Research-Based Pharma Urges Redress From Negative Impact Of EU SPC Waiver
Executive Summary
The research-based pharmaceutical industry has issued a severe warning that the European Parliament's overwhelming support for IP-related changes that will allow manufacturing of generics and biosimilars during the term of supplementary protection certificates will hit innovation. Some of industry's concerns may be justified, a patent attorney explains.
You may also be interested in...
EU SPC Waiver: Originators May Need To Act Soon
A new EU regulation relaxing the rules on generic and biosimilar manufacturing during a product’s supplementary protection certificate period will take effect on 1 July. Originator companies wanting to benefit from a three-year transition period should consider taking action now.
Global Pharma Guidance Tracker – March 2024
Stay up to date on regulatory guidelines from around the world with the Pink Sheet's Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.
EU Regulators Explain How To Ensure Transitioned Trials Align With CTR
Members of the EU’s Clinical Trials Coordination Group have developed harmonized requirements for updating trials that are transitioned to the Clinical Trials Information System based on a minimum set of documents.