The Challenge with EMA’s Changing Timelines for IDMP

By 18. July 2017Blog

A combination of factors has resulted in the shifting timeline of EMA’s implementation of the IDMP data collection. One factor is the pending relocation of EMA due to Brexit. Additional factors include the experience gained from implementation of RMS and OMS projects and the delivery method of the P&SMS project to engage the stakeholders. The result is that previously communicated milestones are no longer applicable – the publication of the EU Implementation Guides (EU IGs) will not  take place in 2018 and industry will not be requested to start submitting the product data in a new format in 2019.

So how is this impacting industry?

The IDMP challenge: IDMP initiatives have been started in many conpanies and significant effort and investment has been made. What will these companies do with the substantial knowledge, information and analyses they have already developed? Throw it all away? Hold onto it and hope it’s still relevant in 2 years? Is this a risk worth taking?

The xEVMPD challenge & opportunity: The fact is that Article 57 (and xEVMPD) is still in effect. In here the challenge becomes the opportunity!  An observation can be made that the efforts and research conducted in the name of IDMP can be leveraged to improve the information collection and management processes related to xEVMPD as a stepping stone toward eventual IDMP implementation. Perhaps moving away from manual data entry processes via EVWeb and toward more automated solutions is the right next step for many companies. A company addressing the challenge of managing multiple data sources that converge around xEVMPD, along with the processes related to verifying information received from EVWeb (such as invoices) will be energy well spent.

 

The SPOR way or not?

Organizations (OMS) and Referential (RMS) data will be available to the industry from Q4 2017 onwards. While IDMP in Europe has been delayed, the Organization and Referential database will be made available for industry toward the end of 2017. Companies will need to develop a strategy on how to consume and use the data. This strategy needs to include aspects such as what type of data alignment will need to happen – directly using RMS/OMS terms or mapping currently used terms to RMS/OMS. Finally, these companies will want to determine how the alignment process should be implemented – manual downloads or automated integration via an API integration. Data remediation may be the best focus for those looking to align internal systems with these external information stores.

 

The RIM opportunity: Many companies have not addressed their regulatory information management (RIM) needs because IDMP was a driver to refresh these systems. With IDMP delays and internal IDMP projects being frozen – yet still needing to comply with Article 57 – the opportunity presents itself to evaluate and address the organizational and functional needs related to RIM and to re-stabilize and refresh these platforms well in advance of IDMP.

Ultimately, most companies are using outdated technology or even more basic approaches such as spreadsheets to track regulatory information. By solving the RIM problem now will help in addressing usability issues, data duplication/redundancy and compliance risks well in advance of any looming regulatory deadline.

 

Author Jim Nichols

Jim is the vice president for Life Sciences in North America. He has nearly 20 years of experience with compliant software solutions for regulated processes. Jim has worked in senior management positions at Liquent, Thomson Reuters, ePharmaSolutions and DitaExchange. Jim has a Bachelor of Science degree in Mathematics from the Pennsylvania State University.

More posts by Jim Nichols

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