SAHPRA publishes the long-awaited SA GCP 3rd edition

The health regulator publishes latest guideline as it looks to encourage more efficient approaches to clinical trials.

Referred to as SA GCP 2020, the latest edition of the SA Good Clinical Practice supersedes the Guidelines published in 2006. According to the preamble of the Guidelines, written by the health minister Dr Zweli Mkhize, the revision was done in collaboration with SAHPRA, led by Dr Boitumelo Semete-Makokotlela, the Department of Health (DoH) and the National Health Research Ethics Council. It also states that the Guidelines have been carefully revised to align with the DoH Ethics in Health Research Guidelines 2nd edition 2015 (DoH 2015). The Guidelines are also said to align with the International Council of Harmonisation (ICH) Harmonised Tripartite Guideline: Guideline for Good Clinical Practice E6 (R2) 2016, which defines the golden standard globally.

According to Mkhize, they “encourage improved and more efficient approaches to clinical trial design, conduct, oversight, recording and reporting, to ensure continued adherence to the highest ethical and scientific standards to promote protection of participants as well as validity of trial results.” Compliance to SA GCP 2020 is compulsory as these are established in terms of sections 90(s) and 72(6)(c) of the National Health Act, Act No. 61 of 2003 as well as Regulation 30 of the Medicines and Related Substances Act, Act No. 101 of 1965. In addition to providing guidance to how the scientific aspects of trials are to be approached, clinical trial guidelines are key to ensuring the rights, safety and well-being of participants taking part in clinical trials are safeguarded.