Companies Get 19 EU Paediatric Extensions in 2016, But Many Firms Miss Trial Completion Deadlines
Executive Summary
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.
You may also be interested in...
Norway To Grant Pediatric Extensions Of SPCs From Sept. 1
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.
Industry & Regulators To Align Advice on COVID-19 Vaccine Updates
A multi-stakeholder workshop looked at the data needed to support updates to vaccine composition and the time required by manufacturers to update their vaccines, change their manufacturing processes and prepare approval applications.
Denmark Planning To Impose Drug Stockpiling Obligations From July
A new bill is intended to address the increase in medicine supply problems in Denmark in recent years.