.Coming into Effect

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1st June 2020

EMA Scientific guideline: Guideline on clinical investigation of medicinal products for the treatment of gout, adopted.


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1st July 2020

EMA Scientific guideline: Guideline on assessment and control of DNA reactive (mutagenic) impurities in veterinary medicinal products, adopted.


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30th July 2020

EMA Scientific guideline: ICH S5 (R3) guideline on reproductive toxicology: Detection of toxicity to reproduction for human pharmaceuticals, Step 5, adopted.

EMA Scientific guideline: ICH E9 (R1) addendum on estimands and sensitivity analysis in clinical trials to the guideline on statistical principles for clinical trials, Step 5, adopted.