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Scientific guidelines (human and veterinary)
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Last updated 4 days ago
Guideline on good pharmacovigilance practices (GVP) - Module XVI Addendum I – Risk minimisation measures for medicinal products with embryo-fetal risks
19 days ago
Guideline on good pharmacovigilance practices (GVP) - Module XVI Addendum I –...
Concept paper on the need for revision of the guideline on the clinical investigation of medicines for the treatment of Alzheimer's disease
about 1 month ago
Concept paper on the need for revision of the guideline on the...
Fingolimod capsules 0.25 and 0.5 mg product-specific bioequivalence guidance
about 2 months ago
Fingolimod capsules 0.25 and 0.5 mg product-specific bioequivalence guidance
Guideline on the requirements for demonstrating therapeutic equivalence between orally inhaled products (OIP) for asthma and chronic obstructive pulmonary disease (COPD) - Revision 2
about 2 months ago
Guideline on the requirements for demonstrating therapeutic equivalence between orally inhaled products...
Guideline on the pharmaceutical quality of inhalation and nasal medicinal products - Revision 1
about 2 months ago
Guideline on the pharmaceutical quality of inhalation and nasal medicinal products -...
Dronedarone film-coated tablets 400 mg product-specific bioequivalence guidance - Revision 1
2 months ago
Dronedarone film-coated tablets 400 mg product-specific bioequivalence guidance - Revision 1
Ledipasvir/sofosbuvir film-coated tablet 45 mg/200 mg and 90 mg/400 mg, coated granules 33.75mg/150mg and 45mg/200mg product-specific bioequivalence guidance - Revision 1
2 months ago
Ledipasvir/sofosbuvir film-coated tablet 45 mg/200 mg and 90 mg/400 mg, coated granules...
Paracetamol oral use immediate release formulations product-specific bioequivalence guidance - Revision 2
3 months ago
Paracetamol oral use immediate release formulations product-specific bioequivalence guidance - Revision 2
Posaconazole oral suspension 40 mg/ml product-specific bioequivalence guidance - Revision 1
3 months ago
Posaconazole oral suspension 40 mg/ml product-specific bioequivalence guidance - Revision 1
ICH E20 guideline on adaptive designs for clinical trials - Step 2b
3 months ago
ICH E20 guideline on adaptive designs for clinical trials - Step 2b
Concept paper on the need for revision of note for guidance on quality aspects of pharmaceutical veterinary medicines for administration via drinking water
3 months ago
Concept paper on the need for revision of note for guidance on...
Concept paper for the development of a guideline on the methodology of environmental risk assessment for ectoparasiticidal VMPs for cats and dogs
3 months ago
Concept paper for the development of a guideline on the methodology of...