Starting from mid-2018, all pharmaceutical companies having medicinal products registered on the EU market will have to have submitted IDMP-compliant data for these products. IDMP stands for identification of medicinal products and refers to five ISO standards defining terms and structures to uniquely identify medicines. While big pharmaceutical companies usually have projects started to ensure IDMP-compliant submission and maintenance of the data, SME companies are mostly still in a phase of orientation.
SME companies are currently analysing the requirements to create their own company approach towards compliance and to estimate the cost of it. Most SME companies plan to start projects in 2017 when detailed guidelines for IDMP requirements are to be published by the EMA.
SME companies usually face the following challenges on their way towards IDMP compliance:
- Usually no dedicated function for master data management/ regulatory data management
- Limited resources available to train employees on IDMP requirements and to keep up to date with changing information
- Limited financial resources for additional software
- Limited resources (FTE/external costs) for data collection/ submission/ maintenance
Lack of Benefit
- No internal business case for IDMP compliance: IDMP compliance is cost only
Limited Official Information
- Final timelines not published by EMA yet
- Final requirements not published by EMA yet
- EMA database not published yet
However, IDMP compliance is not a mystical quest that cannot be solved by common sense. This post will describe 7 different channels of how to stay informed about IDMP requirements and implementation plans of the EMA and will compare their efficiency for SME.
Information Channels for SME Companies
One major challenge for SME companies is to stay informed about authority plans and requirements for IDMP compliance. While requirements are being defined and implementation plans are being changed by the EMA, direct information from EMA has been very scarce over the last years.
The following sources to stay updated about IDMP should be considered:
1. EMA website
EMA publishes official information regarding IDMP implementation on its website. The website also includes a webinar given by the EMA in August 2016 as well as meeting notes from the IDMP task force.
2. ISO standards and implementation guides
The ISO standards and ISO implementation guides can be bought online. They are currently under revision and new versions are expected in 2017 (for standard 11615 and 11616 in the second quarter, for standard 11238 in the fourth quarter, for implementation guide for ISO 11238 in the first quarter, for implementation guide for ISO 11615 in the second quarter of 2017).
The ISO standards ISO implementation guides will serve as a basis for the EU implementation guides. The EU implementation guides will define the actual requirements for the EEA and are currently created by the IDMP task force.
As long as EU implementation guides are not available, ISO standards and implementation guides give the most detailed information on which requirements for IDMP compliance can be expected. Special attention should be paid to the standards of the medicinal product and substances as well as the technical implementation guides.
3. Direct via IDMP task force
The EU IDMP task force consists of representatives of EU institutions like the EMA and NCAs, representatives of the pharmaceuticals industries and other interest groups like vendors. The task force is developing and implementing IDMP requirements in the EU. For big pharmaceutical companies and vendors in the area of RA data organisation, participating in the IDMP task force also serves as a direct channel to the implementation of IDMP. However, even within the task force, a lag of information delivery from EMA to industry/vendor representatives prevailed.
Participating in the IDMP task force does not only require sufficient time but also specific knowledge in the field. Therefore, it seems natural that this is not the information channel of choice for SME companies. However, information from recent task force activities can be found on the EMA websites in the task force meeting minutes and are also exchanged via the IRISS forum as described in point 2.1.6.
4. Conferences, external training
Since 2014, the number of conferences and professional training focusing on IDMP has steadily risen. Speakers from industry, vendors, and authorities can give valuable insights to their IDMP implementation projects. However, again mostly big pharma companies are attending, as conferences and training are costly and SMEs lack functions dedicated to the subject. Bigger companies already involved in internal IDMP projects are often updated by vendors and consultancies part of the project team.
SME companies not starting IDMP projects yet might consider using an in-house training held by experienced consultancies to inform all involved functions about IDMP instead.
5. Informal networking
As official information from the EMA has been scarce, direct information from task force members has proven a helpful source of information. Informal exchange based on personal contacts also is highly helpful when implementing IDMP within the own organisation. Related functions in other companies usually face similar problems and solutions and experiences can be exchanged. Again, big pharma companies with functions dedicated to the subject have been in advantage here while RA departments often feel responsible for IDMP in SME companies. Nevertheless, exchanging experiences regarding IDMP implementation with related functions in other companies can be a highly useful, cost- and time-efficient source of information for SME companies as well.
6. IRISS forum
The IRISS forum refers to itself as “A Non-Profit Dedicated to Implementation of Regulatory Submission Standards Around the World”. Related subjects are discussed within topic groups and webinars, members come mostly from industry and vendor organisations. The IDMP topic group meets in a monthly t-con. The agenda usually focuses on recent activities of the EU IDMP task force and of the ISO technical committee currently updating the ISO standards. Speakers usually are members of both organisations. IRISS members can add questions, issues regarding xEVMPD activities are discussed as well. Records, as well as notes of the meetings, are published afterward. The forum also conducts surveys and collects feedback for the EU IDMP task force from its members.
As membership is comparatively inexpensive, SME companies should consider it as a cost- and time-efficient source of up to date information.
7. EMA efforts to cascade information
In its August webinar, EMA described its approach to set up a change network to cascade information regarding IDMP more efficiently. EMA will appoint industry change liaisons. Industry change liaisons will come from the IDMP task force. They are meant to cascade information and best practices directly and interactively to industry as well as to give feedback to EMA change network if additional communication is needed. They are meant to work together with key contact points at industry organisations to identify suitable communication channels like conferences or forums where they can present and communicate about IDMP. The industry is asked to get in touch with industry change liaisons if opportunities are identified that they can communicate with a wider range of industry stakeholders.
EMA promised to publish contact information of industry change liaisons soon. It needs to be evaluated how effectively they will improve communication. SME companies might want to contact their industry organizations regarding any related activities planned.
According to EMA, the SME office is also responsible for cascading information to SME and registered SME companies can submit questions there as well.
In August 2016, the IRISS forum conducted a survey of its members about their IDMP compliance activities. The results are publicly available: https://www.iriss-forum.org/news/iriss-publishes-the-results-readiness-surveys-for-idmp
One of the questions asked was how companies stay informed about IDMP compliance. Most of the 29 industry members answering the survey reported that they received information about IDMP implementation either directly from the task force, via the IRISS forum or from vendors and consultancies. When asked about their preferred source of information, however, almost all companies reported that they wish to receive information directly from the authorities.
While it is unclear whether more information directly from the EMA will be available in the future, companies currently are still asked to use various other information channels.
For SME companies the following approach can be helpful.
- Start with an in-house workshop to bring all involved functions to the recent level of IDMP information. The workshop should also answer all open questions regarding the contents of the ISO standards and ISO implementation guides. Xendo offers workshops as part of its IDMP consultation services. Please contact us for more information.
- Stay informed about new information using the following channels:
The EMA website should be checked regularly for any updates
Appoint a function to follow the discussions on the IRISS forum
Network with peers to get informed about experiences from organisations similar to your own.