Harmonization & Advancement in Pharmaceutical Industry

Badjatya Jitendra Kumar ； Bodla Ramesh

《International Journal of Drug Regulatory Affairs》 1卷2期 (2013/08) Pp. 7-10

並列摘要

The urgent requirement to rationalize and harmonize regulation was impelled by instance of rising cost of Health care, Research and Development and need to meet the public requirement to approach for the safe and efficacious treatments 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 the quality safety and efficacy of Pharmaceutical and Biotechnological products. For the dossier application part CTD provides harmonized format for product application. Earlier all the submissions sent 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 the globe started to accept data in electronic format either in eCTD (Electronic common technical document)/ NeeS (Non eCTD electronic submission). The eCTD was developed subsequently by the ICH M2 Expert working group and allows for the electronic submission of the CTD from the applicant to regulator and provides harmonized technical solution for CTD electronically. 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 achieved via central processing of submissions. Harmonization can also be seen in IPR stream by treaties and conventions. These international treaties and conventions contribute to the process of harmonization of patent laws.

並列關鍵字

ICH ； CTD ； eCTD ； NeeS ； Multidisciplinary ； WTO ； IND ； NDA ； ANDA ； BLA ； DCP ； CP ； MRP ； ACTD ； PLT