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EMEA: Public statement on fee reductions for designated orphan medicinal products

16.02.2009
EMEA:
Public statement on fee reductions for designated orphan medicinal products . This includes fees for pre-authorisation activities such as protocol assistance (scientific advice), and ...

EMEA: Draft Guideline on Declaration of Herbal Substances and Herbal Preparations in Herbal Medicinal Products/Traditional Herbal Medicinal Products in the SPC

16.02.2009
EMEA:
Draft Guideline on Declaration of Herbal Substances and Herbal Preparations in Herbal Medicinal Products/Traditional Herbal Medicinal Products in the SPC. This guideline addresses ...

EMEA: Guideline on the Development of Medicinal Products for the Treatment of Post-Traumatic Stress Disorder (PTSD)

16.02.2009
EMEA:
Guideline on the Development of Medicinal Products for the Treatment of Post-Traumatic Stress Disorder (PTSD). This document provides guidance to Marketing Authorisation Applicants ...

EMEA: Concept paper on the need to update the current annex guideline on Cell culture inactivated influenza vaccines with respect to the Derivation of cell-isolated influenza vaccine viruses

16.02.2009
EMEA:
Concept paper on the need to update the current annex guideline on Cell culture inactivated influenza vaccines with respect to the Derivation of cell-isolated influenza vaccine ...

EMEA: Questions/answers on Quality of IMPs - Inspections/QWP

16.02.2009
EMEA:
Questions/answers on Quality of IMPs - Inspections/QWP.
Reference to relevant paragraphs of the Guideline on the Requirements to the Chemical and Pharmaceutical Quality ...

EMEA: Question/answer on Plastic Immediate Packaging Material - Inspections/QWP

16.02.2009
EMEA:
Question/answer on Plastic Immediate Packaging Material - Inspections/QWP
No specific requirements or recommendations are provided in the EU Guideline on plastic immediate ...

EMEA: Guidance for companies requesting scientific advice or protocol assistance

16.02.2009
EMEA:
Guidance for companies requesting scientific advice or protocol assistance
This guidance document addresses a number of questions that users of the Scientific Advice or ...

European Commision: Recommendation on “Pharmacovigilance Urgent Measures” procedure under Article 107 of Directive 2001/83/EC

16.02.2009
European Commision:
Recommendation on “Pharmacovigilance Urgent Measures”
procedure under Article 107 of Directive 2001/83/EC. Where, as a result of the evaluation of ...

FDA: Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the International Conference on Harmonisation Regions

16.02.2009
FDA:
Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the International Conference on Harmonisation Regions
...

FDA: Nonclinical Evaluation for Anticancer Pharmaceuticals

16.02.2009
FDA:
Nonclinical Evaluation for Anticancer Pharmaceuticals
This guideline provides information for pharmaceuticals that are only intended to treat cancer in 69 patients with late ...