News
EMEA: Overview of comments received on draft guideline on Carcinogenicity Evaluation of Medicinal Products for the Treatment of HIV Infection
25.03.2009
EMEA:
Overview of comments received on draft guideline on Carcinogenicity Evaluation of Medicinal Products for the Treatment of HIV Infection. This overview contains the general comments ...
Overview of comments received on draft guideline on Carcinogenicity Evaluation of Medicinal Products for the Treatment of HIV Infection. This overview contains the general comments ...
EMEA: Guideline on Clinical Investigation of Human Normal Immunoglobulin for Intravenous Administration (IVIg)
25.03.2009
EMEA:
Guideline on Clinical Investigation of Human Normal Immunoglobulin for Intravenous Administration (IVIg). This Guideline describes the information to be documented when an ...
Guideline on Clinical Investigation of Human Normal Immunoglobulin for Intravenous Administration (IVIg). This Guideline describes the information to be documented when an ...
EMEA: Guideline for Core SmSPC for Human Normal Immunoglobulin (IVIg) for Intravenous administration
25.03.2009
EMEA:
Guideline for Core SmSPC for Human Normal Immunoglobulin (IVIg) for Intravenous administration. This Guideline describes the information to be included in the Summary of Product ...
Guideline for Core SmSPC for Human Normal Immunoglobulin (IVIg) for Intravenous administration. This Guideline describes the information to be included in the Summary of Product ...
EMEA: Concept Paper on Revision of the EU Guideline on Good Distribution Practice (GDP)
25.03.2009
EMEA:
Concept Paper on Revision of the EU Guideline on Good Distribution Practice (GDP).
This concept paper addresses the need to update the Guideline on Good Distribution Practice ...
Concept Paper on Revision of the EU Guideline on Good Distribution Practice (GDP).
This concept paper addresses the need to update the Guideline on Good Distribution Practice ...
EMEA: Corrected HMPC assessment reports\' on: Verbasci flos Verbascum sp., flos (mullein flower)
25.03.2009
EMEA:
Corrected HMPC assessment reports\' on: Verbasci flos Verbascum sp., flos (mullein flower). ...
Corrected HMPC assessment reports\' on: Verbasci flos Verbascum sp., flos (mullein flower). ...
EMEA: Dossier requirements in the centralised procedure
25.03.2009
EMEA:
Dossier requirements for Post-authorisation submissions in the centralised procedure. ...
Dossier requirements for Post-authorisation submissions in the centralised procedure. ...
EMEA: Concept Paper on the Implementation of ICH Q10
25.03.2009
EMEA:
Concept Paper on the Implementation of ICH Q10. This Concept Paper outlines a proposal to implement ICH Q10 (Pharmaceutical Quality System) in the EU (Step 5 of the ICH process). ...
Concept Paper on the Implementation of ICH Q10. This Concept Paper outlines a proposal to implement ICH Q10 (Pharmaceutical Quality System) in the EU (Step 5 of the ICH process). ...
EMEA: The e-submission roadmap of veterinary medicinal products documents
25.03.2009
EMEA:
The e-submission roadmap of veterinary medicinal products documents. The initiative to create a veterinary sub-group of the Telematics Implementation Group on electronic submission ...
The e-submission roadmap of veterinary medicinal products documents. The initiative to create a veterinary sub-group of the Telematics Implementation Group on electronic submission ...
EMEA: 2008 public status report on the implementation of the European Risk Management Strategy
25.03.2009
EMEA:
2008 public status report on the implementation of the European Risk Management Strategy. The European Risk Management Strategy (ERMS) is a joint EMEA – Heads of Medicines ...
2008 public status report on the implementation of the European Risk Management Strategy. The European Risk Management Strategy (ERMS) is a joint EMEA – Heads of Medicines ...
EMEA: Draft guideline on the conduct of bioequivalence studies for veterinary medicinal products
25.03.2009
EMEA:
Draft guideline on the conduct of bioequivalence studies for veterinary medicinal products. The aim of this guideline is to provide guidance regarding study design, conduct and ...
Draft guideline on the conduct of bioequivalence studies for veterinary medicinal products. The aim of this guideline is to provide guidance regarding study design, conduct and ...