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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

Pilot programme: European Medicines Agency-Food and Drug Administration parallel scientific advice for hybrid/complex generic products - General principles

11 days ago

Pilot programme: European Medicines Agency-Food and Drug Administration parallel scientific advice for...

Dissemination guidelines for training materials: CTIS training programme

about 2 months ago

Dissemination guidelines for training materials: CTIS training programme

Non-current Veterinary Dictionary for Drug Regulatory Activities (VeDDRA) low level terms (LLT) and codes

about 2 months ago

Non-current Veterinary Dictionary for Drug Regulatory Activities (VeDDRA) low level terms (LLT)...

Non-current Veterinary Dictionary for Drug Regulatory Activities (VeDDRA) low level terms (LLT) and codes

2 months ago

Non-current Veterinary Dictionary for Drug Regulatory Activities (VeDDRA) low level terms (LLT)...

Guideline on the summary of product characteristics (SPC) for veterinary medicinal products containing antimicrobial substances - Revision 1

3 months ago

Guideline on the summary of product characteristics (SPC) for veterinary medicinal products...

Procedural guidance for variant strain(s) update to vaccines intended for protection against human coronavirus

3 months ago

Procedural guidance for variant strain(s) update to vaccines intended for protection against...

ICH guideline S12 on nonclinical biodistribution considerations for gene therapy products - Step 2b

3 months ago

ICH guideline S12 on nonclinical biodistribution considerations for gene therapy products -...

Draft guideline on computerised systems and electronic data in clinical trials

3 months ago

Draft guideline on computerised systems and electronic data in clinical trials

Validation checklist for Type II quality variations

4 months ago

Validation checklist for Type II quality variations