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Scientific guidelines (human and veterinary)

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Last updated 4 days ago

Guideline on in-use stability testing of veterinary medicinal products

13 days ago

Guideline on in-use stability testing of veterinary medicinal products

Draft guideline on the clinical evaluation of medicinal products intended for the treatment of chronic hepatitis B (CHB) - Revision 1

14 days ago

Draft guideline on the clinical evaluation of medicinal products intended for the...

Draft guideline on clinical investigation of medicinal products for the treatment of psoriatic arthritis - Revision 1

14 days ago

Draft guideline on clinical investigation of medicinal products for the treatment of...

Draft guideline on clinical investigation of medicinal products for the treatment of psoriatic arthritis

14 days ago

Draft guideline on clinical investigation of medicinal products for the treatment of...

Concept paper on new guidance on the clinical investigation of medicinal products for the treatment of idiopathic pulmonary fibrosis (IPF)

14 days ago

Concept paper on new guidance on the clinical investigation of medicinal products...

Melatonin prolonged release tablets 2 mg product-specific bioequivalence guidance

19 days ago

Melatonin prolonged release tablets 2 mg product-specific bioequivalence guidance

Fingolimod capsules 0.25 and 0.5 mg product-specific bioequivalence guidance

3 months ago

Fingolimod capsules 0.25 and 0.5 mg product-specific bioequivalence guidance