News
FDA: Rare Pediatric Disease Priority Review Vouchers, Draft Guidance for Industry
20.11.2014
This guidance provides information on the implementation of section 908 of the Food and Drug Administration Safety and Innovation Act (FDASIA), which added section 529 to the Federal Food, Drug,
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EMA: Draft qualification opinion on in vitro hollow-fibre-system model of tuberculosis (HFS-TB)
20.11.2014
Approximately 10 years ago, the HFS-TB was developed by Gumbo et al. and first presented at the Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC). Since that time, the model
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EMA: Questions and answers: Positions on specific questions addressed to the Pharmacokinetics Working Party,
20.11.2014
In the context of assessment procedures, the Pharmacokinetics Working Party (PKWP), or its predecessor the Therapeutic Subgroup on Pharmacokinetics of the Efficacy Working Party (EWP-PK subgroup),
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GMP: ECA and PQG publish next chapter of the interpretation of the EU GDP Guide
13.11.2014
The ECA Foundation Working Group on GDP and the Pharmaceutical Quality Group (PQG) have published an additional chapter of the interpretation of the EU Good Distribution Practice (GDP Guide). ...
EMA: List of centrally authorised products requiring a notification of a change for update of annexes
13.11.2014
Parallel distributors are only required to inform the EMA of changes to the labelling or leaflet related to any update of the annexes of marketing authorisation once a year in their annual update
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EMA: Procedural advice on CHMP/CAT/PRAC Rapporteur/Co-Rapporteur appointment principles, objective criteria and methodology in accordance with Article 62 (1) of Regulation (EC) No 726/2004
13.11.2014
This paper sets the principles, objective criteria and the methodology on the rapporteur/co-rapporteur appointment procedure. These principles and objective criteria shall apply to several
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GMP: Frequently asked Questions about Good Distribution Practice Implementation (EU)
13.11.2014
The implementation of the new EU Good Distribution Practice Guideline is a challenging task for pharmaceutical companies, wholesalers, storage facilities and transportation companies. However, a
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EMA: Guideline on similar biological medicinal products
06.11.2014
This guideline replaces the Guideline on similar biological medicinal products (CHMP/437/04). The document describes and addresses the application of the biosimilar approach, the choice of the
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EMA: European Medicines Agency procedural advice for users of the centralised procedure for similar biological medicinal product applications
06.11.2014
This document addresses a number of questions which users of the Centralised Procedure may have. It provides an overview of the EMA position on issues, which are typically addressed during the
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EMA: Draft guideline on influenza vaccines – submission and procedural requirements
06.11.2014
The need to update the current guidelines regarding the development of influenza vaccines was recognised in the wake of the 2009-2010 influenza pandemic, as the Agency conducted its “lessons
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