IDMP-SPOR implementation guideline v2.1.1 which addressed certain gaps regarding definitions of product data for manufacturers that would help align data with the electronic application form for human variations, and other clarifications. EMA also set out methods to migrate the data for centrally authorised products (CAPs) from the internal corporate system to the emerging SPOR PMS. Furthermore, information on post-Brexit cases for submitting data for products that are authorised in Northern Ireland are also included.
The US FDA followed soon and, more recently, published a guidance document on the ‘Identification of Medicinal Products- Implementation and Use’ in March 2023 for applicants, registrants, and sponsors that are actively involved in regulatory submission for pharmaceutical product data.
Adapting to the IDMP standard- a golden opportunity for pharma companies
IDMP aims to enhance patient safety by standardising the way medicinal product information is recorded and exchanged between regulatory authorities, manufacturers, and healthcare professionals. Organizations have their own way of collecting and managing data using their own systems, but these are often siloed and disconnected with data sources in unstructured formats. Hence, the need to enhance compliance with the IDMP standard may put organizations ahead of the market. Due to the enormity of the IDMP, organizations should implement the standard in order to comply with regulatory requirements and more robust data exchange for patient safety. It provides the golden opportunity for organizations to transform the ways in which they manage data, business, and IT systems.
How should companies approach IDMP implementation?
It is important to understand where the data within an organization is stored. This can be identified by conducted a gap-analysis to determine the organization’s status of data and detect any gaps that need to be filled in order to achieve compliance. The data elements can be related to medicinal product name, clinical particulars, marketing authorizations, pharmaceutical products (i.e., administration route, strength), packaging, manufacturing, and more.
Despite data being available in unstructured format, majority of the required data can be obtained from documents that have been used for pharmaceutical product registration i.e., MA application form, SPC, CTAs, IBs, eCTD modules etc). Inevitably, this data is relatively extensive. Often medicinal product data is found to be incomplete or is not obtained at the level of granularity that is required. Furthermore, some IDMP data tend to be stored in the organization’s system rather than regulatory documents (RIMS, Aggregate reports, and even external manufacturing & packaging systems).
Organizations will need to check all the data that is stored in their systems in order to confirm that is it is complete and consistent before any submissions. After the gaps have been identified, a comprehensive roadmap will have to be generated, capturing the organization’s current status as well as elaborating next strategic steps are in order to bridge these gaps and obtain compliance. These could be to harmonize and standardize IDMP data elements from relevant sources, for example.
The implementation of IDMP can aid in enhancing patient safety, streamlining regulatory processes, enhancing pharmacovigilance, improving supply chain management, and data management and interoperability. The regulatory framework supports the exchange of standardize pharmaceutical product information and its identification. These benefits can ultimately lead to better public health outcomes and improved access to safe and effective medicinal products across the world. Organizations must submit comprehensive information about their products which is then stored in a centralized database to facilitate better and efficient collaboration and data exchange between key stakeholders. Organizations are advised to conduct the necessary operations in order to maintain compliance with IDMP standards and stay ahead of the regulatory landscape.
References and Further Reading
- US FDA. Identification of Medicinal Products (IDMP). 2022
- Data on medicines (ISO IDMP standards). 2022
- Substance, product, organisation and referential (SPOR) master data. 2022
- US FDA. Identification of Medicinal Products- Implementation and Use. 2023
- TOPRA. EMAs IDMP-SPOR Implementation Guideline v2.1.1. 2023