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Scientific guidelines (human and veterinary)
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Last updated about 11 hours ago
Concept paper on the revision of the guideline on dossier requirements for anticancer medicinal products for dogs and cats
about 11 hours ago
Concept paper on the revision of the guideline on dossier requirements for...
Paliperidone palmitate depot suspension for injection (every 3 months) 175, 263, 350 and 525 mg product-specific bioequivalence guidance
about 12 hours ago
Paliperidone palmitate depot suspension for injection (every 3 months) 175, 263, 350...
Concept paper on the revision of the guideline on veterinary medicinal products controlling Varroa destructor parasitosis in bees
about 12 hours ago
Concept paper on the revision of the guideline on veterinary medicinal products...
Concept paper for the revision of the guideline on the conduct of bioequivalence studies for veterinary medicinal products (EMA/CVMP/016/2000-Rev.4)
about 15 hours ago
Concept paper for the revision of the guideline on the conduct of...
Concept paper on the revision of the guideline on user safety for pharmaceutical veterinary medicinal products (EMA/CVMP/543/03-Rev.1)
about 15 hours ago
Concept paper on the revision of the guideline on user safety for...
Tolvaptan tablets with the dose range 7.5, 15 and 30 mg and tolvaptan tablets with the dose range 15, 30, 45, 60 and 90 mg product-specific bioequivalence guidance
about 15 hours ago
Tolvaptan tablets with the dose range 7.5, 15 and 30 mg and...
Draft guideline on the chemistry of active substances - Revision 1
1 day ago
Draft guideline on the chemistry of active substances - Revision 1
Draft guideline on the development and manufacture of oligonucleotides
5 days ago
Draft guideline on the development and manufacture of oligonucleotides
Addendum to the Guideline on clinical development of vaccines to address clinical trials in immunocompromised individuals
8 days ago
Addendum to the Guideline on clinical development of vaccines to address clinical...
Draft VICH GL23 Studies to evaluate the safety of residues of veterinary drugs in human food: genotoxicity testing - Revision 2
22 days ago
Draft VICH GL23 Studies to evaluate the safety of residues of veterinary...
Concept paper on the need for revision of the guideline on clinical investigation of medicinal products for the treatment of psoriatic arthritis
26 days ago
Concept paper on the need for revision of the guideline on clinical...
Draft guideline on the conduct of efficacy studies for intramammary products for use in cattle
29 days ago
Draft guideline on the conduct of efficacy studies for intramammary products for...