Industry news

NSF Health Sciences experts bring you the latest news updates from the industry

EU GMP Chapter 6, Quality Control, final version published

Wednesday the 16th April 2014

Revision of EU GMP Chapter 6 – Quality Control

The final version of a revised Chapter 6 was published in late March 2014 and becomes effective from 1 October 2014. The final version is almost identical to the draft revision that was published on 17 January 2013. This revision adds more empha...

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New FDA Guidance "CMC Post-Approval Manufacturing Changes to be Documented in Annual Reports"

Tuesday the 15th April 2014

FDA has published new guidance that describes chemistry, manufacturing, and controls (CMC) post-approval manufacturing changes that should be documented in an annual report.

This guidance consists of two lists published as Appendices. The first list, Appendix A, was developed using a risk-ba...

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Critical Decisions in Medical Devices

Thursday the 10th April 2014

The medical device industry faces dramatic changes in the way it is regulated, particularly in Europe. James Pink, Vice President Europe of NSF Health Sciences, discusses the challenges facing the quality professional.

Download the full article pdf

As featured in the April issue of Quality W...

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New EU Clinical Trial Regulation approved by the European Parliament

Wednesday the 9th April 2014

On 2 April 2014 the text of the new CT Regulation, which will replace the CT Directive 2001/20/EC, was approved by the European Parliament. The regulation is expected to be published in the Official Journal by mid-2014 and become effective in mid-2016.

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European Medicines Agency Launches Adaptive Licensing Pilot Project

Wednesday the 26th March 2014

To improve timely patient access to new medicines, the European Medicines Agency (EMA) launched a pilot project that employs an adaptive licensing approach to real medicines in development.

Adaptive licensing, sometimes called staggered approval or progressive licensing, is a prospectively pla...

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