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FDA: Guidance for Industry Organ-Specific Warnings: Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Human Use — Small Entity Compliance Guide

19.08.2010
This guidance is intended to help small businesses understand and comply with FDA’s organ-specific labeling regulation for over-the-counter (OTC) internal analgesic, antipyretic, and ...

EMA: Reflection paper on expectations for electronic source data and data transcribed to electronic data collection tools in clinical trials

13.08.2010
The scope of this reflection paper is electronic systems, (including instruments, software and services) used in clinical trials in the creation/capture of electronic clinical data, such ...

EMA: Terms of reference and procedures for participating authorities (manufacturers of medicinal products)

13.08.2010
The overall objective is to see whether greater international collaboration can help to better distribute inspection capacity, allowing more sites to be monitored and reducing unnecessary ...

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

13.08.2010
In July/August 2010, CMDh (Co-ordination Group for Mutual Recognition and Decentralised Procedures) published paediatric assessment reports following completion of eight Article 45 work-sharing ...

EMA: Scientific guideline: Guideline on quality, non-clinical and clinical aspects of live recombinant viral vectored vaccines

11.08.2010
The objective of this guideline is to provide recommendations on the quality, non-clinical and clinical studies that should be performed in order to obtain marketing authorisation of a live ...

EMA: Scientific guideline:\'Guideline on the clinical investigation of medicinal products for the treatment of attention deficit hyperactivity disorder (ADHD)\' (EMEA/CHMP/EWP/431734/2008)

11.08.2010
Overview of comments received on \'Guideline on the clinical investigation of medicinal products for the treatment of attention deficit hyperactivity disorder ...

EMA: Guideline on the clinical investigation of medicinal products for the treatment of attention deficit hyperactivity disorder (ADHD)

11.08.2010
This Guideline is intended to provide guidance on the evaluation of new medicinal products in ADHD with focus on the childhood onset. It is the first guideline written in psychiatry to address a ...

CMDh: CMDh Recommendation for classification of unforeseen variations according to Article 5 of Commission Regulation (EC) 1234/2008

11.08.2010
CMDh Recommendation for classification of unforeseen variations according to Article 5 of Commission Regulation (EC) 1234/2008 ...

CMDh: CMDh BEST PRACTICE GUIDES FOR THE SUBMISSION AND PROCESSING OF VARIATIONS IN THE MUTUAL RECOGNITION PROCEDURE

11.08.2010
Commission Regulation (EC) No. 1234/2008 is effective 1 January 2010 and replaces 1084/2003/EC. It concerns variations in the Mutual Recognition procedure and Centralised procedure. Since the ...

Polish Office for Registration: The statement of the President of the Office for Registration relating to bioequivalence of the generic medicinal products

04.08.2010
The statement of the President of the Office for Registration relating to bioequivalence of the generics with reference to original medicinal products. ...

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