Following consultation with relevant industry groups, TGA, the Australian Therapeutic Goods Administration, has announced the adoption of a number of EU/ICH guidelines in Australia, effective 1 June 2013.
These include, inter alia:
- Guideline on plasma-derived medicinal products (EMA)
- Guideline on active substance master file procedure (EMA)
- Guideline on bioanalytical method validation (EMA)
- Impurities: Guideline for residual solvents ICHQ3C(R5)
Source:
TGA: Newsroommehr
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