Under which circumstances, the applicant need to provide full report of carcinogenicity study for a new molecular entity marketing authorization?

刊登日期:2019-11-12  |  點閱次數 : 340 次 

Based on ICH S1 Guidelines, carcinogenicity studies need to be completed and provided the study data before marketing approval for pharmaceuticals as below:

  1. Any pharmaceutical whose expected clinical use is continuous for at least 6 months or repeatedly in an intermittent manner at least 6 months.
  2. Previous demonstration of carcinogenic potential is in the product class that is considered relevant to human.
  3. The mechanism of action or structure-activity relationship suggesting carcinogenic risk.
  4. Evidence of preneoplastic lesions in repeated dose toxicity studies.
  5. Long-term tissue retention of parent compound or metabolite(s) resulting in local tissue reactions or other pathophysiological responses.
  6. The pharmaceutical presenting mutagenic potential in genotoxicity study results.

When the compound is limited to treat certain specific disease and demonstrating the clinical benefits in patients, carcinogenicity testing can be concluded post-approval. The complete carcinogenicity studies need not be provide during the clinical trial periods unless extra concerns appear. In instances where the life-expectancy in the indicated population is short (i.e., less than 2 - 3 years), no long-term carcinogenicity studies may be required.



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