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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). ...

EMA: Concept paper on the need for revision of note for guidance on clinical investigation of medicinal products for the treatment of cardiac failure - Draft

07.03.2013
Chronic Heart Failure (CHF) encompasses heterogeneous groups of patients with a wide spectrum of symptoms and different causes. The CHMP Guideline on the clinical investigations of medicinal ...

EMA: Guideline on the use of porcine trypsin used in the manufacture of human biological medicinal products - Draft

07.03.2013
This guideline describes the information to be considered by the manufacturer of human biological medicinal products using porcine trypsin. ...

GMP: European Medicines Agency recommends approval of first vaccine for meningitis B

07.03.2013
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended the granting of a marketing authorisation for Bexsero, a new vaccine intended for the ...