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News & Press: Regulatory Updates

PHSS Regulatory Update July 2013

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

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 and WHO regulatory authorities.

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

Europe

· Concept paper revision of the note for guidance on manufacture of the finished dosage form

· Importation of active substances (Heads of Medicines agencies)

· Guidance for electronic and paper submissions for Certificates of Suitability (CEPs)

· Guideline on requirements for revision/renewal of CEPs and related documents

· Requirements for import of active substances (API) – Q&A (Denmark)

· New requirements for active substances (ASs) imported into the European Economic Area (MHRA)

· Risk based escalation (MHRA)

· Business Engagement Assessments on Compliance Escalation Process

USA

· Draft Guidance for Industry on Pre-Launch Activities Importation Requests

· Guidance for Industry -Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug Inspection

· Monitoring Crude Heparin for Quality

WHO

· General guidance for inspectors on "hold-time” studies revised draft for comment

· Proposed updated text for GMP for pharmaceutical products

Members click here to download full update


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