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Scientific guidelines (human and veterinary)
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Last updated 14 days ago
Guideline on quality data requirements for applications for biological veterinary medicinal products intended for limited markets
14 days ago
Guideline on quality data requirements for applications for biological veterinary medicinal products...
Concept paper for the revision of the guideline on anticoccidials used for the therapy of coccidiosis in chickens, turkeys and geese
14 days ago
Concept paper for the revision of the guideline on anticoccidials used for...
Guideline on safety and residue data requirements for applications for non-immunological veterinary medicinal products intended for limited markets but not eligible for authorisation under Article 23 of Regulation (EU) 2019/6
14 days ago
Guideline on safety and residue data requirements for applications for non-immunological veterinary...
Guideline on safety and efficacy data requirements for applications for immunological veterinary medicinal products intended for limited markets but not eligible for authorisation under Article 23 of Regulation (EU) 2019/6
14 days ago
Guideline on safety and efficacy data requirements for applications for immunological veterinary...
Questions and answers on data requirements when transitioning to low global warming potential (LGWP) propellants in oral pressurised metered dose inhalers
29 days ago
Questions and answers on data requirements when transitioning to low global warming...
Draft guideline on risk management requirements for elemental impurities in veterinary medicinal products - Revision 3
about 1 month ago
Draft guideline on risk management requirements for elemental impurities in veterinary medicinal...
Reflection paper on the use of Artificial Intelligence (AI) in the medicinal product lifecycle
about 1 month ago
Reflection paper on the use of Artificial Intelligence (AI) in the medicinal...
Reflection paper on establishing efficacy based on single-arm trials submitted as pivotal evidence in a marketing authorisation application
about 2 months ago
Reflection paper on establishing efficacy based on single-arm trials submitted as pivotal...
Questions and answers regarding co-processed excipients used in solid oral dosage forms (H & V)
about 2 months ago
Questions and answers regarding co-processed excipients used in solid oral dosage forms...
Draft guideline on clinical development of medicinal products for the treatment and prevention of bipolar disorder - Revision 1
about 2 months ago
Draft guideline on clinical development of medicinal products for the treatment and...
ICH guideline E11A on pediatric extrapolation Step 5
2 months ago
ICH guideline E11A on pediatric extrapolation Step 5
Guideline on good pharmacovigilance practices: Annex I - Definitions (Rev. 5)
3 months ago
Guideline on good pharmacovigilance practices: Annex I - Definitions (Rev. 5)