Refurbished EU GMP guideline for drugs effective March 2015
This article was originally published in SRA
Executive Summary
The European Commission has made a raft of revisions to its good manufacturing practice (GMP) guideline that deals with basic requirements for medicinal products.
You may also be interested in...
Risk-Based Contamination Limits Suggested For Highly Potent Drugs
As more highly potent and highly toxic drugs are being developed, regulators are looking into risks posed by contamination of non-contact surfaces, yet until recently, there was scant guidance on how to assess these risks.
WHO Examines Ethical Criteria For Human Challenge Trials Ahead Of Next Health Emergency
The World Health Organization is looking to finalize its guidance on the ethical criteria that should be applied to studies that involve deliberately infecting healthy individuals to speed up research.
EU Consults On What Constitutes Personal & Commercially Confidential Data In Marketing Applications
Based on their experience with dealing with requests for access to documents over the past 12 years, EU regulators have proposed updating their guideline that provides for a harmonized approach to protecting personal data and business secrets in marketing authorization applications.