ACTD: BRIDGE BETWEEN REGULATORY REQUIREMENTS OF DEVELOPED AND DEVELOPING COUNTRIES

  • Achin Jain J.S.S. College of Pharmacy, S.S. Nagar, Bannimantap, Mysore, India.
  • M P Venkatesh J.S.S. College of Pharmacy, S.S. Nagar, Bannimantap, Mysore, India.
  • Pramod T.M. Kumar J.S.S. College of Pharmacy, S.S. Nagar, Bannimantap, Mysore, India

Abstract

Regulatory Dossier contains data which when submitted to the regulatory authority, provides for the review and
ultimate approval of a drug product. Once approved, an applicant may manufacture and market the drug to provide a
safe, effective and low cost which benefits the society. Filing requirements in developed countries differ from
developing countries which makes the approval process tedious and time consuming for the later. To make this
process smooth, ASEAN CTD (ACTD) was developed by Association of South East Asian Nations (ASEAN)
nations. As format of ACTD resembles the format of Common Technical Document (CTD) with some differences,
hence it can be used as a step. Also if both guidelines can be harmonized then differences and variation between both
the guidelines can be minimized. This article focuses on the similarities and differences in between CTD & ACTD
and highlights how ACTD can be a initiating step for developing countries to meet pharmaceutical regulations of
developed countries.

Keywords: ACTD, ASEAN, CTD, eCTD, ICH.

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Author Biographies

Achin Jain, J.S.S. College of Pharmacy, S.S. Nagar, Bannimantap, Mysore, India.

J.S.S. College of Pharmacy, S.S. Nagar, Bannimantap, Mysore, India.

M P Venkatesh, J.S.S. College of Pharmacy, S.S. Nagar, Bannimantap, Mysore, India.

J.S.S. College of Pharmacy, S.S. Nagar, Bannimantap, Mysore, India.

Pramod T.M. Kumar, J.S.S. College of Pharmacy, S.S. Nagar, Bannimantap, Mysore, India

J.S.S. College of Pharmacy, S.S. Nagar, Bannimantap, Mysore, India

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How to Cite
Jain, A., M. Venkatesh, and P. Kumar. “ACTD: BRIDGE BETWEEN REGULATORY REQUIREMENTS OF DEVELOPED AND DEVELOPING COUNTRIES”. International Journal of Drug Regulatory Affairs, Vol. 1, no. 4, Dec. 2013, pp. 1-11, doi:https://doi.org/10.22270/ijdra.v1i4.6.