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News & Press: Regulatory Updates

PHSS Regulatory Update May 2014

03 June 2014  
Posted by: Tamsin Marshall
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PHSS Regulatory Update May 2014

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

·         Good distribution practice for medicinal products for human use Q&A

·         EU GMP Chapter 6: Quality Control

·         New database to assist authorities in the fight against counterfeit/falsified medical products

·         148th Session Of The European Pharmacopoeia Commission

·         Early Access to Medicines Scheme

·         Scientific review of the National Institute for Biological Standards

·         MHRA Business Plan for 2014-15

·         GMDP stakeholder inspection feedback questionnaire

·         End of herbal sell through period

USA

·         Medical Device Tracking - Guidance for Industry and FDA Staff

·         Guidance for Industry -Interpreting Sameness of Monoclonal Antibody Products Under the Orphan Drug Regulations

·         Increasing public access to FDAs compliance and enforcement data

·         Inter-governmental Working Meeting on Pharmacy Compounding

·         USP Spectrographic methods – revision

·         Endotoxin Testing Recommendations for Single-Use Intraocular Ophthalmic Devices

International

·         Thai FDA to apply for PIC/S membership

Documents

·         Guidance on the interpretation and implementation of European GDP-Ch.7 – Outsourcing

Products

·         Alli (60 mg orlistat capsules) GSK: Recall - Product Tampering

·      Rare but serious neurologic problems after epidural corticosteroid injections


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