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GMP: WHO publishes revised Draft Guideline on Quality Risk Management

18.10.2012
In our GMP News from 23 September 2010, we referred to a draft guideline of the WHO on quality risk management (QRM). Now, this draft has been revised and published for comment. The new document ...

GMP: Additional Guidance Document on Active Substance Master File (ASMF) published by EMA

18.10.2012
The European Medicines Agency (EMA) has published an additional Guidance document relating to Active substance Master Files (formerly known as European Drug Master File). The new document will ...

GMP: FDA requires Registration of Manufacturing Facilities until December 2, 2012

18.10.2012
In a Federal Register Notice dated October 2, 2012 the FDA is notifying companies who manufacture Generic Drug Products and Active Pharmaceutical Ingredients as well as certain other sites and ...

EMA: Concept paper on the need for revision of the guideline on clinical investigation of medicinal products for the treatment of juvenile idiopathic arthritis

11.10.2012
The current CHMP Guideline on clinical investigation of medicinal products for the treatment of juvenile idiopathic arthritis (JIA) was adopted by CHMP in 2006. Since then there have been major ...

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 ...

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