IDMP Standards: Insights and Capabilities to Ensure IDMP Compliance

IDMP compliance, whether it's for UCSF IDMP, EU IDMP, or FDA IDMP, requires comprehensive solutions tailored to your organization's unique needs. At Navitas Life Sciences, we specialize in providing expert guidance and support to ensure seamless adherence to IDMP standards and guidelines. Our solutions encompass every aspect of IDMP compliance, including readiness assessments to evaluate your organization's preparedness, implementation strategies to address any gaps, and ongoing support to maintain compliance. We understand the importance of pharmacovigilance in IDMP compliance, ensuring that your processes align with regulatory requirements for drug safety and surveillance. Partner with Navitas Life Sciences to guide you through the complexities of IDMP compliance, empowering your organization to manage evolving regulatory landscapes with confidence.

What is IDMP?

To ensure international harmonization of specifications for identifying and describing medicinal products, a series of five EN/ISO international standards have been established. The Identification of Medicinal Products (IDMP) standards serve as foundational guidelines for uniquely identifying medicinal products, facilitating seamless regulatory operations such as product development, registration, and lifecycle management, as well as pharmacovigilance and risk management.

What is IDMP compliance?

The primary aim of the IDMP standards is to facilitate the exchange of medicinal product information consistently and robustly across regulatory jurisdictions.

What are the IDMP Standards?

The 5 IDMP standards are:

EN ISO 11238 (Substance Identification) – This standard delineates substances based on their general, main, and specified characteristics, while also accommodating substances with multiple components.

EN ISO 11239 (Dosage Identification) – This standard establishes criteria for pharmaceutical dosage forms, routes of administration, packaging, and related aspects.

EN ISO 11615 (Medicinal Product Identification [MPID]) – This standard provides clear definitions and identification parameters for medicinal products intended for human use.

EN ISO 11240 (Units of Measurement) – This standard outlines specific rules for the use of measurement units in the context of medicinal products.

EN ISO 11616 (Pharmaceutical Product Identification [PhPID]) – This standard uniquely identifies generic medicinal products at various elemental levels, facilitating precise identification across the pharmaceutical landscape.

Navitas Life Sciences’ Support for IDMP Compliance

In the rapidly evolving landscape of pharmaceuticals, ensuring accurate and standardized data management is of paramount importance. The implementation of IDMP has emerged as a significant regulatory initiative, poised to revolutionize the industry's data management practices. As a consultancy offering comprehensive IDMP services, we are committed to guiding our clients through this transformative process, enabling them to harness the full potential of IDMP compliance.

Our Expertise:: In IDMP implementation, Navitas Life Sciences brings deep expertise and experience to support the clients in navigating this complex regulatory landscape. The team comprises highly skilled professionals with a deep understanding of pharmaceutical data management, regulatory requirements regarding publishing and submissions for all markets, pharmacovigilance activities, supporting more than 200 customers. Navitas offers a range of services tailored to meet the client’s unique needs and also ensures a seamless transition to IDMP compliance.

Why Choose Navitas Life Sciences for IDMP Implementation:

i. Gap Analysis and Readiness Assessment: We conduct a comprehensive evaluation of our clients' existing systems, processes, and data structures to identify gaps and assess their readiness for IDMP compliance. This analysis serves as the foundation for developing a customized implementation strategy.

ii. Implementation Roadmap and Strategy: Based on the gap analysis, we create a detailed roadmap and strategy that outlines the steps, timelines, and resources required for successful IDMP implementation. Our approach focuses on minimizing disruption to ongoing operations while ensuring compliance with regulatory mandates.

iii. Data Management and Standardization: We provide guidance and support in establishing robust data management practices aligned with IDMP standards. Our experts collaborate with clients to harmonize data across various domains, ensuring consistency, accuracy, and completeness.

iv. System Integration and Technology Solutions: We assist our clients in selecting, implementing, and integrating suitable software solutions to manage their IDMP data efficiently. We work closely with vendors and technology partners to ensure seamless integration and maximize the value of existing systems.

v. Change Management and Training: A successful IDMP implementation requires effective change management. We develop comprehensive change management strategies and provide training programs to help clients navigate the cultural and organizational shifts associated with IDMP compliance.

vi. Regulatory Reporting and Submissions: We support our clients in generating and submitting the required regulatory reports and submissions in compliance with IDMP standards. Our experts ensure that all necessary data elements are accurately compiled, facilitating efficient interactions with regulatory authorities.

Benefits of IDMP Implementation

By partnering with us for IDMP implementation, clients can unlock a myriad of benefits:

i. Regulatory Compliance: Achieving IDMP compliance ensures regulatory alignment and reduces the risk of non-compliance penalties or delays in product approvals.

ii. Streamlined Operations: Harmonizing data and adopting robust data management practices increase operational efficiency, enabling faster product registrations and improved supply chain management.

iii. Improved Decision-Making: Standardized data sets and integrated systems provide stakeholders with access to accurate, reliable, and real-time information, facilitating informed decision-making and strategic planning.

iv. Competitive Advantage: Organizations that proactively embrace IDMP compliance can gain a competitive edge by demonstrating their commitment to quality, safety, and regulatory compliance.

v. Enhanced Patient Safety: Accurate and standardized data management improves pharmacovigilance and traceability, leading to improved patient safety and regulatory oversight.

Technology to be used for IDMP compliance.

IDMP data can come from many sources in the regulatory ecosystem, whereas Navitas Life Sciences’ rimREADY application can be used for regulatory information management, and the same can be used as a starting source for IDMP.

There are two applications available with Navitas Life Sciences that are used for regulatory data management purposes.

• rimREADY
• idmpREADY

rimREADY

• rimREADY captures Pharmaceutical Product Information (Route of Administration, Strength etc.), Drug Substance, Dossier Approval, MAH, Manufacturing and Packaging Information, HA Correspondences (Query, Commitments).
• rimREADY has third party integration with SPORIFY for EMA SPOR data synchronization.

idmpREADY

• Navitas has idmpREADY application for Data Governance (Data Extraction, Data Management).
• Easy Integration with other business processes systems like DMS, eCTD, QMS, ERP.

idmpREADY Implementation and Communication with Clients:

idmpREADY Model for successful implementation

• The basic set-up for idmpREADY is complete, and implementation will be swift once IDMP becomes effective as per agency regulations, given Navitas Life Sciences' expertise in safety and quality domains.
• Upon IDMP implementation, all necessary data will seamlessly transition from rimREADY to idmpREADY, facilitating XML generation for submission to Eudravigilance.
• A dedicated template for system migration of legacy data is available, which will assist clients in accessing the idmp tool and liaising with Navitas Life Sciences for data migration.
• In addition to the template, Navitas Life Sciences employs technology experts who can provide support and guidance to clients in understanding the idmpREADY process.
• Navitas Life Sciences possesses the expertise to assess data received from clients or transferred from the rimREADY tool before submission to Health Authorities.

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