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EMA: Draft guideline on the pharmacokinetic and clinical evaluation of modified release dosage forms (EMA/CPMP/EWP/280/96 Corr1)

21.03.2013
This guideline replaces Guideline on Modified Release Oral and Transdermal Dosage Forms Section II 9 (Pharmacokinetic and Clinical Evaluation (EMA/CPMP/EWP/280/96 Corr*)). ...

EMA: European Medicines Agency updates product information template to label medicines subject to additional monitoring and encourage adverse-reaction reporting

21.03.2013
As part of the implementation of the European Union (EU) pharmacovigilance legislation, the European Medicines Agency has updated the product-information template to allow easy identification of ...

EMA: mplementation plan for the introduction of the new pharmacovigilance legislation requirements into the product information of centrally approved medicinal products.

21.03.2013
As part of the implementation of the European Union (EU) pharmacovigilance legislation, the European Medicines Agency has updated the product-information template to allow easy identification of ...

GMP: Final GDP Guideline published by EU Commission

21.03.2013
The new GDP Guideline will apply not only to the wholesalers and manufacturers of pharmaceuticals, it also incorporates the specific requirements for the Brokers dealing with pharmaceutical ...

EMA: Draft guideline on clinical investigation of medicinal products for the treatment of systemic lupus erythematosus, cutaneous lupus and lupus nephritis

14.03.2013
The purpose of this guideline is to provide guidance on development, manufacturing and control for Marketing Authorisation Applications for influenza vaccines. The Quality Module has been updated ...

EMA: Draft guideline on influenza vaccines – quality module

14.03.2013
The purpose of this guideline is to provide guidance on development, manufacturing and control for Marketing Authorisation Applications for influenza vaccines. The Quality Module has been updated ...

EU: Guidelines of 7 March 2013 on Good Distribution Practice of Medicinal Products for Human Use

14.03.2013
The wholesale distribution of medicinal products is an important activity in integrated supply chain management. Today’s distribution network for medicinal products is increasingly complex and ...

EMA: Reflection paper on the data requirements for intravenous liposomal products developed with reference to an innovator liposomal product

14.03.2013
There has been a significant interest to develop drug delivery methods for potent albeit sometimes toxic, highly lipophilic/poorly water soluble, unstable compounds, or for tissue targeting of ...

EMA: Reflection paper on quality of essential oils as active substances in herbal medicinal products/traditional herbal medicinal products - Draft

07.03.2013
This reflection paper applies to essential oils used as active substances in herbal medicinal products (HMPs) both for human and veterinary use and in traditional herbal medicinal products (THMPs) ...

EMA: Concept paper on the need to revise the guideline on the clinical development of fixed dose combinations of medicinal products regarding dossier content requirements - Draft

07.03.2013
The current guideline CHMP/EWP/240/95 Rev. 1 contains a section describing the legal basis applicable to fixed dose combination (FDC) product marketing authorisation application (MAA). ...