News
EMA: Concept paper on extrapolation of efficacy and safety in medicine development
25.04.2013
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
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EMA: Concept paper on assessing the toxicological risk to humans and the environment of veterinary pharmaceuticals in groundwater
25.04.2013
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
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EMA: Draft guideline on the compliance of authorised equine influenza vaccines with OIE requirements
25.04.2013
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
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GMP: EudraGMP Database now also comprises GDP Information
25.04.2013
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
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EMA: Guideline on good pharmacovigilance practices (GVP): Product-or population-specific considerations I: Vaccines for prophylaxis against infectious diseases - Draft
18.04.2013
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
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EMA: Guideline on good pharmacovigilance practices (GVP): P I - Vaccines for prophylaxis against infectious diseases – Definitions for inclusion in GVP annex I - Draft
18.04.2013
This is a draft guideline on good pharmacovigilance practices concering definitions for vaccines for prophylaxis against infectious diseases. ...
EMA: Guideline on good pharmacovigilance practices: Module II – Pharmacovigilance system master file
18.04.2013
The pharmacovigilance system master file definition is provided in Article 1(28e) of Directive 2001/83/EC and the minimum requirements for its content and maintenance are set out in the Commission
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EMA: Concept paper on the need for a reflection paper on quality aspects of medicines for older people
11.04.2013
Unlike the paediatric case (regulation (EC) No 1901/2006), there is no specific legal requirement for the development of medicines for geriatric use. Nevertheless, there is a need to ensure that
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GMP: FDA publishes Draft on Medical Devices Recalls Guideline
11.04.2013
The FDA has published an independent industry guideline on product recalls, biological and medical devices (\"Product Recalls, Including Removals and Corrections\"). According to this guideline,
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MHRA: Public consultation on Medical Devices (Amendment) Regulations 2013
11.04.2013
The MHRA is seeking views on its approach to implementing into UK law the Commission Regulations 722/2012 on animal tissues and Commission Regulation 207/2012 on e-labelling. ...