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Income Tax Act, 1962 (Act No. 58 of 1962)

Regulations

Regulations on the additional criteria for clinical trials for the purposes of the deduction for research and development in terms of section 11D of the Income Tax Act, 1962

3. Exclusions in respect of deduction for research and development in respect of a clinical trial

 

 

Despite regulation 2, the following activities do not qualify as research and development in respect of clinical trials being carried on for the purposes of section 11D of the Act:

(a) a phase IV clinical trial, as defined in Appendix F to the Guidelines other than a clinical trial conducted for the purpose of developing new indications, developing new methods of administration or developing new combinations of pharmaceutical products;
(b) post-marketing research;
(c) cost-effectiveness research;
(d) an activity undertaken solely for the purpose of compliance with regulatory requirements;
(e) a product familiarisation program;
(f) research carried on for statistical purposes (meta-analysis);
(g) epidemiological research; or
(h) research activities undertaken in preparation for the registration of a clinical trial.