IDMP (Identification of Medicinal Products) Are you ready for the implementation?
In June 2012, with the aim of improving EU-wide pharmacovigilance, the EU Parliament approved Regulation No. 520/2012 – also known as IDMP (Identification of Medicinal Products). It calls on the EMA to provide a central register of medicinal products for human use which are authorized and in development in the EU. Strict deadlines are stipulated for the transfer of product information in the case of new authorizations and authorization changes, as well as for investigational medicinal products. The EU Commission is going a significant step further in its embodiment of the law than was achieved by previous regulations. The Commission has now provided clear reference standards for ISO / FDIS 11615, 11616, 11238, 11239 and 11240 within the wording of the law, which should provide for and ensure the homogeneous terminology and structure of all pharmacovigilance and product information.
The provision was originally intended to be binding on all affected authorization holders (Market Authorization Holders, MAHs) from 1 July 2016. However, since then there have repeatedly been time delays and an iterative, step by step introduction was planned. Reasons for repeated postponement are currently mainly the challenges for the planned EMA relocation, which is confronted by the European Medicines Agency.
On our partner website idmp1.com you can download the official ISO IDMP brochure free of charge.
Drug manufacturers are faced with many unanswered questions about the practical implementation of IDMP and have to cope with the constant pressure of deadlines running out and potential penalties for non-compliance.
The EMA has not published any requirements and guidelines for the implementation of IDMP (as of: June 2017). A release of the EU Implementation Guides is currently not planned before 2019, so the binding introduction of the first iteration would enter into force for the industry at the earliest in 2020. The scope of the data required for the first iteration has been approved. The EMA has set up an “EU ISO IDMP Task Force”, which is intended to support the industry with the development of a roadmap for EU-wide implementation and has submitted proposals for this implementation.
In addition to time constraints, the industry is faced with organizational, technical and coordination challenges: IDMP-relevant data are distributed cross-functionally in different business areas (especially for substances and packaging information), as well as various IT systems or third-party suppliers. Active sponsorship by senior management and an effective change and project management for the control and involvement of all stakeholders is therefore essential. The effort required from both a personnel and a technical-IT aspect for the identification, gathering and consolidation of all IDMP-relevant information is enormous.
The complete ISO IDMP standard will require around 10 times the amount of data that was needed for XEVMPD.
IDMP is more than compliance. Anyone who implements the new regulations with a long-term and sustainable approach will raise their Master Data Management (MDM) skills to a higher level. The intelligent integration of product information, IT systems and processes ensures a new, fully-integrated approach to product data with homogeneous terminology and integrated structures.
Against this complex background, we recommend a two-step implementation strategy: In order to establish both short and medium term IDMP compliance and to avoid any penalties, we advise the adoption of a tactical approach in stage one, whereby risk-based approaches are also employed. For long-term and sustainable implementation in the affected business units and processes, a strategically-aligned roadmap is of key importance for stage two. This will enable the optimal use of synergy effects and opportunities for the management of product data.
In partnership with IDMP1 GmbH and its managing director Ursula Tschorn, ARCONDIS is available to answer any questions relating to the implementation of ISO IDMP by means of a dedicated and competent team of advisors. Ursula Tschorn is a member of the European Union (EU) International Organization for Standardization (ISO) Identification of Medicinal Products (IDMP) task force, which was established by the EMA, and that means she has her finger on the pulse of IDMP development.
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