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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 ...

RAPS: WHO Seeks API Manufacturers for Prequalification Program

25.10.2016
The World Health Organization (WHO) has released an invitation to active pharmaceutical ingredient (API) manufacturers as part of an effort to increase access to and the affordability of care and ...

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. ...

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 ...

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: Regulatory information – Updated SME user guide now available

20.10.2016
The European Medicines Agency (EMA) has updated its user guide for micro, small and medium-sized enterprises (SMEs) operating in the pharmaceutical sector. The guide aims to support SMEs to better ...

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 ...

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 ...

FDA: ANDA Submissions – Prior Approval Supplements Under GDUFA

20.10.2016
This guidance is intended to assist applicants preparing to submit to FDA prior approval supplements (PASs) and amendments to PASs for abbreviated new drug applications (ANDAs) under section ...

GMP: What are the GMP Responsibilities of the Marketing Authorisation Holders?

20.10.2016
The GMP/GDP Inspectors Working Group of the European Medicines Agency (EMA) has published a concept paper to summarise the GMP responsibilities of the Marketing Authorisation Holders (MAH). It is ...