News
EMA: Guideline on the Evaluation of Medicinal Products indicated for treatment of bacterial infections
08.04.2010
This guideline considers the microbiological and clinical data required to support indications, dose regimens and durations of therapy for antibacterial agents and the layout and wording of some
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EMA: Draft guideline on the clinical investigation of human normal immunoglobulin for intravenous administration (IVIg)
08.04.2010
The purpose of this guideline is to provide applicants and regulators with harmonized guidance for applications for marketing authorization for IVIg. ...
EMA: Updated inventory of herbal substances for assessment
08.04.2010
Inventory of herbal substances for assessment – alphabetical order. ...
EMA: Compilation of Community Procedures on Inspections and Exchange of Information
08.04.2010
The Compilation of Procedures is a collection of GMP inspection- related procedures and forms agreed by the GMP inspectorates of all the Member States and designed to facilitate administrative
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Best Practice Guide for the Decentralised and Mutual Recognition Procedures
08.04.2010
Competent authorities should ensure that their assessment reports are written according to the CMD guideline on the assessment report for Mutual Recognition and Decentralised Procedure and the
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CMD(h) Standard Operating Procedure Disagreement in procedures – Referral to CMD(h)
18.03.2010
Procedure to be followed to the discussion in CMD(h) in case of disagreement between member states in particular mutual recognition or decentralised procedure. ...
EMEA: Experience of the CHMP Peer Review – A tool for quality assurance of the evaluation of new marketing authorization application in the Centralised Procedure.
18.03.2010
The CHMP Peer Review process applies to the initial phase of the assessment of new Marketing Authorisation Application. It is a process by which other members of the CHMP review Rapporteurs’
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EMEA: New European Medicines Agency standard operating procedure. Performing duplicate detection
18.03.2010
The purpose of duplicate detection is to eliminate duplicate ICSRs from the EudraVigilance system, to ensure that the calculations and analyses performed on data in the EudraVigilance system will
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EMEA: Guideline on the requirements for quality documentation concerning biological investigational medicinal products in clinical trials
18.03.2010
This guideline outlines the requirements for data to be presented on the biological, chemical and pharmaceutical quality of Investigational Medicinal Products (IMP) containing
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