EN PL

News

EMA: User guide for micro, small and medium-sized enterprises

07.08.2014
This guide has been prepared for micro, small and medium-sized enterprises (SMEs) operating in the pharmaceutical sector. Its aim is to facilitate understanding of the main aspects of medicinal ...

GMP: European Pharmacopoeia Commission announces Strategy for Implementation of ICH Q3D

31.07.2014
In this release, the Commission explains their approach with regard to the integration of the content of ICH Q3D in the European Pharmacopoeia. ...

RAPS: FDA Issues Guidance on \'Substantial Equivalence\' Process Used to Bring Devices to Market

31.07.2014
The US Food and Drug Administration (FDA) has issued an extensive and long-awaited guidance document on its premarket notification program—also known as the 510(k) pathway—detailing how ...

EMA: Draft rules of procedures on the organisation and conduct of public hearings at the Pharmacovigilance Risk Assessment Committee (PRAC)

31.07.2014
The Pharmacovigilance Risk Assessment Committee (PRAC) has the possibility to hold public hearings in the context of safety referral procedures under Article 20 of Regulation (EC) 726/2004, and ...

FDA: Current Good Manufacturing Practice — Interim Guidance for Human Drug Compounding Outsourcing Facilities Under Section 503B of the FD&C Act

24.07.2014
This interim guidance describes FDA’s expectations regarding compliance with current good manufacturing practice (CGMP) requirements for facilities that compound human drugs and register with ...

EMA: Concept paper on use of aminoglycosides in animals in the European Union: Development of resistance and impact on human and animal health

24.07.2014
Aminoglycosides have a broad antibacterial spectrum with good activity against Gram negative species and less activity against Gram positive species. This class of antimicrobials has no effect ...

EMA: Concept paper on transferring quality control methods validated in collaborative trials to a product/laboratory specific context

24.07.2014
Demonstration of scientific validity is a necessary condition for regulatory acceptance of any test method, including 3R (replacement, reduction, refinement) testing approaches. ...

GMP: Final ICH M7 Guideline on Genotoxic Impurities published

24.07.2014
On on 15 July 2014, the ICH issued the guideline M7 \"Assessment and Control of DNA reactive (mutagenic) Impurities in Pharmaceuticals to limit Potential Carcinogenic Risk\" as Step 4 document. In ...

EMA: Guide on methodological standards in pharmacoepidemiology revised to include pharmacogenetic studies

17.07.2014
The European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP), coordinated by the European Medicines Agency, has revised its guide on methodological standards in ...

GMP: New GMP Non-Compliance Reports in EMA Database

17.07.2014
The European Medicines Agency (EMA) has established a database which contains GMP and GDP compliance information. This database is called EudraGMDP. ...