Life & Biosciences

The South African regulatory regime specific to the life sciences sector is extensive. It is important for a start-up with business interests and/or activity relevant to the life sciences sector, to identify the applicable regulatory context and consult the applicable regulatory bodies. Specific regulatory guidelines can be found for the following:

• General, Ectd & Human Medicines

• Complementary

• Inspectorate And Good Manufacturing Practices

• Medical Devices And In Vitro Diagnostics

• Veterinary Medicines

• Names And Scheduling

• Regulatory Compliance

• Clinical Trials

• Radiation Control

• Vigilance Guidelines

• Biologicals

• Unregistered Products.

Activities involving Genetically Modified Organisms (GMOs) are likewise extensively regulated, falling within the scope of several ministries and regulatory bodies.

South Africa’s policy and legislative framework for biodiversity is well developed, providing a strong basis for the conservation and sustainable use of biodiversity. South Africa is one of the few countries in the world to have a Biodiversity Act and a National Biodiversity Institute.
Key components of the national policy and legislative framework for biodiversity include:

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• The White Paper on the Conservation and Sustainable Use of South Africa’s Biological Diversity (1997)

• The National Environmental Management: Biodiversity Act (Act 10 of 2004)

• The National Environmental Management: Protected Areas Act (Act 57 of 2003)

• The National Biodiversity Strategy and Action Plan (NBSAP) (2005)

• The National Spatial Biodiversity Assessment (NSBA) (2004, currently being reviewed and updated)

• The National Biodiversity Framework (NBF) (2008)

• The National Protected Area Expansion Strategy (NPAES) (2008).

In addition to national legislation, some of South Africa’s nine provinces have their own provincial biodiversity legislation, as nature conservation is a concurrent function of national and provincial government in terms of the Constitution (Act 108 of 1996).