The South African Regulatory System: Past, Present, and Future
The drive for improved regulatory systems and the establishment of a more effective regulatory framework in South Africa has been evident for the past two decades but despite political intentions and legislative revisions success has been limited to date. Efforts to address the increasing volume of...
Main Authors: | , , , |
---|---|
Format: | Article |
Language: | English |
Published: |
Frontiers Media S.A.
2018-12-01
|
Series: | Frontiers in Pharmacology |
Subjects: | |
Online Access: | https://www.frontiersin.org/article/10.3389/fphar.2018.01407/full |
id |
doaj-76aa011f72c740109b9ec5ce06cfade5 |
---|---|
record_format |
Article |
spelling |
doaj-76aa011f72c740109b9ec5ce06cfade52020-11-24T21:12:15ZengFrontiers Media S.A.Frontiers in Pharmacology1663-98122018-12-01910.3389/fphar.2018.01407418714The South African Regulatory System: Past, Present, and FutureAndrea Keyter0Andrea Keyter1Shabir Banoo2Shabir Banoo3Sam Salek4Stuart Walker5Stuart Walker6Department of Pharmacy, Pharmacology and Postgraduate Medicine, School of Life and Medical Sciences, University of Hertfordshire, Hatfield, United KingdomDepartment of Health, South African Health Products Regulatory Authority, Pretoria, South AfricaDepartment of Health, South African Health Products Regulatory Authority, Pretoria, South AfricaDepartment of Pharmacy and Pharmacology, University of the Witwatersrand, Johannesburg, South AfricaDepartment of Pharmacy, Pharmacology and Postgraduate Medicine, School of Life and Medical Sciences, University of Hertfordshire, Hatfield, United KingdomDepartment of Pharmacy, Pharmacology and Postgraduate Medicine, School of Life and Medical Sciences, University of Hertfordshire, Hatfield, United KingdomCentre for Innovation in Regulatory Science, London, United KingdomThe drive for improved regulatory systems and the establishment of a more effective regulatory framework in South Africa has been evident for the past two decades but despite political intentions and legislative revisions success has been limited to date. Efforts to address the increasing volume of applications that have been received have to date failed and resources have been stretched to capacity resulting in the development of a significant backlog and extended timelines for product registration. The promulgation of the recently amended Medicines and Related Substance Act of 1965 triggered the establishment of the South African Health Products Regulatory Authority (SAHPRA) as a separate juristic person outside of the National Department of Health to replace the former medicine regulatory authority the Medicines Control Council (MCC). The aim of this review is to provide the historical context supporting the new regulatory environment in South Africa and the transition from the MCC to SAHPRA. Key recommendations to SAHPRA to ensure the full potential of the new regulatory environment in South Africa include: establishing a quality management system to safeguard accountability, consistency and transparency and to streamline the implementation of good review practices including quality decision-making practices and benefit-risk assessment; the measurement and monitoring of regulatory performance, targets for overall approval time and key review milestones to instill a culture of accurate metrics collection and measurement of key performance indicators and their continuous improvement and the employment of a risk-based approach to the evaluation of medical products and codify the use of facilitated regulatory pathways in policy and culture. The application of a risk-based approach to regulatory review commensurate with a product’s risk to patients will facilitate the application of increased resources for pharmacovigilance activities and to support the reliance and recognition of reference agencies.https://www.frontiersin.org/article/10.3389/fphar.2018.01407/fullSouth African Health Products Regulatory Authority (SAHPRA)Medicines Control CouncilMCClegislationrisk-based review |
collection |
DOAJ |
language |
English |
format |
Article |
sources |
DOAJ |
author |
Andrea Keyter Andrea Keyter Shabir Banoo Shabir Banoo Sam Salek Stuart Walker Stuart Walker |
spellingShingle |
Andrea Keyter Andrea Keyter Shabir Banoo Shabir Banoo Sam Salek Stuart Walker Stuart Walker The South African Regulatory System: Past, Present, and Future Frontiers in Pharmacology South African Health Products Regulatory Authority (SAHPRA) Medicines Control Council MCC legislation risk-based review |
author_facet |
Andrea Keyter Andrea Keyter Shabir Banoo Shabir Banoo Sam Salek Stuart Walker Stuart Walker |
author_sort |
Andrea Keyter |
title |
The South African Regulatory System: Past, Present, and Future |
title_short |
The South African Regulatory System: Past, Present, and Future |
title_full |
The South African Regulatory System: Past, Present, and Future |
title_fullStr |
The South African Regulatory System: Past, Present, and Future |
title_full_unstemmed |
The South African Regulatory System: Past, Present, and Future |
title_sort |
south african regulatory system: past, present, and future |
publisher |
Frontiers Media S.A. |
series |
Frontiers in Pharmacology |
issn |
1663-9812 |
publishDate |
2018-12-01 |
description |
The drive for improved regulatory systems and the establishment of a more effective regulatory framework in South Africa has been evident for the past two decades but despite political intentions and legislative revisions success has been limited to date. Efforts to address the increasing volume of applications that have been received have to date failed and resources have been stretched to capacity resulting in the development of a significant backlog and extended timelines for product registration. The promulgation of the recently amended Medicines and Related Substance Act of 1965 triggered the establishment of the South African Health Products Regulatory Authority (SAHPRA) as a separate juristic person outside of the National Department of Health to replace the former medicine regulatory authority the Medicines Control Council (MCC). The aim of this review is to provide the historical context supporting the new regulatory environment in South Africa and the transition from the MCC to SAHPRA. Key recommendations to SAHPRA to ensure the full potential of the new regulatory environment in South Africa include: establishing a quality management system to safeguard accountability, consistency and transparency and to streamline the implementation of good review practices including quality decision-making practices and benefit-risk assessment; the measurement and monitoring of regulatory performance, targets for overall approval time and key review milestones to instill a culture of accurate metrics collection and measurement of key performance indicators and their continuous improvement and the employment of a risk-based approach to the evaluation of medical products and codify the use of facilitated regulatory pathways in policy and culture. The application of a risk-based approach to regulatory review commensurate with a product’s risk to patients will facilitate the application of increased resources for pharmacovigilance activities and to support the reliance and recognition of reference agencies. |
topic |
South African Health Products Regulatory Authority (SAHPRA) Medicines Control Council MCC legislation risk-based review |
url |
https://www.frontiersin.org/article/10.3389/fphar.2018.01407/full |
work_keys_str_mv |
AT andreakeyter thesouthafricanregulatorysystempastpresentandfuture AT andreakeyter thesouthafricanregulatorysystempastpresentandfuture AT shabirbanoo thesouthafricanregulatorysystempastpresentandfuture AT shabirbanoo thesouthafricanregulatorysystempastpresentandfuture AT samsalek thesouthafricanregulatorysystempastpresentandfuture AT stuartwalker thesouthafricanregulatorysystempastpresentandfuture AT stuartwalker thesouthafricanregulatorysystempastpresentandfuture AT andreakeyter southafricanregulatorysystempastpresentandfuture AT andreakeyter southafricanregulatorysystempastpresentandfuture AT shabirbanoo southafricanregulatorysystempastpresentandfuture AT shabirbanoo southafricanregulatorysystempastpresentandfuture AT samsalek southafricanregulatorysystempastpresentandfuture AT stuartwalker southafricanregulatorysystempastpresentandfuture AT stuartwalker southafricanregulatorysystempastpresentandfuture |
_version_ |
1716751125494890496 |