Qvents

Qvents

Discussion forum for Pharma Quality events, Regulatory Actions

Warning letters, 483s, Recalls, Import Alerts, Audit observations

EMA To Review Finasteride and Dutasterid

The European Medicines Agency (EMA) has initiated a review of finasteride and dutasteride due to

EMA Updates list of N-Nitrosamines

EMA(Europeans Medicines Agency) has updated the Appendix 1 Acceptable intakes established for N-nitrosamines with 15

USFDA and EMA Parallel Scientific Advice

Prospective applicants of Complex Generics (CG) can request for a joint meeting with FDA OGD

European GMP and GDP certificates validi

The GMP/GDP Inspectors Working Group coordinated by EMA has decided to continue the extension of

European Commission (EC) publishes list

The European Commission has published the first Union list of critical medicines, together with the

EMA, the European Commission (EC) and th

EMA, the European Commission (EC) and the Heads of Medicines Agencies (HMA) are phasing out