WHAT IS

A number of government strategies and policies to support further growth of the health industry have been developed and adopted. The key to the future growth of this industry is the Bio-economy Strategy of the Department of Science & Technology. This strategy puts health Biotechnology as one of the key pillars. The Bio-Economy Strategy identifies several strengths of the local Health Biotech sector that will drive the bio-economy. These include:

  • A well-developed generics industry.

  • Opportunities for local manufacturing due to improving public- and private-sector focus on generics supply chain management.

  • The largest market in the world (by volume) for HIV drugs.

  • Modern science, local biodiversity, and indigenous knowledge systems could be combined to accelerate product development.

  • World-class clinical sciences researchers and a regulatory framework provide opportunities for globally competitive clinical development.

  • World-class researchers in basic sciences, drug, and diagnostics discovery, and therapeutic delivery systems.

  • Significant investments in vaccine production.

  • Strategic international partnerships with countries and organizations.

 

PROGRAMMES IN SOUTH AFRICA

REVISION OF THE BIOTECHNOLOGY STRATEGY FOR GAUTENG TO BE ALIGNED WITH THE NATIONAL BIO-ECONOMY STRATEGY


The aim of this project is to review the 2007 Gauteng Biotechnology Strategy to evaluate its impact and relevance; revise and align the strategy with the National Bio-economy Strategy; enhance the competitiveness of Bio-economy sectors through research and innovation; enable the Gauteng Department of Agriculture and Rural Development (GDARD). The further aim is to “strengthen agricultural biosciences innovation to ensure food security, enhance nutrition and improve health, as well as enable job creation through the expansion and intensification of sustainable agricultural production and processing” in alignment with the objective of the National Bio-economy Strategy. This will impact the support of GDARD in achieving its vision of “vibrant, equitable, sustainable rural communities, food security for all, protected and enhanced environmental assets, and natural resources” thereby addressing the South African National Development Plan Mid-Term Strategic Framework (NDP MTSF) outcomes 7 and 1.




FEASIBILITY STUDY TO EXAMINE EXISTING MARKETS AND POTENTIAL MARKET DEMAND FOR NEW AND UNDERUTILISED CROPS AND VALUE ADDITION


FEASIBILITY STUDY TO EXAMINE EXISTING MARKETS AND POTENTIAL MARKET DEMAND FOR NEW AND UNDERUTILISED CROPS AND VALUE ADDITION
The aim of this project is to conduct a feasibility study to examine the existing markets and potential market demand for new and underutilised crops including their value addition. Results from the market analysis will provide information and recommendations to direct R&D investment in agricultural infrastructure that can facilitate value addition and agro-processing. It is envisaged that this exercise will enable the Department of Science and Technology (DST) to make informed decisions on where to direct funding resources. The feasibility study in this area will assist in fulfilling the Bio-economy Agricultural Implementation Plan targets.





PROJECTS

 

REVISION OF THE BIOTECHNOLOGY STRATEGY FOR GAUTENG TO BE ALIGNED WITH THE NATIONAL BIO-ECONOMY STRATEGY


The aim of this project is to review the 2007 Gauteng Biotechnology Strategy to evaluate its impact and relevance; revise and align the strategy with the National Bio-economy Strategy; enhance the competitiveness of Bio-economy sectors through research and innovation; enable the Gauteng Department of Agriculture and Rural Development (GDARD). The further aim is to “strengthen agricultural biosciences innovation to ensure food security, enhance nutrition and improve health, as well as enable job creation through the expansion and intensification of sustainable agricultural production and processing” in alignment with the objective of the National Bio-economy Strategy. This will impact the support of GDARD in achieving its vision of “vibrant, equitable, sustainable rural communities, food security for all, protected and enhanced environmental assets, and natural resources” thereby addressing the South African National Development Plan Mid-Term Strategic Framework (NDP MTSF) outcomes 7 and 1.




FEASIBILITY STUDY TO EXAMINE EXISTING MARKETS AND POTENTIAL MARKET DEMAND FOR NEW AND UNDERUTILISED CROPS AND VALUE ADDITION


FEASIBILITY STUDY TO EXAMINE EXISTING MARKETS AND POTENTIAL MARKET DEMAND FOR NEW AND UNDERUTILISED CROPS AND VALUE ADDITION
The aim of this project is to conduct a feasibility study to examine the existing markets and potential market demand for new and underutilised crops including their value addition. Results from the market analysis will provide information and recommendations to direct R&D investment in agricultural infrastructure that can facilitate value addition and agro-processing. It is envisaged that this exercise will enable the Department of Science and Technology (DST) to make informed decisions on where to direct funding resources. The feasibility study in this area will assist in fulfilling the Bio-economy Agricultural Implementation Plan targets.





 


REGULATORY MATTERS

The biotech sector is one of the most carefully regulated industries in the world. Biotech products have to meet an exhaustive series of regulatory requirements to ensure environmental and human safety before they are released into the market.

The regulation of health innovations derived from genetically modified organisms also follows the route of approval by the Executive Council on GMO Act, as it is with agricultural biotech innovation. This is in addition to the approval and registration that is regulated by the Medicines Control Council.

 

The MCC, in considering whether a medicine is suitable for use for its intended purpose, assesses its relative risk against the benefits. The Medicines and Related Substances Act, 1965 (Act 101 of 1965), defines a medicine as any substance or mixtures of substances used or purporting to be suitable for use or manufacture or sold for use in -:

  1. the diagnosis, treatment, mitigation, modification, or prevention of a disease, abnormal physical or mental state, or the symptoms thereof in humans, or

  2. restoring, correcting, or modifying any somatic or psychic or organic function in humans, and includes any veterinary medicine.

 

All medicines for human use are subject to this law, including complementary and complementary biological medicines. Further, all veterinary medicines must be registered in terms of the Act, excluding stock remedies registered in terms of Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act No. 36 of 1947.

 

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