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Regulatory and procedural guidelines (human and veterinary)
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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)...
Combined Veterinary Dictionary for Drug Regulatory Activities (VeDDRA) list of clinical terms for reporting suspected adverse reactions in animals and humans to veterinary medicinal products (Excel)
2 months ago
Combined Veterinary Dictionary for Drug Regulatory Activities (VeDDRA) list of clinical terms...
Product Management Services (PMS) - Implementation of International Organization for Standardization (ISO) standards for the identification of medicinal products (IDMP) in Europe - Chapter 2
3 months ago
Product Management Services (PMS) - Implementation of International Organization for Standardization (ISO)...
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 -...
Rules for the implementation of Council Regulation (EC) No 297/95 on fees payable to the European Medicines Agency and other measures - Revised implementing rules to the Fee Regulation as of 28 January 2022
3 months ago
Rules for the implementation of Council Regulation (EC) No 297/95 on fees...
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