In:
International Journal of Drug Regulatory Affairs, Society of Pharmaceutical Tecnocrats, Vol. 1, No. 2 ( 2018-02-06), p. 7-10
Abstract:
The urgent requirement to rationalize and harmonize regulation was impelled by instance of rising cost of Healthcare, Research and Development and need to meet the public requirement to approach for the safe and efficacioustreatments to patient in need. ICH committee has given priority to harmonize the format of reporting data for quality,safety and Efficacy in the application dossier.ICH also provides different Guidelines under the topic Quality, Safety, Efficacy and Multidisciplinary to control thequality safety and efficacy of Pharmaceutical and Biotechnological products.For the dossier application part CTD provides harmonized format for product application. Earlier all the submissionssent to regulatory authorities in CTD, Paper format but it was a tedious job requiring lot of Time to review,documentation and paper work.Due to the advancement in Information technology, regulatory authorities from regulated countries throughout theglobe started to accept data in electronic format either in eCTD (Electronic common technical document)/ NeeS (NoneCTD electronic submission).The eCTD was developed subsequently by the ICH M2 Expert working group and allows for the electronicsubmission of the CTD from the applicant to regulator and provides harmonized technical solution for CTDelectronically. Many regulatory authorities completely eliminated the Paper submission and made eCTD mandatory.This is the centralized approach, saves time, cost, facilitate review process and greater transparency can be achievedvia central processing of submissions.Harmonization can also be seen in IPR stream by treaties and conventions. These international treaties andconventions contribute to the process of harmonization of patent laws.
Type of Medium:
Online Resource
ISSN:
2321-6794
,
2321-7162
DOI:
10.22270/ijdra.v1i2.4
Language:
Unknown
Publisher:
Society of Pharmaceutical Tecnocrats
Publication Date:
2018
detail.hit.zdb_id:
2738279-5
SSG:
15,3
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