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
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
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
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
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