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Scientific guidelines (human and veterinary)
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Last updated about 1 month ago
Concept Paper on the revision of Annex 3 of the guidelines on Good Manufacturing Practice for Radiopharmaceuticals
about 1 month ago
Concept Paper on the revision of Annex 3 of the guidelines on...
Guideline on the clinical investigation of medicinal products in the treatment of patients with acute respiratory distress syndrome - Revision 2
about 1 month ago
Guideline on the clinical investigation of medicinal products in the treatment of...
ICH E22 Guideline on general considerations for patient preference studies - Step 2b
about 1 month ago
ICH E22 Guideline on general considerations for patient preference studies - Step...
Guideline on stability testing for applications for variations to a marketing authorisation - Revision 3
about 1 month ago
Guideline on stability testing for applications for variations to a marketing authorisation...
Questions and answers on post approval change management protocols (PACMP) - Revision 1
about 1 month ago
Questions and answers on post approval change management protocols (PACMP) - Revision...
Draft guideline on quality of radiopharmaceuticals - Revision 2
about 1 month ago
Draft guideline on quality of radiopharmaceuticals - Revision 2
Guideline on the development and manufacture of synthetic peptides
about 1 month ago
Guideline on the development and manufacture of synthetic peptides
Concept paper on the guideline revision on good pharmacogenomic practice
about 1 month ago
Concept paper on the guideline revision on good pharmacogenomic practice
All languages - Annex to the European Commission guideline on ‘Excipients in the labelling and package leaflet of medicinal products for human use’ (SANTE-2017-11668) - Revision 5
about 1 month ago
All languages - Annex to the European Commission guideline on ‘Excipients in...
Explanatory note on the withdrawal of the interim guidance on enhanced safety surveillance for seasonal influenza vaccines in the EU
about 1 month ago
Explanatory note on the withdrawal of the interim guidance on enhanced safety...
Concept paper on the need for revision of the guideline on clinical investigation of medicinal products in the treatment of Parkinson’s disease
about 2 months ago
Concept paper on the need for revision of the guideline on clinical...
Procedural advice for vaccine platform technology master file (vPTMF) certification
about 2 months ago
Procedural advice for vaccine platform technology master file (vPTMF) certification