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EMA: New Guideline on Development of Medicines for Paediatric Use.

18.08.2011
The European Medicines Agency has recently published a draft guideline on pharmaceutical development of medicines for paediatric use. In January 2007 Regulation EC No 1901/2006 (the \"Paediatric ...

EMA: Reflection paper on the Use of Interactive Response Technologies (Interactive Voice/Web Response Systems) in Clinical Trials.

12.08.2011
As IVR/IWR systems are developed to facilitate overall drug management and expanded to assist with dose titration, unblinding and expiry date update, the intent of the paper is to provide guidance ...

FDA: E16 Biomarkers Related to Drug or Biotechnology Product Development: Context, Structure, and Format of Qualification Submissions.

12.08.2011
The guidance describes recommendations regarding context, structure and format of regulatory submissions for qualification of genomic biomarkers (as defined in ICH E15). Qualification is a ...

HMA: Requirements on Electronic Submissions (NeeS and eCTD) and Paper Documentation for New Applications within MRP, DCP or National Procedures.

12.08.2011
This document describes the documentation requested by each National Competent Authority for new applications for approval for Marketing Authorisation. ...

HMA: Contact Points for Advice on Mutual Recognition and Decentralised Procedures.

12.08.2011
The list is provided to assist pharmaceutical companies identifying a contact point for advice on the Mutual Recognition or Decentralised Procedures in each Member State. The persons listed should ...

HMA: Procedural Advice on Repeat-Use.

12.08.2011
This document describes the procedure to be adopted for “Repeat Use”. ...

HMA: Recommendation for Marketing Authorisation Holders on the Pharmacovigilance System and Risk Management Plan in the Mutual Recognition and Decentralised Procedures.

12.08.2011
This CMDh guidance document aims to provide specific guidance for RMS and CMS on the submission of data related to Pharmacovigilance systems, the necessity for submission of Risk Management Plans ...

GMP: Revised EU Guideline on Good Distribution Practice with major Changes

12.08.2011
The guideline was revised to take into account advancements of practices for an appropriate storage and distribution of medicinal products in the European Union. Moreover, it should take into ...

EMA: Risk Based Quality Management in Clinical Trials.

09.08.2011
The purpose of this reflection paper is to facilitate the development of a more systematic, prioritised, risk-based approach to quality management of clinical trials, to support the principles of ...

GMP: FDA proposes Changes in Sterility Testing of Biological Products.

09.08.2011
The proposed rule is intended to provide manufacturers of biological products with greater flexibility and to encourage the use of the most appropriate and state-of-the-art test methods for ...