The document discusses eCTD (electronic Common Technical Document), which is an electronic version of the Common Technical Document for submitting drug applications. It was established in 2002 by the M2 EWG and is maintained by the eCTD IWG. The USFDA and European Union now require electronic submission of drug applications using eCTD. Using eCTD provides benefits like better quality, reduced costs from eliminating paper and transportation, faster review times, and reduced environmental impact compared to paper submissions. eCTD submissions can include files in formats like PDF, XML, JPEG, PNG, SVG, and GIF.

1. eCTD
Presented by
Ch.Balakrishna
Department of Regulatory Affairs
Shri Vishnu College of Pharmacy

2. eCTD(electronic Common Technical Document)
• It is an electronic version of ctd
• Established in 2002
• Developed by M2 EWG
• Maintained by eCTD IWG
• eCTD is highly recommended by USFDA for NDAs, BLAs, DMFs and
INDs filling
• From year 2010 European union also make compulsory for electronic CTD
submission to all procedures.

3. WHY GO ELECTRONIC?
Quality
• Better quality
• Entire life cycle of product covered
• Easy and rapid call up of information
Costs
• Paper and transportation costs reduced
• Storage and archive requirements reduced
• Faster, more efficient review, quicker registration.

4. WHY GO ELECTRONIC?
Environmental responsibility
NCE is approx 2,40,000 pages
paper for this would be 672 kgs
equivalent to one average tree
an entire tree is required to submit
a single copy of the application form.

7. CONTENT FILES
• Portable document format (pdf)
• Extensible markup language (xml)
• Joint photographic experts group (jpeg)
• Portable network graphics(png)
• Scalable vector graphics(svg)
• Graphics interchange format (gif)

8. Comparing paper CTD and eCTD

9. Thank You