REGULATORY REQUIREMENTS FOR DRUG PRODUCTS REGISTRATION IN SOUTH AFRICA

  • Senthil V.
  • L. Srianitha
  • R. Baviyapriyadharshini

Abstract

The South African Pharmaceutical market is one of the emerging markets in the world and it is important to study on how to register a drug in the promising pharmaceutical market in Africa. The MCC is the regulatory body which deals with the quality, safety and efficacy of the medicines in South African market which regulates by approving the medicines by very specific process which is unique to South African health system. They have a specific type of CTD for Regulatory submissions which is generally well known as ZA CTD. This article provides the insight on the Drug Registration process in South Africa, the details of data to be submitted to the agency and the pathways of registration an applicant can avail, categories a drug can be registered by MCC, Application fees to be paid to the agency on various types of applications are also dealt.

Keywords: ZA CTD, MCC, AMRP, CTC, MRF.

Downloads

Download data is not yet available.

References

1. Medicines Control Council, History of medicine regulation in South Africa [Internet]. Medicines Control Council; 1965 [cited 2015 Oct 05]. Available from: http://www.mccza.com/about/default.asp
2. Medicines Control Council [Internet]. MCC; 2003 [cited 2015 Oct 07]. Available from:
www.mccza.com
3. MCC composition and structure [Internet]. MCC; 1965 [cited 2015 Oct 04]. Available from:
http://www.mccza.com/MCC/default.asp
4. Medicines Regulatory Affairs [Internet]. MCC; 2015 [cited 2015 Oct 03]. Available from:
http://www.mccza.com/MRA/default.asp
5. Regulatory Requirements for the ZA CTD [Internet]. SAPRAA; 2010 Sep 15 [cited 2015 Oct 09]. Available from: www.sapraa.org.za.
6. Registration of medicines [Internet]. MCC; 2015 [cited 2015 Oct 02]. Available from:
http://www.mccza.com/dynamism/default_dynamic.asp?grpID=30&doc=dynamic_generated_page.asp&categID=177&groupID=30
7. Application form for registration of medicine [Internet]. MCC; 2015 [cited 2015 Oct 08].
Available from:
http://www.mccza.com/dynamism/default_dynamic.asp?grpID=30&doc=dynamic_generated_page.asp&categID=177&groupID=30 6.01_MRF1 application for registration of a medicine (Zip 39kb)
8. CTD Pagination document [Internet]. ICH; 2015 [cited 2015 Oct 11]. Available from:
http://www.ich.org/pdfICH/CTDPagination.pdf
9. Dossier requirements for registration of medicines in South Africa [Internet]. SAPRAA; 2010 [cited 2015 Oct 10]. Available from: www.sapraa.org.za
10. Review and approval process of drug product [Internet]. 2015 [cited 2015 Oct 12]. Available from: http://www.google.co.in/url?sa=t&rct=j&q=dossier%20review%20process%20in%20south% 20africa%20(mcc)&source=web&cd=9&ved=0CF8QFjAI&url=http%3A%2F%2Fwww.qdot pharma.com%2Fdocs%2FRequirements_for_MCC_submission.pdf&ei=neADUPVuhu2sB_ _A0ZEG&usg=AFQjCNFXFCAnxEB4cskhWbFNAOcfoNXlrw.
Statistics
762 Views | 2807 Downloads
How to Cite
V., S., L. Srianitha, and R. Baviyapriyadharshini. “REGULATORY REQUIREMENTS FOR DRUG PRODUCTS REGISTRATION IN SOUTH AFRICA”. International Journal of Drug Regulatory Affairs, Vol. 3, no. 4, Feb. 2018, pp. 1-8, doi:10.22270/ijdra.v3i4.171.

Most read articles by the same author(s)