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GMP: Chinese API Manufacturers revealed to have used gutter oil for the Manufacture of Antibiotics

11.10.2012
A few manufacturers of the API 7-aminocephalosporanic acid have been recently accused of having used waste oil in the fermentative manufacturing process of this antibiotic. ...

EMA: Guideline on clinical investigation of medicinal products for the treatment of Multiple Sclerosis (Rev.2) - Draft

11.10.2012
This guideline replaces the guideline on clinical investigation of medicinal products for the treatment of multiple sclerosis (CPMP/EWP/561/98, Rev.1). ...

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 ...

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 ...

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 ...

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 ...

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, ...

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. ...