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A policy document on the programme indicates its objectives as including developing a common technical document for registration of medicines, common information management system (IMS) for the registration, a quality management system in each national medicines regulatory authority ; and building regional and national capacity to implement the programme.
Meanwhile EMEA has also released answers supplied to the ICH within debates on important regulatory harmonisation questions, for instance on common technical documents for the registration of pharmaceuticals for human use--see http://www.
Mr Nasser said key issues to be discussed would include pharmaco-vigilance and economics, counterfeits, quality innovation, good manufacturing practices, including a common technical document, and electronic submission therapies.
Certainly ICH is taking on some of that already, in the form of the common technical document," Peterson said.
As a result of this decision, Osiris intendeds to promptly submit the full Common Technical Document to Swissmedic in the electronic or eCTD format to facilitate review.
PHILADELPHIA, June 24 /PRNewswire/ -- Health Canada, as well as all regulatory authorities who receive electronic Common Technical Document (eCTD) submissions for human therapeutics, is reporting problems with lack of compliance with the electronic format.
The ICH defined a process by which this standardization would occur, and in November 2000 the ICH Steering Committee met in San Diego, CA to ratify the guidelines describing the Common Technical Document for the Registration of Pharmaceuticals for Human Use (CTD).
The requirements for Electronic Common Technical Document (eCTD)-compliant submissions are unique and must be applied to documents that are constantly evolving.