Abstract

DRUG REGISTRATION IN SOUTH AFRICA

*Shaik Azeem, S. B. Puranik, Yaseen Irfan, S. M. Maaz and Syed Kashif

ABSTRACT

The purpose of this study is to assess the steps in the drug registration process in South Africa along with new updates in its policies along with change in submission codes. The details of data to be submitted to the agency and the pathways of registration an applicant can gain; categories a drug can be registered by MCC, Application fees to be paid to the agency on various types of applications are also dealt. South African Health Products Authority (SAHPRA) is the regulatory authority of South Africa responsible for the regulation of health products intended for human and animal use. Its core business includes tasked with regulating monitoring, evaluating, investigating, inspecting and registering all health products.[1] This includes clinical trials, complementary medicines, medical devices and in vitro diagnostics. The guideline for CTD submission provides recommendations for applicants preparing a Common Technical Document for the Registration of Medicines (CTD) for submission to the South African Health Products Regulatory Authority (SAHPRA). The document describes how to organize applications based on the International Council for Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) guidelines on the CTD. The registration of medicine in South Africa is governed by the provisions and requirements of the Medicines and Related Substances Control Act No. 101 of 1965[2], (hereafter 'the Act) and the Regulations and Guidelines published in terms thereof. The submission codes have been updated with respect to the new rules and different groups responsible for submissions and registration of medicines and a new code for variation also has been adopted.

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