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News & Press: Regulatory Updates

PHSS Regulatory Update October 2012

29 November 2013  
Posted by: Tamsin Marshall
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PHSS Regulatory Update October 2012

INTRODUCTION

During the last 4 weeks there have been a number of developments in the regulation of the pharmaceutical industry. This month reported issues have come from the EU,USA, Canadian, Indian, PIC/S regulatory authorities plus Interpol

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

Europe

· Draft Guideline on the use of bovine serum in the manufacture of human biological medicinal products

· Guideline on quality of oral modified release products

· Public consultation (MLX 379): Transposition of Directive 2011/62/EU ("the Falsified Medicines Directive”) into UK legislation

· MHRA wins High Court case on wholesaler dealing

USA

· Guidance for Industry -Self-Identification of Generic Drug Facilities, Sites, and Organizations

· Blood products - Exceptions and Alternative Procedures Approved Under 21 CFR 640.120

· Impact of Severe Weather Conditions on Biological Products (update)

International

Canada

· Consultation Draft Guidance on GMP for APIs (GUI-0104)

WHO

· Revised Draft Guideline on Quality Risk Management

India

· Draft Guideline on Good Distribution Practices for Biological Products

INTERPOL-

· PANGEA V Coordinated operation against illegal internet sale of medicines

PIC/s

· PIC/S Meetings Kiev, Ukraine

Products

· Contaminated steroid injections – USA Multistate Fungal Meningitis Outbreak

Other

· Ben Venue Laboratories, Inc. Resumes Limited Drug Manufacturing


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