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News & Press: Regulatory Updates

PHSS Regulatory Update January 2014

09 January 2014  
Posted by: Tamsin Marshall
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INTRODUCTION

During the last 4 weeks there have been a number of developments in the regulation of the pharmaceutical industry. This month most reported issues have come from the EU and USA regulatory authorities.

The topics covered in this edition of the "Update” include:

Europe

·         Statements of non-compliance with GMP now publicly available in EudraGMDP

·         Responses to consultation on Annex 16

·         Responses to the public consultation on draft guidelines on formalised risk assessment of appropriate GMP for excipients

·         Pharmeuropa

MHRA

·         Self inspection and data integrity

USA

·         FDA and EMA launch generic drug application inspections initiative

·         Naming of Drug Products Containing Salt Drug Substances

·         Recall of all non-expired sterile drugs from Abrams Royal Compounding Pharmacy – Dallas

·         Rx Formulation’s voluntary recall of sterile drug products

·         Draft Guidance for Industry on Size, Shape, and Other Physical Attributes of Generic Tablets and Capsules

·         Proposed increase in US FDA Inspections in China

·         FDA takes significant steps to address antimicrobial resistance

·         Draft Guidance - Pharmacy Compounding of Human Drug Products Under Section 2 503A of the Federal Food, Drug, and Cosmetic Act

·         Center for Drug Evaluation and Research (CDER) Strategic Plan 2013-2017

International

The International Conference on Harmonisation (ICH)

·         Future ICH Topics and Organisation Towards Increased Engagement Globally

Products

·         Fluoroscein strips

Documents

·         New Orange Guide & green guide

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