scholarly journals REGULATORY REQUIREMENTS FOR DRUG PRODUCTS REGISTRATION IN SOUTH AFRICA

2018 ◽  
Vol 3 (4) ◽  
pp. 1-8
Author(s):  
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.

Author(s):  
Nigel Crisp

Chapter 18 describes how Dr Motsoaledi, the South African Health Minister, set about leading the fight on HIV/AIDS in South Africa, and introducing a national health insurance scheme in order to offer healthcare to every person in the country, by building on the work that was already underway. It describes his complex story, with many confusing cross-currents and elements of conflict and intrigue, and how a large part of the Minister’s role involved trying to cut through the confusion, offer a clear pathway for the future, and communicate


2001 ◽  
Vol 57 (2) ◽  
pp. 32-40 ◽  
Author(s):  
L. A. Hale ◽  
C. J. Eales

This paper presents the opinions of expert physiotherapists on what constitutes optimal stroke rehabilitation in South Africa. Data were collected by the use of the Delphi technique. Consensus was reached after two rounds, and the respondents’ views are summarised and discussed within the framework of South African health care. Results showed that physiotherapy was felt to be very important after stroke, and the survey created a profile of the skills that physiotherapists may require in order to work in this field. However, no new or innovative methods by which appropriate rehabilitation services could be delivered in South Africa were generated by the survey.The Delphi technique is described and its use in this survey considered.


2017 ◽  
Vol 9 (4(J)) ◽  
pp. 62-72
Author(s):  
Victor H. Mlambo ◽  
Toyin Cotties Adetiba

While there has been a plethora of studies that addresses migration in Africa, many have yet to successfully unpack the effects of brain drain on the South African health sector. Using textual analysis of the available literature relevant to the topic under consideration; this work seeks to identify the major structural and socio-economic push factors that drive the migration of health professionals in South Africa, relying on Revestain’s laws of migration and Lee’s push/pull theory of migration. The study also looks at explaining other factors that contribute to the migration of health professionals in South Africa. We argue that for South Africa to retain health professionals, the government needs to increase the training of health workers, improve their working conditions and security, upgrade infrastructure and ensure availability of resources as well as develop a more open immigration policy prioritizing skilled immigration.


2017 ◽  
Vol 9 (4) ◽  
pp. 62 ◽  
Author(s):  
Victor H. Mlambo ◽  
Toyin Cotties Adetiba

While there has been a plethora of studies that addresses migration in Africa, many have yet to successfully unpack the effects of brain drain on the South African health sector. Using textual analysis of the available literature relevant to the topic under consideration; this work seeks to identify the major structural and socio-economic push factors that drive the migration of health professionals in South Africa, relying on Revestain’s laws of migration and Lee’s push/pull theory of migration. The study also looks at explaining other factors that contribute to the migration of health professionals in South Africa. We argue that for South Africa to retain health professionals, the government needs to increase the training of health workers, improve their working conditions and security, upgrade infrastructure and ensure availability of resources as well as develop a more open immigration policy prioritizing skilled immigration.


2017 ◽  
Vol 7 (4) ◽  
pp. 1-23
Author(s):  
Ellenore Meyer ◽  
Leena Thomas ◽  
Selma Smith ◽  
Caren Scheepers

Subject area Public Health; Leadership; Organisational Development; Organisational Behaviour; Public Administration Management. Study level/applicability Postgraduate level for honours or masters programmes in courses on public health; executive leadership and management programmes; MBA level. Case overview The case unpacks decentralisation as a means to promote and improve local decision-making and accountability through community participation and engagements. Ayanda Nkele was a programme manager in a health district in South Africa. He was faced with many challenges when trying to implement his programme, most of which were related to local authority, responsibilities and decision-making abilities at his level. This case describes briefly the South African health system. and how it functions. It describes the proposed changes to the health system and its transformation towards Universal Health Coverage. The decision space analysis as discussed in the case illustrates the types of decentralisation in the country and how this also applies to Nkele’s level. Expected learning outcomes Understanding the concepts and principles of decentralisation within the context of strengthening district health services, the re-engineering of primary health care (PHC) and rolling out a National Health Insurance in South Africa. Applying the “decision space” approach to analyse the extent of decentralisation. Grasping the requirement of leaders to be “contextually intelligent” and identify the important contextual variables to take into account when analysing public health care. Supplementary materials Teaching Notes are available for educators only. Please contact your library to gain login details or email [email protected] to request teaching notes. Subject code CSS 7: Management Science.


1996 ◽  
Vol 1 (3) ◽  
pp. 36-40
Author(s):  
Rachael V Gumbi ◽  
Marie E Muller

The education of South African health personnel should be reality-based and therefore focused on the real needs of the country. OpsommingDie opleiding van Suid-Afrikaanse gesondheidspersoneel behoort op die realiteit gebaseer te word en derhalwe op die behoeftes van die land. *Please note: This is a reduced version of the abstract. Please refer to PDF for full text.


Significance President Cyril Ramaphosa on March 15 declared a state of national disaster and announced stringent measures to help combat the outbreak. While South Africa is relatively well equipped to manage the early stages of a crisis, a surge in infections could overwhelm the country’s hospitals. Impacts The crisis has enhanced Ramaphosa’s national reputation, giving him respite from internal ANC opposition with a key party meeting postponed. Efforts to combat COVID-19’s spread will further strain already weak public finances, with a ratings agency downgrade looming. The survival of embattled national carrier South African Airways is in further doubt amid global airline upheaval.


2018 ◽  
Vol 39 (2) ◽  
pp. 127-132
Author(s):  
Terry J. Ellapen ◽  
Yvonne Paul ◽  
Marco Barnard ◽  
Mariette Swanepoel ◽  
Henriette V Hammill ◽  
...  

The mortality of South African noncommunicable diseases (NCDs) is rising. One of its primary contributors is physical inactivity. Therefore, South African National Health Plan included exercise therapy as part of their strategy to inhibit the NCDs upsurge. This study aimed to determine whether the number of South African exercise therapists is sufficient to equitably manage this NCD epidemic. The 2013 and 2017 Health Professions Council of South Africa reports identified the number of physiotherapists, biokineticists, and their respective students-in-training. In 2012, 10,623,820 people were identified with NCDs; however, South African Department of Health only treated 6,058,186 patients (57.0%) ( p < .05). South African Health Review has estimated a 28.7% increase in the number of NCDs patients treated from 2012 (6,058,186) to 2025 (7,799,770) ( p < .05). The average yearly growth of practicing physiotherapists (3.4%) and the physiotherapy student-in-training (2.2%) is inequitable to manage this NCD epidemic. In 2012, the extrapolated physiotherapist-to-NCD patient ratio was 1:5667. The South African Department of Health should consider including biokineticists to aid in the management of the NCD epidemic.


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