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Media Releases

MCC no longer recommends the use of Monotherapy in preventing mother to child transimission of HIV (zipped Ms-Word 187kb)

Nevirapine Press Release 28/07/2003 (Ms-Word 67kb)

Withdrawal of Vioxx (rofecoxib) from the South African Market (PDF 29kb)

Workshops and conferences

Assessing similarity of biosimilars to innovator biopharmaceuticals: A reviewer's perspective - Leng (zipped PDF 561kb)

Biologicals,Biosimilars: A South African Perspective of Registration - Mbelle (zipped PDF 79kb)

Biotech 2007 Summary - Hela (zipped PDF 48kb)

Clinical trials for biotechnology medicines - Southern (zipped PDF 20kb)

Immunogenicity of biopharmaceuticals - Schellekens et al (zipped PDF 160kb)

Issues related to the formulation and delivery of pharmaceutical proteins - Crommelin (zipped PDF 896kb)

Prerequisites for safe and efficacious biological medicinal products, with special reference to "biosimilar" products - Holloway (zipped PDF 338kb)

Regulatory issues and drug product approval for biopharmaceuticals - Shah (zipped PDF 32kb)

Regulatory testing of biological medicines - Vergeer (zipped PDF 468kb)

SADC Harmonisation initiatives - ICH May 2007 (Ms-Powerpoint 77kb)

What are biotechnology products-Crommelin (zipped PDF 1548kb)