Identification of medicinal products, commonly known as IDMP, is a series of standards being put into place by the European Medicines Association to ensure that pharmaceutical companies have an international framework to identify and describe medicinal products they’re releasing on the market.
The standards were announced more than a decade ago, but their implementation has been delayed for a number of years. With implementation now on the horizon, industry orgs are looking at how to use IDMP standards to improve efficiencies in data and product lifecycle management (PLM).
“You can look at the regulations as something that impedes you or as something that can make your business more effective,” says John McCarthy. “What the pharma industry has started to realize is that they’re collecting the data that goes into IDMP early on, but it’s very fragmented. … With our PLM capabilities, combined with our science and lab capabilities, you’re able to follow the drug or trace the treatment through its complete lifecycle.”
With the 3DEXPERIENCE platform, there’s seamless integration of all the information – from identifying and formulating active ingredients and packaging to shelf storage and home administration of treatments – so companies can deliver innovative products with confidence that strict regulatory standards are being met. “We can keep track throughout the process to build up a digital thread and support digital continuity across the organization,” McCarthy explained.
What is IDMP in pharma?
IDMP is an international patient safety initiative addressing the need for a global identification system for managing regulated pharmaceutical products during their lifecycle. According to US Food and Drug Administration, the five standards are:
- Medicinal Product Identification (MPID): This includes details like product names, clinical particulars, medicinal product packaging, marketing authorization and more.
- Pharmaceutical Product Identification (PhPID): This standard associates medical products with similar pharmaceutical composition.
- Substance Identification (SubID): This standard defines “substances that constitute a medicinal product by their main, general characteristics.”
- Dosage Form and Route of Administration: This standard covers identification and exchange of regulated info on pharmaceutical dose forms, units of presentation, packaging and routes of administration.
- Units of Measurement (UoM): This standard deals with defining requirements for representing units of measurement in coded form and provides structure for different unit vocabularies and language translations.
Compliance requires pharmaceutical identifiers to be sent to regulatory agencies in a specific format for each language and country and tagged with an ISO (International Organization for Standardization) code.
What are the objectives of IDMP?
By standardizing definitions of medicinal productsand pharmaceutical identifiers,IDMP facilitates the global exchange of data among regulators, manufacturers, suppliers and distributors and improves transparency and the safety of medications throughout the world.
Here’s how it works: Data is captured in standard formats or common formats, so it can be shared among people who are, for example, deciding how to formulate the active ingredient in a pill or injectable. Then, they’ll determine what else needs to be added to the product so a patient can actually take it. Next comes figuring out packaging and route of administration.
“We’re continuously adding information to that drug as it goes through its lifecycle,” said McCarthy. “We decorate it with more and more information as we learn about it through its development cycle.”
What is the international standard of medicinal products?
IDMP is not only about submission of information across the domains of regulatory, pharmacovigilance and manufacturing, it also requires pharmaceutical companies to provide transparency across the entire lifecycle of their medicinal products. By meeting these standards, manufacturers improve accuracy and consistency in the international exchange of medicinal product information. The adoption of these standards is a step in managing complexity of medicinal and pharmaceutical products.
What are the benefits of IDMP?
As the pharmaceutical industry has become increasingly global and complex, these regulations will improve patient safety, provide greater transparency and better secure the pharmaceutical supply chain. By adopting a common slate of IDMP standards, best practices will accelerate across the industry. The data collection required for IDMP compliance creates an opportunity to build an up-to-date, consolidated collection of medicinal product data. Single definitions for products can facilitate the flow of knowledge through organizations and throughout the industry.
Unambiguous global identification will:
- Improve pharmacovigilance with improved safety monitoring
- Create opportunity to communicate and build trust with the public and other stakeholders about medicinal product quality and safety
- Identify pharmaceutically equivalent products across regions, to support mitigation of drug shortages and
- Support the exchange of medicinal product information between companies and regulators.
For regulators, McCarthy explained, a key benefit in the case of an adverse event, is quickly identifying the cause and how to trace it backward. “For pharma companies, one of the benefits is being able to ask questions of the data that you couldn’t ask before now that you have this digital thread,” he said.
For example, if there’s a change in an ingredient – not the active ingredient – the company uses the digital thread to observe where it is used and what other drugs they make also use that ingredient to determine the impact of a disruption or issue with the ingredient.
“It allows them to ask questions like where am I making this and where can I trace some of the raw materials back to,” McCarthy said. “As they’re looking at new product introductions, they have a large corpus of knowledge, so they could see with drugs similar to this one; I was able to produce it here and in this way. It helps with how you might make a similar drug because you have your arms around this knowledge and know-how.”
What are the challenges of implementing IDMP?
With the advancement of next-generation therapies, scientific discovery, development and manufacturing will continue to become more and more complex. Implementation of IDMP is also complex and poses many challenges for pharmaceutical companies as they strive to meet the standards. Some of the challenges are:
- With fragmented data, collecting and submitting to meet IDMP requirements is time-consuming and resource-intensive.
- Medical products may have different names across health systems, and across countries.
- The same name may identify different products with varying active ingredients.
- Dosage strengths and packaging may vary.
- The number and kind of medicinal products authorized for national marketing differ across countries.
What is Dassault Systèmes’ solution for IDMP?
Collecting medicinal product data requires the creation of a comprehensive product repository, maintained over time, with the agility to manage changes throughout the product lifecycle. Dassault Systèmes addresses these challenges through the 3DEXPERIENCE platform, a business and innovation platform that provides organizations with a holistic, real-time view of their business activities and ecosystem.
The 3DEXPERIENCE platform combines knowledge and know-how using a unified data model to support all disciplines and acts as a single version of the truth. As a unified collaborative environment, the platform brings together all participants and enables secure, real-time collaboration on any device.
What is the advantage we offer?
The 3DEXPERIENCE platform provides a data-driven, model-based approach that enables pharmaceutical companies to innovate in a new digital paradigm rather than just a static paradigm of managing files or documents. With a platform-based approach to the IDMP standard, a digital thread connects every part of the medicinal product, which organizations can harness to improve business operations.
Examples of harnessing this data in the pharmaceutical industry include:
- Assessing the impact of a change in an ingredient due to disruptions in the supply chain
- Answering “where-used” questions across the product and manufacturing network of ingredients, methods and operations
- Easing the burden of creating regulatory filings and documentation
- Applying FAIR (Findable, Accessible, Interoperable, Reusable) data principles to support decisions
- Simplifying tech transfer of product and process information from bench to pilot to commercial scale.
“You want a platform because you want true digital continuity so as you decorate the drug candidate with more and more knowledge and information, you’re doing it on the platform,” McCarthy said. “There is going to be data in other sources. What we can do is reach into those other sources and apply ontologies to provide a truly holistic view of that data regardless of where it is.”
The 3DEXPERIENCE platform provides pharmaceutical companies with the solutions to leverage vast stores of information housed across the enterprise to ensure pharmaceutical companies have the right product, at the right place, at the right time. Delivering collaborative innovation and operational excellence through digital continuity is a core benefit the platform provides. The result is improved commercialization efficiency that enables pharmaceutical companies to focus on delivering truly innovative products that generate real health benefits to patients and economic benefits while reducing IDMP compliance risk.
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Melissa Russell is an award-winning journalist and editor living in the Boston area. She has written for many news outlets as well as for websites, trade publications and other platforms.