22 August 2012

CSC: 2015 - the Mayans may have been off by three years – By Joel Finkle, Senior Strategist, Regulatory Services Delivery

Looking at pending regulatory changes, I have to wonder if a lot of regulatory affairs and operations are planning on retiring by 2014, because the following year there’s a lot of changes coming:

1) eCTD 4.0 (aka RPS) should be an approved ISO standard and there’s a good shot of it being accepted by all ICH regions

2) The IDMP ISO standard will be required for product registrations

3) FDA will require all NDAs to be in eCTD format

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