News
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
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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
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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
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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
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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
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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
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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
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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
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EMA: Concept paper for the revision of the guideline on data requirements for multi-strain dossiers for inactivated vaccines against avian influenza, blue tongue and foot and mouth disease
29.09.2016
The Immunologicals Working Party recommends to review, and possibly revise, the Committee for Medicinal Products for Veterinary Use ‘Guideline on data requirements for multi-strain dossiers for
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