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EMA: Scientific guideline: Reflection paper on stem cell-based medicinal products

07.02.2011
The aim of this reflection paper is to cover specific aspects related to stem cell-based medicinal products for Marketing Authorisation Application. This reflection paper should be read in ...

EMA: Regulatory and procedural guideline: European Medicines Agency procedural advice for users of the centralised procedure for generic/hybrid applications

07.02.2011
This document addresses a number of questions which users of the Centralised Procedure may have. It provides an overview of the EMA position on issues, which are typically addressed during the ...

EMA: Report on the survey of all paediatric uses of medicinal products in Europe

21.01.2011
Regulation (EC) No 1901/2006 of the European Parliament and of the Council on medicinal products for paediatric use (hereafter referred as the “Paediatric Regulation”) aims to facilitate the ...

EMA: Reflection paper on the necessity of initiatives to stimulate the conduct of clinical studies with herbal medicinal products in the paediatric population

21.01.2011
It is well documented that herbal medicinal products (HMPs) are widely used in the general population and specifically in children even if there are important differences among European countries ...

FDA: Size of Beads in Drug Products Labeled for Sprinkle

21.01.2011
This draft guidance provides sponsors of new drug applications (NDAs), abbreviated new drug applications (ANDAs), and biologics licensing applications (BLAs) the Center for Drug Evaluation and ...

EMA: Scientific guideline: Draft template for the Qualified Person’s declaration concerning GMP compliance of the active substance used as starting material and verification of its supply chain “The QP declaration template”, draft

14.01.2011
The objective of this Qualified Person (QP) Declaration Template is to emphasise the importance of providing a comprehensive declaration, to harmonise the format for the declaration, to forestall ...

EMA: Dossier requirements of the members of the Committee for Medicinal Products for Human Use (CHMP)

14.01.2011
Dossier requirements of the members of the Committee for Medicinal Products for Human Use (CHMP) - number of CD and paper copies ...

EMA: Scientific guideline: Reflection paper on the need for active control in therapeutic areas where use of placebo is deemed ethical and one or more established medicines are available, draft:

14.01.2011
This paper describes regulatory considerations, and expectations of applicants, in discussing the importance of a direct comparison to active control for a properly informed decision on ...

MHRA: Medicines for children: Publication of assessment reports for European Article 45 and 46 paediatric work-sharing procedures

14.01.2011
In November 2010, the CMDh (Co-ordination Group for Mutual Recognition and Decentralised Procedures) published three more paediatric assessment reports following completion of Article 45 ...

FDA: Electronic Source Documentation in Clinical Investigations

14.01.2011
This document provides guidance to sponsors, contract research organizations (CROs), data management centers, and clinical investigators on capturing, using, and archiving electronic data in ...