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Regulatory News | 24 February 2015 | By Michael Mezher
The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) announced it has completed a step in the development of the next major version of the electronic Common Technical Document (eCTD).
ICH’s M8 expert working group (EWG) has completed a draft of the implementation guide for ICH eCTD v4.0, the first major version change since v3.0 was adopted in 2003.
ICH was formed following discussions that took place between Europe, Japan, and the US in the 1980s on harmonizing regulatory requirements. Since its formation, ICH has made strides toward harmonizing standards through projects such as MedDRA, a specialized medical terminology dictionary, and the Common Technical Document (CTD), which allows companies to submit documentation to a number of regulatory authorities without reformatting the information.
The eCTD is an XML-based electronic version of the CTD, which has become the preferred submission format for both the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA).
The move from the current version, eCTD v3.2.2, to v4.0 is being driven by several needs and improvements identified over the past several years.
To facilitate more streamlined submissions, eCTD v4.0 will allow for all regional and harmonized content to be placed in one consolidated exchange message. Documents can also be reused in subsequent submissions, as each eCTD will be assigned a unique identification code. Additionally, eCTD will allow for greater editing functionality, which will allow for changes without resubmitting the document.
For a full description of the changes discussed in the eCTD v4.0 implementation guide please follow the download instructions on the ICH eCTD v4.0 Step 2 website.
ICH uses a five-step procedure to develop its guidelines. The steps represent a gradual progression from identifying a work area to building consensus and implementing guidelines.
Following the release of the draft implementation guide, ICH will begin the consultation period (Step 3). When the consultation and discussion period is complete a final guideline is expected to be adopted (Step 4) in November 2015. Once adopted, the national regulatory authorities in ICH countries will implement the guideline (Step 5).
ICH is encouraging stakeholders to submit comments on the draft implementation guide by 22 May 2015.
ICH Press Release
Tags: ICH, International Conference on Harmonization, eCTD, electronic submissions