European Commission: Notice to Applicants, Volume 2C Guidance on Summary of Product Characteristics (SmPC)

Notice to Applicants, Volume 2C, the guidance document on Summary of Product Characteristics (SmPC) has been updated. It will apply as from 1 May 2010 but submissions in accordance with the ...

EMEA: ICH Topiq Q8 (R2) Pharmaceutical Development - Note for guidance on pharmaceutical development

This guideline is intended to provide guidance on the contents of Section 3.2.P.2 (Pharmaceutical Development) for drug products as defined in the scope of Module 3 of the Common Technical ...

Polish Ministry of Health: Regulation project relating to Braille

Regulation project relating to put the Braille on the packaging of the specific types of the medicinal products. ...

FDA: Microbiological Data for Systemic Antibacterial Drug Products — Development, Analysis, and Presentation

The purpose of this guidance is to inform industry of the Food and Drug Administration’s (FDA’s) current thinking regarding the types of microbiological studies, assessments, and clinical ...

European Commission: Notice to Applicants, Volume 2B - Electronic Common Technical Document (eCTD)

This concerns an update in EudraLex. The old XML files (dated March 2007) of the electronic application form in EudraLex (form-new, form-variation, form-renewal) should be replaced by the new XML ...

European Commission: Notice to Applicants – Veterinary Medicinal Products - Volume 6B

Presentation and content of the dossier – Part 1: Summary of the dossier Part 1A Electronic Application form (XML file) In addition to the word version DG Enterprise and Industry releases the ...

European Commission: Notice to Applicants – Veterinary Medicinal Products - Volume 6C

Electronic application form (XML file) for the renewal of a centrally marketing authorisation Electronic Application form (XML file) for the variation of a centrally marketing authorisation In ...

EMEA: Guideline on non-clicical and clinical development of Similar medicinal products containing recombinant Erythropoietins

The non-clinical section addresses the pharmaco-toxicological assessment and the clinical section the requirements for pharmacokinetic, pharmacodynamic, efficacy and safety studies as well as the ...

EMEA: Revised Priority list for studies into off-patent paediatric medicinal products

The aim of Regulation (EC) No1901/2006 of the European Parliament and the Council on Medicinal Products for Paediatric Use, as amended, is to increase availability of medicines authorised for ...

EMEA: Revised Qualification of novel methodologies for drug development: Guidance to applicants

The qualification process addresses innovative drug development methods and tools. It will focus on the use of novel methodologies developed by consortia, networks, public/private partnerships, ...

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