EMA: Draft guideline on the use of phthalates as excipients in human medicinal products

Literature data in animals show that certain phthalates are associated with effects on reproduction and development in relation to their hormonal (anti-androgenic) properties. Currently available ...

EMA: Guideline on the acceptability of names for veterinary medicinal products processed through the centralised procedure

A Community marketing authorisation is valid throughout the European Union and the invented name of the medicinal product is an integral part of the authorisation.The centralised procedure ...

GMP: EMA publishes Updated Procedural Advice for Centralised Marketing Authorisations

The European Medicinal Agency (EMA) has recently published a revised version of its documents on procedural advice for centralised marketing authorisations and for generic products. ...

GMP: New FDA Guidance for the Prevention of Cross Contamination of Beta-Lactam Antibiotics

This guidance describes the importance of implementing manufacturing controls to prevent cross-contamination of finished pharmaceuticals and active pharmaceutical ingredients (APIs) with ...

EMA: Concept paper on extrapolation of efficacy and safety in medicine development

The concept paper is intended to discuss the need and possibility to develop a framework for extrapolation approaches that are considered scientifically valid and reliable to support medicine ...

EMA: Concept paper on assessing the toxicological risk to humans and the environment of veterinary pharmaceuticals in groundwater

This intended guideline should provide further technical support to the implementation of the VICH 19 guidelines GL6 and GL38 on the environmental risk assessment (ERA) of veterinary medicinal ...

EMA: Draft guideline on the compliance of authorised equine influenza vaccines with OIE requirements

This document provides guidance on the data requirements to support modifications to authorised, equine influenza vaccines based on recommendations from the OIE Expert Surveillance Panel on Equine ...

GMP: EudraGMP Database now also comprises GDP Information

The new database, now called EudraGMDP, is a key deliverable of the new European Falsified Medicines Directive, which came into force in January 2013. It will make the supervision of manufacturing ...

EMA: Guideline on good pharmacovigilance practices (GVP): Product-or population-specific considerations I: Vaccines for prophylaxis against infectious diseases - Draft

The objective of this module is to strengthen the conduct of pharmacovigilance for vaccines. It should be noted that the overall objectives and processes of pharmacovigilance are no different for ...

EMA: Guideline on good pharmacovigilance practices (GVP): P I - Vaccines for prophylaxis against infectious diseases – Definitions for inclusion in GVP annex I - Draft

This is a draft guideline on good pharmacovigilance practices concering definitions for vaccines for prophylaxis against infectious diseases. ...

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