PREPARATION & COMPILATION OF ACTD DOSSIER (PART II QUALITY)

  • Rajkumar M. Gupta

Abstract

ACTD is a critical document for drug substance and produces registration in ASEAN region. The document is essentially divided into 4 parts. Each part provides information under specific head. Out of all the parts, the part II is most important. This part not only evaluates technical suitability of the product but also determines the suitability of active drug and Excipients.


The major stress in this part is on formulation, manufacturing, stability and process validation. The information required under this part is suitably detailed in this article.

Keywords: ASEAN, ACTD, Excipients, Compendial.

Downloads

Download data is not yet available.

References

1. Horns A. General requirements for a new marketing authorization application with focus on ASEAN [Internet]. University of Bonn, DRA Dept.; 2009 April 25 [cited 2015 March 21]. Available from:
http://www.harald-g-schweim.de/Hoerner-2009.pdf
2. Food and Administration, Philippines [Internet]. ACTD/ATR Drug Registration Requirements; 2005
[cited 2015 March 30]. Available from: http://www.fda.gov.ph/industry-corner/downloadables/217-requirements-for-drug-registration/95567-actd-atr-requirements
3. Javroongrit Y. The ICH-Global Cooperation Group Meeting, Regional Update – ASEAN PPWG [Internet]. [Japan] 2012 June [cited 2015 March 15]. Available from:
http://www.ich.org/fileadmin/Public_Web_Site/Meetings/C-GCG_Reports/2012/June_2012_ASEAN.pdf
4. National Pharmaceutical Control Bureau Ministry of Health Malaysia [Internet]. Malaysia: Drug Registration Guidance document; 2011 April [cited 2015 March 29]. Available from:
http://apps.who.int/medicinedocs/documents/s18589en/s18589en.pdf
5. Health Sciences Authority [Internet]. Singapore: ACTD - Guidelines on Drug Registration; 2011 [cited 2015 March 27]. Available from:
http://www.hsa.gov.sg/content/dam/HSA/HPRG/Western_Medicine/Overview_Framework_Policies/Guidelines_on_Drug_Registration/ACTD_OrganizationofDossier.pdf
Statistics
212 Views | 1199 Downloads
How to Cite
Gupta, R. M. “PREPARATION & COMPILATION OF ACTD DOSSIER (PART II QUALITY)”. International Journal of Drug Regulatory Affairs, Vol. 3, no. 2, Feb. 2018, pp. 17-21, doi:10.22270/ijdra.v3i2.164.