Identification of Medical Products (IDMP) has been harmonizing data globally across the drug development lifecycle since 2003. At its core, IDMP uniquely identifies pharmaceutical products and standardizes product information using five international ISO standards to maintain global compliance. For strategic pharmaceutical companies, IDMP can be leveraged beyond that to act as an information and data tool to drive additional value.
We will explore what IDMP is, how it has evolved, and what considerations should be made to be successful in your implementation.
The Evolution of IDMP
IDMP began as part of the ICH M5 draft guidance in 2003. The original purpose of the ICH M5 was the standardization of medicinal product identifiers and related terminology to “harmonize product information that would facilitate the electronic exchange of individual case safety reports (ICSRs) within and across ICH regions using the ICH E2B format in post-marketing pharmacovigilance.”
In laymen’s terms—under IDMP regulations, all pharmaceutical and biotech companies are required to electronically submit and maintain detailed product data for all products marketed in Europe.
Between 2003 and 2007, the ICH M5 released updates to include medicinal product identifiers, lists of controlled vocabularies for routes of administration and units of measurement, and electronic specifications that would “enable wider interoperability across regulatory and healthcare communities.” The M5 draft guideline was submitted to the International Organization for Standardization (ISO) in February 2007.
Several standards development organizations (SDOs) took part in a joint initiative with ICH, including Health Level 7 (HL7), culminating in five international standards for IDMP being finalized and published by ISO in November of 2012.
The five standards for IDMP are:
- Medicinal Product ID (MPID)
- Pharmaceutical Product ID (PhPID)
- Substances
- Dosage Forms and Routes of Administration
- Units of Measurement
What Is the Purpose of IDMP?
As a result of COVID-19, organizations further recognized the benefits and necessities of interoperability. Interoperability throughout the drug development lifecycle allows global teams to share data and communicate securely, reducing risk and providing global efficiencies. IDMP creates a common language that enables interoperability—not only within an organization but across health authorities and geographies.
The standardization of MPID, PhPID, substances, dosage forms and routes of administration, and units of measurement are all in place to improve patient safety. Installing a global standard is critical for pharmacovigilance and risk analytics. This common language will help health authorities authorize alternative products when there are shortages. Another benefit of IDMP is the reduction of drug shortages. IDMP will improve reporting and tracking of safety issues internationally, and IDMP identifiers will be used to verify packages and batches and for screening counterfeits.
What Considerations Need to be Made When Implementing IDMP?
IDMP continues to be one of the biggest regulatory challenges for companies. Organizations need to make three significant considerations for a successful IDMP implementation. These considerations are:
Consistent Language Across Drug Development Lifecycle
- The goal of IDMP is to enforce a common language, so you need to speak that language across the entire drug development lifecycle. To succeed, organizations need to identify the data that requires IDMP compliance and connect these data sources to an interoperable IDMP solution.
Decrease Margin of Error with Automation
- With new data-based regulatory requirements coming, the margin for error in reporting will narrow. Automated reporting systems can reduce spelling errors, missing content, correct medicinal naming, and so on. These touchpoints may seem small, but they ensure a foolproof IDMP strategy in the long run.
Keep your IDMP Adaptable to Future Standards
- IDMP is designed to be a global standard, so more geographies will likely adopt an IDMP framework like the EMA. As organizations evaluate IDMP solutions, they must consider the solution’s flexibility to adapt to and adopt future standards and compliance needs like xEVMPD, UDI, and SCL.
How Can You Be Successful with IDMP?
It’s simple: prepare early. The EMA is still targeting 2023 to release their IDMP requirements. In that time, you can begin to identify your source data and make the required connections to your IDMP solution. Many organizations will rely on their existing Regulatory Information Management systems (RIM) to keep them compliant, but keep in mind that not all RIM systems are equipped to handle IDMP. Thankfully, there are standalone solutions available to integrate with existing RIM systems or custom solutions.
Are you interested in taking the first steps toward IDMP readiness?
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