Aktualności
EMA: Guideline on clinical investigation of medicinal products, including depot preparations in the treatment of schizophrenia
11.10.2012
This guideline replaces NfG on clinical investigation of medicinal products in the treatment of schizophrenia (CPMP/EWP/559/95). ...
EMA: Concept paper on the need for revision of the guideline of medical products used in weight control
04.10.2012
The current guideline on medicinal products used in weight control (CPMP/EWP/281/96 Rev.1) was adopted by the CHMP 15 November 2007. Since then the marketing authorisations of 2 weight-control
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EMA: Draft guideline on the use of bovine serum in the manufacture of human biological medicinal products
04.10.2012
This guideline replaces Note for Guidance on the use of bovine serum in the manufacture of human biological medicinal products (CPMP/BWP/1793/02). ...
EMA: Additional guidance on documents relating to an active substance master file
04.10.2012
Additional guidance on completing the Annex 2-letter of access, Annex 3-submission letter and administrative details for documents relating to an active substance master file and Annex
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EMA: Paediatric addendum to CHMP guideline on clinical investigation of medicinal products in the treatment of lipid disorders
04.10.2012
This is an addendum to the Guideline on Clinical Investigation of Medicinal Products in the Treatment of Lipid Disorders (EMA/CPMP/3020/2003). It is not meant as a guidance document on its own but
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GMP: The new EU GMP Chapter 1 in Pharmaceutical Development
27.09.2012
The Directorate-General for Health and Consumers (DG SANCO) of the European Commission has published the final version of the revised Chapter 1 of the EU-GMP Guide, which will now be called
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GMP: The new EU GDP Guideline - What will happen next?
27.09.2012
In order to change the \"old\" Good Distribution Practices Guideline from 1994 the European Commission published a proposal for a new version. A large number of individuals, associations,
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MHRA: Paracetamol overdose: new guidance on treatment with intravenous acetylcysteine
27.09.2012
New simplified guidance on treating paracetamol overdose with intravenous acetylcysteine is now in place. This includes an updated treatment nomogram. ...
EMA: Guideline on quality of transdermal patches - Draft
20.09.2012
This guideline together with the new Guideline on Quality of Oral Modified Release Products replaces the Note for Guidance on Modified Release products: A: Oral dosage Forms B: Transdermal Dosage
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EMA: Guideline on quality of oral modified release products - Draft
20.09.2012
This guideline together with the Guideline on Quality of Transdermal Patches replaces Note for Guidance on Modified Release products: A: Oral dosage Forms B: Transdermal Dosage Forms. Part I
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