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EMA: Guideline on demonstration of target animal safety and efficacy of veterinary medicinal products intended for use in farmed finfish

17.05.2011
Veterinary medicinal products intended for use in finfish will have to satisfy all the usual requirements for approval. This includes documentation of quality, demonstration of safety for the ...

EMA: Reflection paper on risk mitigation measures related to the environmental risk assessment of veterinary medicinal

17.05.2011
This reflection paper provides a critical review of the adequacy/appropriateness of risk mitigation measures included in current marketing authorisations of veterinary medicinal products. These ...

EMA: Guideline on the clinical development of medicinal products for the treatment of cystic fibrosis

12.05.2011
The aim of this guideline is to provide guidance on the clinical development of compounds for the treatment of cystic fibrosis, a systemic chronically debilitating disease, mainly paediatric up ...

MHRA: Prohibited or restricted herbal ingredients

03.05.2011
The table provides a consolidated and alphabetical list of herbal ingredients which are subject to various restrictions. Some herbal ingredients are subject to more than one set of restrictions. ...

EMA: European Medicines Agency addresses development of new antibacterials

26.04.2011
The workshop covered issues including how new medicines to treat infections with bacteria resistant to many other antibiotics should be evaluated and how studies should be designed. The workshop ...

HMA: Best Practice Guides for the Submission and Processing of Variations in the Mutual Recognition Procedure

21.04.2011
The Co-Ordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh) has produced a compilation of the following Best Practice Guides regarding the submission and ...

EMA: Guideline on the conduct of bioequivalence studies for veterinary medicinal products

20.04.2011
It is the objective of this guidance to specify requirements for the design, conduct, and evaluation of bioequivalence studies for pharmaceutical forms with systemic action. In addition, guidance ...

GMP: New Guidance on Investigational Medicinal Products (IMPs) and Non Investigational Medicinal products (NIMPs)

20.04.2011
This document intends to clarify and provide additional guidance on the definition of IMP and to provide specific guidance about the use of non-investigational medicinal products (NIMPs), in ...

GMP: New answers published about Variations: EMA\'s updated

13.04.2011
The European Medicines Agency (EMA) offers a Q&A page which contains a collection of questions and answers on all regulatory activities linked to the issue of drug marketing authorisations. This ...

EMA: Procedural advice on fee reductions for designated orphan medicinal products

12.04.2011
Orphan medicinal products designated in accordance with Regulation (EC) No 141/2000 of 22 January 2000, are eligible for reductions on all fees payable under Union rules pursuant to Regulation ...