HARMONIZATION & ADVANCEMENT IN PHARMACEUTICAL INDUSTRY

  • Jitendra Kumar Badjatya Department of Pharmacy, JJT University, Chudela, Jhunjhunu, Rajasthan. India
  • Ramesh Bodla Department of Pharmaceutical Chemistry, DIPSAR New Delhi, India

Abstract

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.

Keywords: ICH, CTD, eCTD, NeeS, Multidisciplinary, WTO, IND, NDA, ANDA, BLA, DCP, CP, MRP, ACTD, PLT

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Author Biographies

Jitendra Kumar Badjatya, Department of Pharmacy, JJT University, Chudela, Jhunjhunu, Rajasthan. India

Department of Pharmacy, JJT University, Chudela, Jhunjhunu, Rajasthan. India

Ramesh Bodla, Department of Pharmaceutical Chemistry, DIPSAR New Delhi, India

Department of Pharmaceutical Chemistry, DIPSAR New Delhi, India

References

[1] M4: The Common Technical Document
[Internet].[cited 2012 Oct.] Available from
www.ich.org/products/ctd.html
[2] The eCTD (Electronic Common Technical Document)
[Internet].[cited 2012 Sept] Available from
http://esubmission.emea.europa.eu /doc/eCTD%20
Guidance%20Document%201.0%20final%20for%20publ
ication.pdf2
[3] TIGes Harmonised eCTD Guidance [Internet].[cited
2012 Nov.] Available from http://esubmission.ema
.europa.eu/ tiges/docs/eCTD%20Guidance%20Document
% 202 % 200_ 2011 _ TIGes %20 adoped%20for%20
publication.pdf
[4] Regulatory Information [Internet]. [Cited 2012 Oct]
Available from http://www.fda.gov/Regulatory
Information/Guidances /ucm129901 .html
[5] The Patent Cooperation Treaty (PCT) [Internet].[cited
2012 Dec] Available from http://www.commercial
diplomacy. org /ma_projects/kinoshita.htm
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How to Cite
Badjatya, J. K., and R. Bodla. “HARMONIZATION & ADVANCEMENT IN PHARMACEUTICAL INDUSTRY”. International Journal of Drug Regulatory Affairs, Vol. 1, no. 2, Feb. 2018, pp. 7-10, doi:10.22270/ijdra.v1i2.4.