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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Draft Guidelines for clinical pharmacology data to support biosimilarity On 9 May 2014, the FDA released for comment a draft guidance for clinical pharmacology data required to demonstrate biosimilarity to a reference product.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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Product Registration:

Depending on the regulatory requirements for each country, the following services are provided:

Assessment of data required for development and registration of pharmaceuticals / complementary medicines and medical devices for Southern and Sub-Saharan African regions (English speaking). Where national requirements require, collaboration with local independent professionals for submission of dossiers.
Submission of amendments and labelling changes.
Regulatory project management to complement in-house regulatory departments in areas such as

preparation of major submissions.
development and/or updating of Standard Operating Procedures (SOPs).

Electronic copies of all correspondence with the regulatory authorities is provided throughout the process to ensure a comprehensive dossier is available in-house at all times.

DRConsulting will work closely with your in-house regulatory affairs team to compile registration dossiers of the highest quality to facilitate approvals in the fastest possible times.


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