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LATEST NEWS


Draft regulations for registration of medical devices in South Africa
The South African regulatory authority has revised regulations relating to the registration of medical devices in the country. The draft regulations which were released for comment will significantly change the registration process in the country with a more comprehensive dossier being required for the process. The comment period has now closed. Please see the attached file here.

Complementary and Alternative Medicines Registration in South Africa - Request for review of regulations from industry group
The release in November 2013 of the regulations for registration of Complementary and Alternative Medicines in South Africa has resulted in much debate in the industry. Representations have been made by various groups within the industry to the Medicines Control Council for clarification for amendments to the regulations, a copy of which can be accessed here . Comments can be forwarded to the discussion group directly - details can be found on page 14 of the document.

17th World congress of Basic and Clinical Pharmacology in Cape Town
The Congress will be held from 13-18 July 2014 in Cape Town, South Africa. There is an excellent scientific programme as well as a variety of pre- and post-congress satellite meetings. The Congress will be opened by Nobel Laureate for Chemistry 2012, Dr. Robert Lefkowitz, Professor at Duke University Medical Center, brings together some of the world's leading pharmacologists and is a unique networking opportunity. More information can be found in the attached link or at www.wcp2014.org

FDA: Draft Guidelines for clinical pharmacology data to support biosimilarity
On 9 May 2014, the FDA released for comment a draft guidance for clinical pharmacology data required to demonstrate biosimilarity to a reference product. The Guidance expands on the 2012 document and should provide drug developers a more structured roadmap in the development of biosimilars. The guidance can be accessed here .

And now for something completely different…
Anyone who knows me knows that I'm fascinated by the cosmos and anything that relates to it….. have a look at the YouTube item by Neil deGrasse Tyson on Can fish swim in space? Enjoy Star Trek Radio!

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Useful Links – South Africa

MEDICINES CONTROL COUNCIL (MCC)

http://www.mccza.com/

Clinical trials and registration of orthodox / allopathic medicines are subject to the terms of the Medicines and Related Substances Act; Act 101 of 1965 as amended.

The Medicines Control Council (MCC) is a local statutory body constituted in compliance with Act 101, which regulates the performance of clinical trials and registration of medicines and medical devices in South Africa. The Medicines Regulatory Authority (MRA) is the secretariat to the MCC which coordinates applications and forwards them to the relevant MCC subcommittee to ensure that all clinical trials of both non-registered medicines and new indications of registered medicines comply with the necessary requirements for safety, quality and efficacy.

All clinical trials are conducted in according to the South African equivalent of ICH GCP.

  • Approvals are received approximately 10 working days after the MCC meeting.
  • Scheduled submission cycles and requirements for submissions are available at
    .

NATIONAL HEALTH RESEARCH COMMITTEE

www.nhrc.org.za

The National Health Research Committee (NHRC) is a statutory body established in terms of the National Health Act, 2003.

The National Health Research Committee is tasked with determining the type of research to be carried out by the pubic health authorities and ensuring that health research is focused on priority health problems. The Committee also advises the Minister of Health on national strategies for health research and co-ordinates the research activities of public health authorities.

NATIONAL HEALTH RESEARCH ETHICS COUNCIL

www.nhrec.org.za

The NHREC’s function is to give direction on ethical issues relating to health and in developing guidelines for the conduct of research involving humans in South Africa.  The Council observes and advises on international developments in health ethics issues through liaison with relevant international organisations. The Council also regulates the academic and private research ethics committees in South Africa.  As for the National Health Research Committee, the NHREC is a statutory body established in terms of the National Health Act, 2003

Accreditation by the NHREC is mandatory for all Ethics Committees in South Africa who approve health research in humans.

SOUTH AFRICAN CLINICAL TRIALS REGISTER

www.sanctr.gov.za

The South African Clinical Trials Register (SANCTR) provides the South African public with updated information about clinical trials being conducted in South Africa. In order to fulfil requirements for approval, all clinical trials must be registered on this publicly accessible website.

 

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