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EMA: Concept paper on the need for a guideline on process validation of medicinal products containing biotechnology-derived proteins as active substance

06.06.2011
This concept paper addresses the need to develop guidance on process validation of biotechnology derived active substances. ...

MHRA: More exact paracetamol dosing for children to be introduced

06.06.2011
Updated dosing for children’s liquid medicines containing paracetamol has been developed to ensure children get the most effective amount, and to support giving it to them in the best way. The ...

EMA: Concept paper on the revision of the guideline on the use of the Common Technical Document format in the preparation of a registration application for traditional herbal medicinal product

01.06.2011
This concept paper is concerned with the revision of the guideline on the use of the Common Technical Document (CTD) format in the preparation of a registration application for traditional herbal ...

EMA: European Medicines Agency and Heads of Medicines Agencies propose measures to make information in application dossiers more transparent

01.06.2011
The European Medicines Agency and the Heads of Medicines Agencies (HMA) have released a guidance document on the identification of commercially confidential information and protection of personal ...

EMA: Standard operating procedure for internal audit conducted by the internal audit service

19.05.2011
This SOP describes the procedure for internal audits: including planning, conduct, communication, contradictory procedure, quality assessment, final report, action plan and any follow-up actions ...

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 ...