EN PL

News

EMA: New EMA Guidance Qualification of novel Methodologies for Drug Development

13.02.2014
The European Medicines Agency EMA has published the revised Guidance to Applicants \"Qualification of novel methodologies for drug development\". ...

EMA: Regulatory information - EMA clarifies interpretation of new variation classification categories

13.02.2014
The Commission guidelines on variations to marketing authorisations of medicinal products were amended in 2013. The revision of the variations guidelines was principally triggered by the ...

FDA: Draft guidance: Analgesic Indications: Developing Drug and Biological Products

13.02.2014
This guidance focuses on clinical drug development and trial design issues and chemistry, manufacturing, and controls (CMC) concerns that are unique to the study of acute, chronic, and ...

EMA: Draft guideline on key aspects for the use of pharmacogenomic methodologies in the pharmacovigilance evaluation of medicinal products

06.02.2014
This guideline addresses the influence of pharmacogenomics on pharmacovigilance activities, including considerations on how to evaluate the pharmacovigilance related issues for medicinal products ...

EMA: Draft guideline on the investigation of subgroups in confirmatory clinical trials

06.02.2014
Investigation into the effects of treatment in well-defined subsets of the trial population is an integral part of clinical trial planning, analysis and inference that follows the inspection of ...

EMA: EMA releases guidance on the use of pharmacogenomics to improve safety monitoring of medicines

06.02.2014
The European Medicines Agency has released a draft guideline for public consultation which addresses how pharmacogenomics can support pharmacovigilance activities and in particular how the results ...

EMA: Procedure for orphan-medicinal-product designation: Guidance for sponsors

06.02.2014
The EMA strongly encourages sponsors to request a pre-submission meeting prior to filing an application for orphan medicinal product designation. Pre-submission meetings for orphan designation are ...

EMA: Draft guideline on core SmPC and package leaflet for (99Mo/99mTc) generator

30.01.2014
This guideline describes the information to be included in the Summary of Products Characteristics (SmPC) and Package Leaflet for (99Mo/99mTc) generator. ...

EMA: Guideline for the conduct of efficacy studies for non-steroidal anti-inflammatory drugs

30.01.2014
The objective of this guideline is to specify recommendations for the design, conduct, and evaluation of studies for Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) to be provided in support of an ...

GMP: Update: Electronic Submission of Marketing Authorisation Dossiers

30.01.2014
The document describes the approach to the submission of a dossier in the electronical format in the context of the centralised procedure (since the 1st of January 2010, all paper submissions have ...