ICH’s Value to Regulatory

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The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is unique in bringing together the regulatory authorities and pharmaceutical industry to discuss scientific and technical aspects of drug registration. Since its inception in 1990, ICH has gradually evolved, to respond to the increasingly global face of drug development. ICH’s mission is to achieve greater harmonisation worldwide to ensure that safe, effective, and high-quality medicines are developed and registered in the most resource-efficient manner. Read More

The Challenge with EMA’s Changing Timelines for IDMP

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 The result is that previously communicated milestones are no longer applicable – the publication of the EU Implementation Guides (EU IGs) will not  take place in 2018 and industry will not be requested to start submitting the product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

SPOR Blog July 2017

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EMA will invite industry stakeholders to begin registering their super users and start using the RMS and OMS from October 2017.

Until the registration begins (October) industry stakeholders can view and search public data as guest users. In case of RMS, guest users can view public lists and for OMS, all content can be viewed. The OMS dictionary (list of organizations with associated physical locations) currently only includes NCA organization data and the dictionary will gradually be expanded with new data. Read More