03/07/2015
Here in South Africa, not a single natural health product application for registration has been approved under our new regulatory scheme since it came into effect in 2013. Similarly in the UK, applications for herbal products under their new EU prescribed regulatory scheme, also appears to be a slow and painful process.
The regulators appear only interested in approving single ingredient natural health products, and are effectively outlawing complex remedies, citing the lack of product-specific research to motivate them carrying health claims. Such research will cost companies tens of millions of Rands per product to conduct, making it impossible for anyone except BigPharma with deep pockets to comply. The regulators are unable to hammer this square peg (traditional and innovative natural medicine) though their round hole (harmonized CTD pre-marketing authorization system), and patience is wearing thin across the board.
Both the UK and South African medicines regulatory authorities will be heading off to an international regulatory conference in London soon, to discuss the adoption of the Canadian 3rd Category licensing system for Natural Health Products. A system which has also proven to be problematic and currently being challenged in the Canadian Federal Appeals Court.
Last month, Phynova, a life sciences company based in Oxford, UK, announced it had received approval by the UK medicines regulator, the MHRA, of Isatis Cold and Flu Relief. The product is based on the traditional Chinese medicine (TCM) product Ban Lan Gen. Phynova, a life sciences company based in O…