Industry news

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

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...

Read more

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...

Read more

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.

Read more

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...

Read more

CDSCO (India) Announced That Imported Drug Products Must Meet Indian Medicinal Products Requirements

Tuesday the 18th March 2014

The Indian drug regulatory agency Central Drugs Standard Control Organization (CDSCO) announced on March 4 that drug products imported into India must comply with Indian requirements for the manufacture of medicinal products.

CDSCO has increased surveillance of medical products imported into I...

Read more

Quick links

NSF Health Sciences have offices in Kirkbymoorside and Sheffield, UK and Boston and Ann Arbor, USA

A word from NSF Health Sciences

The legislation and guidance that apply to the healthcare industries is forever changing. NSF Health Sciences will provide you with regular updates on what is new and will also provide you with expert interpretation of these changes - what they mean

Peter Gough

© NSF Health Sciences 2014

Registered Office: NSF Health Sciences, The Georgian House, 22/24 West End, Kirkbymoorside, York, UK, YO62 6AF
Registered in England and Wales No: 3432550 | Tel: +44(0)1751 432999 | Fax: +44(0)1751 432450 | Email: pharmamail@nsf.org
US Office: NSF Health Sciences, 6th floor, 129 South St, Boston, MA 02111 | Tel: 1-857-277-0060 | Fax: 1-857-284-7207 | Email: USpharma@nsf.org