Regulatory crackdown on stem cell therapy: What would the position be in South Africa?

South African Medical Journal

Volumn 102, Issue 4, 2012, Pages 219-220

  Jordaan, Donrich W ^a  

^a UNIVERSITY OF CAPE TOWN   (South Africa)

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; AUTOLOGOUS STEM CELL TRANSPLANTATION; GOVERNMENT REGULATION; HUMAN; MEDICOLEGAL ASPECT; SOUTH AFRICA; STEM CELL TRANSPLANTATION;

HUMANS; LEGISLATION, DRUG; SOUTH AFRICA; STEM CELL TRANSPLANTATION; TRANSPLANTATION, AUTOLOGOUS; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 84859166962     PISSN: 02569574     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (13)

1. Eisner W. 'FDA Hauls Regenexx Into Court.' Orthopedics This Week. 18 August 2010. http://ryortho.com/fda.php?news=686_FDA-Hauls-Regenexx-Into-Court (accessed 20 December 2011).
2. FDA. Letter to Regenerative Sciences, Inc. 25 July 2008. http://www.docstoc.com/docs/1046270/FDAUntitled-Letter-to-Regenexx-%28Regenerative-Sciences-Inc---RSI%29 (accessed 20 December 2011).
3. Centeno CJ. Should autologous stem cells be regulated the same as mass produced drugs? (Abstract of a presentation to the Tissue Engineering and Regenerative Medicine Society, December 2010.) http://www.regenexx.com/tag/fda/ (accessed 20 December 2011).
4. Act 101 of 1965.
5. MCC. Guidance Document: Good Manufacturing Practice for Medicines in South Africa. Pretoria: Government Gazette, 2 May 2003.
6. MCC. General Information document for human medicines. http://www.mccza.com/dynamism/default_dynamic.asp?grpID=28&doc=dynamic_generated_page.asp&categID=172&groupID=28 (accessed 20 December 2011).
7. Note that the terms 'biological', biological medicinal product' and 'biological medicine' are used interchangeable in the Guidance Document: Good Manufacturing Practice for Medicines in South Africa. The General Information document consistently employs the term 'biological medicine'.
8. Notice in terms of s14(2) of the Medicines Act published in the Government Gazette of 21 September 1984.
9. Prince v President of the Law Society of the Cape of Good Hope and Others 2000 (3) SA 845 (SCA); 2000 (7) BCLR 823 (SCA) para 12.
10. See for example: Reitzer Pharmaceuticals (Pty) Ltd v Registrar of Medicines and Another 1998 (4) SA 660 (T); Treatment Action Campaign and Another v Rath and Others [2008] ZAWCHC 34; [2008] 4 All SA 360 (C).
11. MCC. Registration of Medicines: General Information. Accessible online at: http://www.mccza.com/genericDocuments/2.01_General_information_Mar11_v7_track_changes.doc (accessed 20 December 2011).
12. Act 65 of 1983.
13. Pepper MS. 'Cell-based therapy navigating troubled waters.' S Afr Med J 2010;100:286-288.