@article{Badjatya_Bodla_2018, title={HARMONIZATION & ADVANCEMENT IN PHARMACEUTICAL INDUSTRY}, volume={1}, url={https://ijdra.com/index.php/journal/article/view/4}, DOI={10.22270/ijdra.v1i2.4}, abstractNote={<p>The urgent requirement to rationalize and harmonize regulation was impelled by instance of rising cost of Health<br>care, Research and Development and need to meet the public requirement to approach for the safe and efficacious<br>treatments to patient in need. ICH committee has given priority to harmonize the format of reporting data for quality,<br>safety and Efficacy in the application dossier.<br>ICH also provides different Guidelines under the topic Quality, Safety, Efficacy and Multidisciplinary to control the<br>quality safety and efficacy of Pharmaceutical and Biotechnological products.<br>For the dossier application part CTD provides harmonized format for product application. Earlier all the submissions<br>sent to regulatory authorities in CTD, Paper format but it was a tedious job requiring lot of Time to review<br>,documentation and paper work.<br>Due to the advancement in Information technology, regulatory authorities from regulated countries throughout the<br>globe started to accept data in electronic format either in eCTD (Electronic common technical document)/ NeeS (Non<br>eCTD electronic submission).<br>The eCTD was developed subsequently by the ICH M2 Expert working group and allows for the electronic<br>submission of the CTD from the applicant to regulator and provides harmonized technical solution for CTD<br>electronically. Many regulatory authorities completely eliminated the Paper submission and made eCTD mandatory.<br>This is the centralized approach, saves time, cost, facilitate review process and greater transparency can be achieved<br>via central processing of submissions.<br>Harmonization can also be seen in IPR stream by treaties and conventions. These international treaties and<br>conventions contribute to the process of harmonization of patent laws.<br><br></p&gt;}, number={2}, journal={International Journal of Drug Regulatory Affairs}, author={Badjatya, Jitendra Kumar and Bodla, Ramesh}, year={2018}, month={Feb.}, pages={7-10} }