Regulatory requirement for the approval of Generic Drug in Vietnam as per ASEAN Common Technical Dossier (ACTD)

  • Vruddhi Panchal K.B.institute of Pharmaceutical education and research
  • Utsav Patel
  • Vinit Movaliya
  • Khushboo Vaghela
  • Niranjan Kanki
  • Maitreyi Zaveri

Abstract

Drug approval process differs from one country to another country. The purpose of this study is to give a comparative overview on generic drug market regulation in ASEAN Countries Cambodia and Vietnam. The aim of study is to facilitate proper knowledge regarding main critical issues, differences as well as similarities of related drug regulation. There is a different requirement for registration of generic product in each regulatory system but also comprises of some similar outline that includes some common rules. These are variances and regulatory hurdles such as Number of batches for submission in dossier, stability conditions, registration of product, analysis, bioequivalence and clinical study requirement. ASEAN countries for generic drug product approval ACTD submitted to country specific authority. For solid oral dosage forms as per ASEAN guideline there are 4 parts have to be submitted. Part I contains Administrative requirements which is not a part of common technical document. Part II is Quality contains 3 sections that are a) Table of Content b) Quality overall Summary c) Body of data. Part III contains Non clinical. Part IV contains Clinical data. For the generic drug product Part III and Part IV is not required.

Keywords: ASEAN, Combodia, Vietnam, ACTD

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References

1. Requirements of New Pharma Registration Dossier inVietnam. [Internet]. kenfoxlaw; 2018 Nov 12 [cited 2022 Jan 15]. Available from:
https://kenfoxlaw.com/requirements-of-new-pharma-registration-dossier-in-vietnam
2. Guidelines for Implementation of the Law on Pharmacy. Decree [Internet]. vanbanphapluat; 2017 May 08 [cited 2022 Jan 16]. Available from:
https://vanbanphapluat.co/decree-54-2017-nd-cp-guidelines-for-implementation-of-the-law-on-pharmacy,cited on 08 MAY 2017
3. ASEAN Common Technical Dossier (ACTD) [Internet]. ASEAN; 2016 Dec [cited 2022 Jan 16]. Available from:
http://asean.org/storage/2017/03/68.-December-2016-ACTD.pdf
4. Department of Drugs and Food [Internet] Cambodia: ddfcambodia; 2022[cited 2022 Jan 16] Available from:
https:// www.ddfcambodia.com
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How to Cite
Panchal, V., U. Patel, V. Movaliya, K. Vaghela, N. Kanki, and M. Zaveri. “Regulatory Requirement for the Approval of Generic Drug in Vietnam As Per ASEAN Common Technical Dossier (ACTD)”. International Journal of Drug Regulatory Affairs, Vol. 10, no. 3, Sept. 2022, pp. 66-69, doi:10.22270/ijdra.v10i3.532.