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Scientific guidelines (human and veterinary)
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Last updated 23 days ago
Concept paper on the need for revision of the guideline on the clinical investigation of medicines for the treatment of Alzheimer's disease
23 days 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 1 month 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 1 month 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 1 month ago
Guideline on the pharmaceutical quality of inhalation and nasal medicinal products -...
Dronedarone film-coated tablets 400 mg product-specific bioequivalence guidance - Revision 1
about 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
about 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
about 2 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
about 2 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
about 2 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
2 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
2 months ago
Concept paper for the development of a guideline on the methodology of...
Draft chapter 9 of guideline on epidemiological data on blood transmissible infections
2 months ago
Draft chapter 9 of guideline on epidemiological data on blood transmissible infections