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Identification of Medicinal Products (IDMP) – The Perspective of US FDA & EMA

Identification of Medicinal Products (IDMP) – The Perspective of US FDA & EMA

IDMP is a progression of five specific guidelines established by the International Organization for Standardization (ISO) that emphasize different identification standards in the pharma industry. These standards establish an internationally recognized framework for uniquely identifying and describing pharmaceutical items, as well as for standardized documentation, coding and product information interchange across global regulators, manufacturers, suppliers and distributors.

The IDMP standards were developed in response to a need to standardize the definition of medical product and substance information to simplify their unique identification and exchange in the context of pharmacovigilance.

Under the IDMP guidelines, all pharmaceutical and biotechnology businesses will be expected to report and preserve full product data electronically for all of their goods marketed in Europe. With the ultimate goal of increasing patient safety, IDMP regulation intends to uniquely identify pharmaceutical goods, standardize product information and facilitate information exchange between pharmaceutical businesses and global authorities. The following are the five standards of the basis for IDMP:

  • Medicinal Product Identification (MPID)
  • Pharmaceutical Product Identification (Ph.sPID)
  • Substance Identification (SubID)
  • Dosage Form and Route of Administration
  • Unit of Measurement (UoM)

The Potential Utility of IDMP

From development until marketing authorization, the IDMP is responsible for the central collecting and processing of all essential information on medicinal goods. This regulatory compliance program, led by the European Medicines Agency (EMA), is based on a collection of five worldwide ISO standards that specify an IDMP data model consisting of data elements and their accompanying connections for information interchange and medicinal product identification.

The creation of unique identifiers for medicinal products allows patients, pharmaceutical companies, stakeholders and regulatory activities to keep track of each pharmaceutical product throughout its lifecycle, resulting in greater transparency for patients, pharmaceutical companies, stakeholders and regulatory activities. Other regulatory authorities throughout the world have backed the idea, including the US Food and Drug Administration (FDA), Health Canada and China’s National Medical Products Administration (NMPA).

Implementation of IDMP by EMA & US FDA

Throughout the project lifecycle, an acceptable approach for implementing IDMP was created and adapted. The method combines data governance with the development and deployment of technology solutions and tools, as well as the adaptation and improvement of existing business processes.

Data quality, granularity, availability and accessibility must be explored for all data, systems and processes that provide data for IDMP submission. The creation of various technical solutions supports the collecting and integration of data from diverse data sources into their “golden source(s)” destination, as well as harmonizing data of various formats and naming conventions into coherent data sets.

For successful implementation of such a project with benefits in addition to compliance, tight integration of these tools, as well as strong general and change management abilities mixed with subject matter expertise, are required.

Impact of IDMP in the Pharma Industry

Although IDMP is tied in with recognizing meds and their constituent substances and assembling points of interest and doesn’t cover the clinical adequacy of an item, the capacity to quickly figure out where items were made, the batch they came from, the specific ingredients and more would assume an urgent part in checking, dealing with any incidental effects and supporting administrative & regulatory prevention and interventions. IDMP can also aid in the discovery of new clinical trials, as well as the tracking of the composition and indications of newly developed products.

It became evident that global data standards can help with the pharmacovigilance aspect of safely introducing new vaccines to the market. The ISO IDMP standards, which Europe is close to implementing under the EMA SPOR initiative, will go a long way toward making data-driven regulatory filings more efficient, giving the pharma industry the following beneficial outcomes:

  • Consistency in constituent Data

The goal of IDMP standards is to consistently identify medicines and their ingredients. They let manufacturers and health organizations share standard manufacturing data, which aids in the monitoring of side effects and the implementation of regulatory actions.

  • Move Beyond Compliance

In the response of COVID-19, there was a potential need for standardized data and this put IDMP to real use for the pharma industry. As it is viewed by pharma companies till now, that compliance regulations are a burden, IDMP makes it compulsory for them to introduce their products in the market and following the regulations mandatorily.

  • Support in Business Processes

From clinical trial clearances to shortage management to product serialization and tracking, IDMP requires standards-based master data about products that could assist facilitate a variety of interactions between industry and authorities.

Technology Companies reacting to IDMP tools development

The main goal for medical and pharmaceutical firms when implementing the IDMP is to guarantee that the data is correct, comprehensive and clean, that it is useful and that it is valuable to the company. Companies will be on shaky ground if they don’t have that solid foundation. The output will always be as good as the original content, whether the latter application is an IDMP submission or something more operational and internal.

So, how can businesses move ahead and make this work in their favor? They cannot, however, cut corners; otherwise, their efforts will be for naught. They can, however, use automation if they understand the task and select the appropriate tools. The rest is just a charade for the time being. It is far too early to create a magic database that businesses can use to submit to the IDMP. In any case, compared to the work that needs to be done today, that final-stage effort of definition refining and submission will be rather easy.

So, concluding to all the challenges and requirements of the pharma industry related to the IDMP guidelines, technology companies are focused on developing a solution that can help them in quickly comparing the content of similar documents from numerous sources in huge batches, compile it into a single central database and make it easier fetch, account for, cross-check and label products resulting in getting to the necessary stage of getting the company’s product data assets in order.

Conclusion

Certain components of the regulatory role will be automated, allowing for a shift in focus to more strategic work while operational responsibilities are gradually reduced. This effectively transforms IDMP into a data and information management project with benefits that go beyond compliance, demonstrating how a pharmaceutical business may turn a compliance project into a strategic effort.

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