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News & Press: Regulatory Updates

PHSS Regulatory Update April 2013

29 November 2013  
Posted by: Tamsin Marshall
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PHSS Regulatory Update April 2013

INTRODUCTION

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

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

Europe

· EudraGMP database now contains information on good distribution practice (GDP)

· Implementation of the new rules on importation of active substances

· Revised Q&A on rules for importation of API V4.1

· CEPs for Herbal drug preparations

· Definition section of Ph. Eur. monographs and CEPs

· MHRA New 5 year corporate plan

USA

· Final Guidance for Industry -Non-Penicillin Beta-Lactam Drugs

· Glass Syringes for Delivering Drug and Biological Products: Technical Recommendations

· Draft Guidance for Industry SUPAC: Manufacturing Equipment Addendum

· Proposed Information Collection Activities: cGMP for Positron Emission Tomography Drugs

· FR Notice - Safety Considerations for Container Labels and Carton Labeling Design to Minimize Medication Errors.


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