Act now – or risk running out of time for IDMP
pharmafile | February 23, 2015 | Feature | Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing | EMA, Eversheds, ISO, icsr, idmp, regulatory
Many people in pharma would argue that the world of regulatory compliance in the life sciences industry is already complicated enough.
Regulation in the sector is notoriously strict, and rightly so. Each country has its own rules and red tape for companies, so it is legitimate to question whether there’s any room or benefit to be had from adding another layer of regulation – this time for data and nomenclature – across Europe.
But that’s what the EMA is planning, with the implementation of the Identification of Medicinal Products (IDMP) standards.
These are a batch of five linked standards for information management, set and co-ordinated by the International Organization for Standardization (ISO). How much of a headache this new legislation creates will depend on how well companies prepare, and how industry regulators support firms to avoid the potential pitfalls.
The five standards cover medicinal products, pharmaceutical product identifiers, substance identifiers and specified substance identifiers, control vocabularies and units of measurement. Each standard is geared towards standardising information about how drugs should be used, consumed and packaged.
The purpose of the standards, according to the ISO, is “to specify definitions of terms for all data elements required to uniquely and with certainty identify medical products for human use”.
In practical terms, this means regulatory affairs departments and others responsible for filing applications with the EMA will need to comply with these new rules and adjust their process accordingly before the standards come into force in July 2016.
IDMP will mean pharmaceutical manufacturers have a universal system for identifying medicinal products. The aim is to simplify the exchange of data between manufacturers of medicines across Europe, says Carl Fennessy, an associate in company commercial law at corporate law firm Eversheds.
“The benefits are primarily aimed at patients – to make sure that any adverse events are picked up. The next set of benefits are supposed to be for regulators and marketing authorisation holders, so that they are very clear on the information that needs to be submitted and the standards of the information.
“In the longer-term it’s hoped that more regulators will begin to move towards these standards and allow more companies to use the data globally. That will hopefully drive down costs – that’s one of the reasons behind it. ”
IDMP will also be used in monitoring individual case safety reports (ICSRs).
Currently every country has different identifiers for ICSRs, which makes tracking patient safety alerts difficult. Under IDMP, the vision is that every product would be identified in the same way.
This will theoretically make it easier to classify similar items, track reports of suspected adverse reactions to medicines, and find trends in safety reports. IDMP will also be used to manage issues related to potential contamination and product recalls.
There could be other benefits for pharma too. Andrew Marr, a member of the ISO technical committee that is developing the standards, says: “It’s not just about pharmacovigilance and getting information to regulators. Implementing IDMP has the opportunity at least to allow companies to use these standards internally to overcome silos in their own systems.
“So companies that are implementing things now are saying ‘we’re going to use the standards internally to help our systems talk to each other’ – quite apart from the external requirements. Then, when the guidance comes out they’re going to be in a much better position to respond.”
There’s a limit to how early it’s realistic to start preparing, though. Neither the ISO nor the EMA are likely to have produced any roadmaps or implementation guidelines before summer 2015. But because of the amount of analysis and preparation that will be required, companies will need to start planning well before then to be ready to implement the IDMP in a strategic way.
“There isn’t a huge amount of data out there from the EMA at the moment”, Fennessy says. “They are still working on a roadmap for implementing the standards, and we still only have a rough date of July 2016 for when the standards will be implemented.
“But most companies should have already been looking at the data that they have submitted and updating that with the latest, up to date information – the process should have already begun.”
Indeed the EMA’s intention was to start upgrading its own data entry tools by the end of December 2014 – and it expected the industry to start resubmitting data they had previously submitted in line with the newer standards, to make the transition to the ISO standards easier.
Unlike its predecessor, the eXtended EudraVigilance Medicinal Product Dictionary (XEVMDP), which was only an EU requirement, IDMP is mandatory. But it’s not clear yet what the resource implications will be.
Unofficial estimates put the cost of the XEVMPD standards to the industry at as much as €100 million in systems and resources – and the predictions are that IDMP will most likely be a far larger task.
“The scope of IDMP is much wider than XEVMPD,” Marr says. “It involves other parts of the business, manufacturing, regulatory, pharmacovigilance and potentially commercial, and so the breadth of data is much wider than what we already know we’ve got problems with in XEVMPD.”
It’s difficult to know what position companies that do not meet the July 2016 deadline will be in, or if there will be penalties enforced. The IDMP mandate is part of an EU regulation issued by the European Commission, so it’s possible that the EC could enforce regulations that govern “financial penalties for infringement of certain obligations in connection with marketing authorisations”.
So far, experts are divided on whether this will actually happen. Simon Crossley, head of life sciences at Eversheds, says: “I think typically there’ll be a period where the agencies will take a fairly soft view about the submission of their data, but I suspect in due course the practice will simply be rejection if you don’t submit in the correct format.”
Marr disagrees: “Failing to comply with pharmacovigilance regulations throws you into the world of penalties regulations – a penalty of 0.5% of your daily or annual turnover in the EU. However, there’s no case example of the EMA actually doing that and under XEVMPD nobody’s chasing around for the data.”
Although there will be work to do for most manufacturers, industry experts all agree that – if the ISO and EMA meet their milestones for producing guidelines – then there will be enough time.
A key date will be in mid-March 2015 when the ISO technical committee meets to approve draft guidelines, which could be available for consultation by the end of the year. But the implementation is a case of when, not if.
The EMA has set the industry the challenge of mandatory compliance by July 2016. The implications are yet to be fully understood, but it is worthwhile getting prepared, Crossley says.
“It will require a change in practice, and whenever something new comes in there’s always a period of nervousness as to whether we’re doing the right thing.
But once you have a system and you know what you’re doing, you can implement that in your business – and away you go.”
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