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News & Press: Regulatory Updates

PHSS Regulatory Update April 2014

01 April 2014  
Posted by: Tamsin Marshall
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PHSS Regulatory Update April 2014

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 Canadian, Japanese and USA regulatory authorities.

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

Europe

  • Ph. Eur Knowledge database
  • Guideline on process validation for finished products
  • MHRA and NHS England initiative to simplify adverse incident reporting
  • Guidance for pharmacists on repeal of exemption on wholesale dealer’s licences
  • Scientific advice survey
  • Perceptions audit

USA

  • FDA Commissioner calls for collaborative approach to health regulation at MHRA Annual Lecture
  • CMC Post approval Manufacturing Changes To Be Documented in Annual Reports
  • Bioavailability (BA) and Bioequivalence (BE) Studies Submitted in New Drug Applications (NDA) or Investigational New Drug Applications (IND) —General Considerations
  • Allowable Excess Volume and Labelled Vial Fill Size in Injectable Drug and Biological Products
  • Labelling for Human Prescription Drug and Biological Products Approved Under the Accelerated Approval Regulatory Pathway

International

Canada

  • Annual Inspection Summary Report

Japan

  • Documents to be submitted when applying for inspection
  • Japanese Pharmacopoeia – online

Conferences

  • PDA/PICs Training Course on GMP for APIs

 


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