EU directives lose out in the Czech transposition
This article was originally published in Clinica
Executive Summary
The Czech transposition of the European Union's Medical Devices Directive could cause problems for industry. Draft legislation due to be submitted to the government in March or April is likely to contain a number of additional requirements to those already in place in the European Economic Area. The government decree that came into effect on October 1 has already introduced some measures that will have a negative effect on importers of medical devices into the Czech Republic.
You may also be interested in...
US FDA Drugs Center Ready To Break Down Silos On Regulatory Innovation
CDER Director Cavazzoni is promising to increase coordination and collaboration to accelerate broader adoption of innovative clinical trial designs and other approaches to speed drug development. A new "Quantitative Medicine Center of Excellence" illustrates the approach.
New OSP Director To Guide CDER-Wide IT Upgrades; System Enhancements Speed ANDA Assessments
Generic Drug Structured Assessment for Bioequivalence launched in 2023 and has been used in 40 ANDA reviews so far.
New EU Approvals
The Pink Sheet's list of EU centralized approvals of new active substances has been updated to add two new products, including Ryzneuta, Evive Biotechnology's treatment for chemotherapy-induced neutropenia.