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EMA: Guidance on centrally authorised products requiring a notification of a change for update of annexes

25.10.2012
On 23 July 2010 and after a consultation phase, the EMA communicated to all Parallel Distributors that it is not required to inform the EMA on changes to the labelling or leaflet related to any ...

EMA: European Medicines Agency pre-submission procedural advice for users of the centralised procedure

25.10.2012
This guidance document addresses a number of questions which users of the centralised procedure may have. It provides an overview of the European Medicines Agency’s position on issues, which are ...

EMA: Draft guideline on clinical investigation of medicinal products for the treatment of acute heart failure

18.10.2012
The CHMP Note for Guidance on the Clinical Investigation of Medicinal Products for the Treatment of Cardiac Failure (CHMP/EWP/235/95, rev. 1) provides limited regulatory guidance for development ...

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). ...

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