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
To find more information please use the below mentioned weblink
http://www.csc.com/health_services/blog/74101/88217-2015_the_mayans_may_have_been_off_by_three_years
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
To find more information please use the below mentioned weblink
http://www.csc.com/health_services/blog/74101/88217-2015_the_mayans_may_have_been_off_by_three_years
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