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Scientific guidelines (human and veterinary)

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Latest posts

Last updated 18 days ago

Guideline on safety and efficacy data requirements for 4 applications for immunological veterinary medicinal 5 products intended for limited markets but not eligible 6 for authorisation under Article 23 of Regulation (EU) 7 2019/6

18 days ago

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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

18 days ago

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Guideline on quality data requirements for applications for biological veterinary medicinal products intended for limited markets

18 days ago

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Draft guideline on clinical investigation of medicinal products in the treatment of depression - Revision 3

26 days ago

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DRAFT qualification opinion for GFR slope as a Surrogate Endpoint in RCT for CKD

27 days ago

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Concept paper on the development of a Reflection Paper on modern manufacturing techniques used for herbal preparations

about 2 months ago

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Reflection paper on the use of Artificial Intelligence (AI) in the medicinal product lifecycle

3 months ago

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Guideline for the notification of serious breaches of Regulation (EU) No 536/2014 or the clinical trial protocol

3 months ago

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Concept paper for the revision of the guideline on live recombinant vector vaccines for veterinary use

3 months ago

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Concept paper on the development of a guideline on the quality aspects of mRNA vaccines

3 months ago

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Guideline on the reporting of antimicrobial sales and use in animals at the EU level – denominators and indicators

3 months ago

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Guideline on the development and data requirements of potency tests for veterinary cell-based therapy products and the relation to clinical efficacy

3 months ago

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Scientific guidelines (human and veterinary)

Latest posts

Guideline on safety and efficacy data requirements for 4 applications for immunological veterinary medicinal 5 products intended for limited markets but not eligible 6 for authorisation under Article 23 of Regulation (EU) 7 2019/6

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

Guideline on quality data requirements for applications for biological veterinary medicinal products intended for limited markets

Draft guideline on clinical investigation of medicinal products in the treatment of depression - Revision 3

DRAFT qualification opinion for GFR slope as a Surrogate Endpoint in RCT for CKD

Concept paper on the development of a Reflection Paper on modern manufacturing techniques used for herbal preparations

Reflection paper on the use of Artificial Intelligence (AI) in the medicinal product lifecycle

Guideline for the notification of serious breaches of Regulation (EU) No 536/2014 or the clinical trial protocol

Concept paper for the revision of the guideline on live recombinant vector vaccines for veterinary use

Concept paper on the development of a guideline on the quality aspects of mRNA vaccines

Guideline on the reporting of antimicrobial sales and use in animals at the EU level – denominators and indicators

Guideline on the development and data requirements of potency tests for veterinary cell-based therapy products and the relation to clinical efficacy

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