Norway To Grant Pediatric Extensions Of SPCs From Sept. 1
Executive Summary
Norway has acted swiftly to amend its national legislation to allow six-month pediatric extensions to supplementary protection certificates as of Sept. 1, when the EU Paediatric and SPC Regulations will take effect in the country. Also, transitional arrangements have been put in place that will allow certificates expiring between March 1 and Aug. 31 to become valid again.
You may also be interested in...
Companies Get 19 EU Paediatric Extensions in 2016, But Many Firms Miss Trial Completion Deadlines
A report from the European Medicines Agency shows that in 2016, 19 products were awarded a six-month extension of their supplementary protection certificate for conducting pediatric trials, while the amount of scientific advice offered for pediatric medicines continued to rise.
Simplified Clinical Trial Transparency Rules To Go Live In The EU In June
A new version of the EU Clinical Trials Information System’s public portal will integrate the functionalities of the streamlined transparency rules.
WHO Examines Ethical Criteria For Human Challenge Trials Ahead Of Next Health Emergency
The World Health Organization is looking to finalize its guidance on the ethical criteria that should be applied to studies that involve deliberately infecting healthy individuals to speed up research.