Best Practice Guide for the Decentralised and Mutual Recognition Procedures

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 ...

CMD(h) Standard Operating Procedure Disagreement in procedures – Referral to CMD(h)

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.

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’ ...

EMEA: New European Medicines Agency standard operating procedure. Performing duplicate detection

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 ...

EMEA: Guideline on the requirements for quality documentation concerning biological investigational medicinal products in clinical trials

This guideline outlines the requirements for data to be presented on the biological, chemical and pharmaceutical quality of Investigational Medicinal Products (IMP) containing ...

EMEA: Guideline on the development of medicinal products for the treatment of alcohol dependence

The aim of this guideline is to provide guidance for clinical studies for drugs developed for the treatment of alcohol dependence ...

EMEA: Appendix 2 to the guideline on the evaluation of anticancer medicinal products in man (CPMP/EWP/205/95 REV. 3) on Haematological malignancies

The aim of this appendix is to provide guidance on the design of confirmatory in patients with haematological malignancies. ...

EMEA: Draft guideline on Real time Release Testing (formerly Parametric Release) for external consultation

This guideline addresses the requirements for application of RTR testing to different kinds of products e.g. chemical and biological products and its scope is to facilitate the introduction of RTR ...

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