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Scientific guidelines (human and veterinary)
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Last updated 15 days ago
Reflection paper on use of real-world data in non-interventional studies to generate real-world evidence
15 days ago
Reflection paper on use of real-world data in non-interventional studies to generate...
Addendum to EMA/CHMP/CVMP/QWP/17760/2009 Rev 3: Defining the Scope of an NIRS Procedure
16 days ago
Addendum to EMA/CHMP/CVMP/QWP/17760/2009 Rev 3: Defining the Scope of an NIRS Procedure
Guideline on stability testing for applications for variations 4 to a marketing authorisation for veterinary medicinal 5 products
16 days ago
Guideline on stability testing for applications for variations 4 to a marketing...
Guideline on stability testing for applications for variations to a marketing authorisation for veterinary medicinal products
16 days ago
Guideline on stability testing for applications for variations to a marketing authorisation...
Concept paper on revision of the Guideline on Risk Assessment of Medicinal Products on Human Reproduction and Lactation: from Data to Labelling
16 days ago
Concept paper on revision of the Guideline on Risk Assessment of Medicinal...
Concept paper for the development of a guideline on the safety of nanoparticles – in the context of the establishment of maximum residue limits and veterinary marketing authorisations
22 days ago
Concept paper for the development of a guideline on the safety of...
Draft guideline on good agricultural and collection practice (GACP) for starting materials of herbal origin - Revision 1
30 days ago
Draft guideline on good agricultural and collection practice (GACP) for starting materials...
Draft guideline on the pharmaceutical quality of inhalation and nasal medicinal products
about 1 month ago
Draft guideline on the pharmaceutical quality of inhalation and nasal medicinal products
Draft guideline on the requirements for demonstrating therapeutic equivalence between orally inhaled products (OIP) for asthma and chronic obstructive pulmonary disease (COPD)
about 1 month ago
Draft guideline on the requirements for demonstrating therapeutic equivalence between orally inhaled...
Draft information for the package leaflet regarding proline used as an excipient in medicinal products for human use
2 months ago
Draft information for the package leaflet regarding proline used as an excipient...
ICH E2D(R1) Guideline on post-approval safety data Step 2b - Revision 1
3 months ago
ICH E2D(R1) Guideline on post-approval safety data Step 2b - Revision 1
Preliminary QIG Considerations regarding Pharmaceutical Process Models
3 months ago
Preliminary QIG Considerations regarding Pharmaceutical Process Models