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RAPS: FDA Adds 34 New and 33 Revised Bioequivalence Study Recommendations for Generic Drug Developers

25.10.2016
The US Food and Drug Administration (FDA) on Tuesday published 67 generic drug-specific recommendations (34 new and 33 revised) describing the agency’s expectations for developing ...

RAPS: EU, Japan to Share More Information on GMP Inspections

25.10.2016
The European Directorate for the Quality of Medicines and Healthcare (EDQM) this week announced a new agreement with Japanese authorities to share more information on the outcome of good ...

EMA: Opening up clinical data on new medicines

25.10.2016
EMA provides public access to clinical reports As of today, the European Medicines Agency (EMA) gives open access to clinical reports for new medicines for human use authorised in the European ...

GMP: MHRA publishes Draft Guidance on "Usability" of Medical Devices

25.10.2016
With its new draft guidance on human factors and usability requirements, the MHRA is giving greater emphasis to design process in the development of medical devices and combination products - ...

GMP: WHO publishes Second Draft of a Global Medical Devices Regulation

25.10.2016
With a draft document made up of 66 pages, the WHO intends to provide support regarding the introduction and implementation of regulations with regard to medical devices, including in vitro ...

RAPS: FDA Warns Four Foreign Drug Manufacturers

25.10.2016
The US Food and Drug Administration (FDA) on Tuesday released four warning letters sent in September to drug manufacturers from China, the UK, the Netherlands and Switzerland. ...

GMP: GDUFA: FDA's new Guidance on Self-Identification of Generic Drug Manufacturers

25.10.2016
The GDUFA (Generic Drug User Fee Amendments) is a legislative package which came into force in 2012 and entitles the US-American FDA to collect fees from generic drug manufacturers, who ...

FDA: Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients

20.10.2016
This document is intended to provide guidance regarding good manufacturing practice (GMP) for the manufacturing of active pharmaceutical ingredients (APIs) under an appropriate system for managing ...

EMA: First comprehensive overview of global initiatives on medicine regulation published

20.10.2016
The European Medicines Agency (EMA) has published today an overview of existing international regulatory initiatives for human medicines. The mapping was carried out by EMA on behalf of the ...

EMA: Concept paper on good manufacturing practice and marketing authorisation holders

20.10.2016
The current EU Guide to GMP refers in several places to Marketing Authorisation Holder (MAH) companies and their responsibilities in relation to GMP ensuring that the manufacturing authorisation ...