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  • Regulatory NewsRegulatory News

    ISO: Identification of Medicinal Products Standards Revised

    The International Organization for Standardization (ISO) is revising a series of standards known as Identification of Medicinal Products (IDMP) standards as part of an effort to simplify the exchange of medicinal product information. "When regulators adopt IDMP, their capacity to interoperate with each other makes for safer patient care; this is, for example, a huge benefit for adverse-event reporting and for documenting medication in patient records," Christian Hay...
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    Identification of Medicinal Products (IDMP) Standards Part 4: Technical Approaches to IDMP

    This article discusses IT approaches to support a gap analysis and implementation of the upcoming Identification of Medicinal Products (IDMP) standards with regard to generating, collecting and mapping accurate and correct data prior to submission in an effort to prevent delays in a product reaching the market. This is the final installment in a four-part series on the IDMP standards and their respective implementation guidelines. 1-10 The first three articles explained...
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    Identification of Medicinal Products (IDMP) Standards Part 2: The Implementation Roadmap

    This is part two of a series on the Identification of Medicinal Products (IDMP) standards and their respective implementation guidelines. 1-9 Part two reports on current IDMP activities and provides the plans and timelines in the IDMP implementation process. Part one 10 presented the reasons for the new standard, the driving forces behind IDMP and the concepts behind the standard. Current Status of ISO Activities A new version of the International Organization for...
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    Identification of Medicinal Products (IDMP) Standards Part 1: Impact on the Regulatory World

    This is part one of a four-part series on the Identification of Medicinal Products (IDMP) standards and their respective implementation guidelines. 1-9 This segment reviews the steps needed to prepare for their global implementation and offers technical solution options for the industry. Why IDMP? Despite clear progress in the development of increasingly specific and complex drugs, health authorities worldwide say they have observed a steady and alarming increase in ...
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    ISO IDMP: Another Compliance Project or a new way of Conducting Business?

    This article discusses Identification of Medicinal Products (IDMP) as a new way of conducting business, the benefits gained by adopting the IDMP model and how IDMP can be implemented to help businesses run more efficiently. To support the continuous improvement of pharmacovigilance oversight within the EU, the European Commission (2012) has mandated pharmaceutical companies to submit product information according to ISO IDMP standards. 1 The standards are global and o...
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    Bringing Structure to Substance Information

    This article discusses compliance challenges pharmaceutical companies face with the International Organization for Standardization (ISO) Identification of Medicinal Products (IDMP) standard for structured substance information. To support continuous pharmacovigilance oversight improvement within the EU, the European Commission has mandated pharmaceutical companies’ adherence to ISO IDMP standards by 1 July 2016 . 1 These standards collectively outline the data ...
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    Going Digital: EMA to Ditch Paper, Require Electronic Application Forms

    In an effort to reduce its administrative burden, the European Medicines Agency (EMA) will soon require companies to use electronic forms for a number of application types. The move is part of a wider effort in the EU to transition to international and electronic standards. Going Digital The process of transitioning to electronic systems can be complicated, especially for regulatory processes which are often highly complex.  However, electronic documents provide a num...
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    EU Task Force to Implement New Drug Identification Standards

    The European Medicines Agency (EMA) has announced it is putting together a task force to oversee the implementation of new standards for identifying drugs. The goal of the task force will be to develop a roadmap for EU-wide implementation of identification of medicinal products (IDMP) standards developed by the International Organization for Standardization (ISO). Background EMA recently issued an explanatory document titled Data submission of authorised m...
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    EMA Explains Centralized Product Database, Talks Future Changes

    The European Medicines Agency (EMA) released a new document intended to clarify data submission requirements for medicines authorized in the European Economic Area (EEA). In the document, the agency discusses the current status of its eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) and talks about planned changes through 2016. Pharmacovigilance in the EU Pharmacovigilance is the process of monitoring the use of drugs after they have entered the market. ...