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


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.


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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.

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