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  Published Paper Details:

  Paper Title

A REVIEW ON: OVERVIEW OF CTD AND ECTD FOR REGISTRATION OF PHARMACEUTICALS

  Authors

  Ghanshyam Nawale

  Keywords

CTD, eCTD, ICH M4, ANDA, Regulatory requirement, Regulatory Affairs

  Abstract


The United States has the biggest pharmaceutical market in the world .Common Technical Documents (CTDs) are required in the European Union (EU), Japan, Canada, Switzerland, and Australia, and are recommended in the United States, according to the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). An electronic version known as the Electronic Common Technical Document (ECTD) was created concurrently with the CTD. Currently, the US, Europe, and Japan accept ECTD filings. The ECTD offers advantages over the CTD in terms of user-friendliness, archiving, and managing registration information throughout its lifecycle. For both clinical and nonclinical studies, the ECTD definition specifies the folder and content structures as well as the XML backbone and Study Tagging File. Considerations for ECTD documentation design include document granularity, templates, shell documents, and filing regional variations. An Integrated Summary of Safety and an Integrated Summary of Efficacy, for example, are mandated in the United States. The CTD offers a universally recognised structure that is internationally harmonised, removing the need to create distinct registration dossiers for distinct regulatory bodies. It is divided into five modules: Module 1 is peculiar to a particular region, whereas Modules 2, 3, 4, and 5 are meant to be shared by all regions. There is a regional component in Module 3. Pharmaceutical businesses can submit applications to regulatory agencies such as the FDA without changing the data by using the ECTD format. These days, the US, Japan, the EU, and Canada all make extensive use of it.

  IJCRT's Publication Details

  Unique Identification Number - IJCRT2401669

  Paper ID - 249194

  Page Number(s) - f682-f693

  Pubished in - Volume 12 | Issue 1 | January 2024

  DOI (Digital Object Identifier) -   

  Publisher Name - IJCRT | www.ijcrt.org | ISSN : 2320-2882

  E-ISSN Number - 2320-2882

  Cite this article

  Ghanshyam Nawale,   "A REVIEW ON: OVERVIEW OF CTD AND ECTD FOR REGISTRATION OF PHARMACEUTICALS", International Journal of Creative Research Thoughts (IJCRT), ISSN:2320-2882, Volume.12, Issue 1, pp.f682-f693, January 2024, Available at :http://www.ijcrt.org/papers/IJCRT2401669.pdf

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ISSN: 2320-2882
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Journal Starting Year (ESTD) : 2013
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ISSN and 7.97 Impact Factor Details


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ISSN: 2320-2882
Impact Factor: 7.97 and ISSN APPROVED
Journal Starting Year (ESTD) : 2013
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