Article | July 23, 2021

The Challenge With EMA's Changing Timelines For IDMP

Source: Phlexglobal

By Jim Nichols

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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 The result is that previously communicated milestones are no longer applicable – the publication of the EU Implementation Guides (EU IGs) will not take place in 2018 and industry will not be requested to start submitting the product data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?

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