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GMP: Data Integrity - MHRA\'s Current Expectations

20.02.2014
In January 2014, the MHRA declared that as of 2014, pharmaceutical facilities will be expected to verify data integrity in the context of self inspections. ...

FDA: Guidance for Industry Analytical Procedures and Methods Validation for Drugs and Biologics - Draft guidance

20.02.2014
This revised draft guidance complements the International Conference on Harmonisation (ICH) guidance Q2(R1) Validation of Analytical Procedures: Text and Methodology (Q2(R1)) for developing and ...

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FDA: Draft guidance: Analgesic Indications: Developing Drug and Biological Products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