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Regulatory and procedural guidelines (human and veterinary)

Get the latest updates from Regulatory and procedural guidelines (human and veterinary) directly as they happen.

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Latest posts

Last updated 11 days ago

Qualification of novel methodologies for drug development: guidance to applicants

11 days ago

Qualification of novel methodologies for drug development: guidance to applicants

European Medicines Agency guidance for companies requesting scientific advice (veterinary)

11 days ago

European Medicines Agency guidance for companies requesting scientific advice (veterinary)

European Medicines Agency guidance for applicants seeking scientific advice and protocol assistance

11 days ago

European Medicines Agency guidance for applicants seeking scientific advice and protocol assistance

Procedural advice to applicants/marketing authorisation holders on re-examination of CVMP opinions

about 2 months ago

Procedural advice to applicants/marketing authorisation holders on re-examination of CVMP opinions

Explanatory note on general fees payable to the European Medicines Agency as of 1 September 2020

about 2 months ago

Explanatory note on general fees payable to the European Medicines Agency as...

European Medicines Agency privacy statement for EnprEMA network database

2 months ago

European Medicines Agency privacy statement for EnprEMA network database

List of substances and products subject to worksharing for signal management

3 months ago

List of substances and products subject to worksharing for signal management

Union Product Database (UPD) Access Policy - Veterinary Medicinal Products - Policy no 0082

4 months ago

Union Product Database (UPD) Access Policy - Veterinary Medicinal Products - Policy...

Veterinary Dictionary for Drug Regulatory Activities (VeDDRA) dataload friendly file including deprecated terms

4 months ago

Veterinary Dictionary for Drug Regulatory Activities (VeDDRA) dataload friendly file including deprecated...