EMA Policy 0070 External Guidance Update

Even though the European Medicines Agency (EMA) has suspended publication of clinical data through Policy 0070 due to its Brexit business continuity plan, EMA posted a Policy 0070 external guidance update on November 11, 2018. Revision 4 is now in effect. Policy 0070 External Guidance Update – Major Changes Several major changes are noted in this … Continued

EMA Reasons for Rejection of CCI

New data from European Medicines Agency (EMA) confirms the tough position EMA is taking in regard to commercially confidential information (CCI). According to the European Medicines Agency’s “EMA Update on Clinical Data Publication” published on 29 January, 2018, 76% of CCI instances were rejected in 2017. Interestingly, the EMA has provided further insight on how … Continued

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