A new package of measures from the European Commission will introduce an SPC export manufacturing waiver to help improve the competitiveness of Europe’s generics and biosimilars industry, while originator companies should benefit from steps to smooth out the rules on the “Bolar” research exemption and implement an EU-wide SPC.
The European Commission is expected to launch a consultation soon on proposed changes to the rules on supplementary protection certificates aimed at increasing the competitiveness of the EU generic and biosimilar industry while ensuring that SPCs remain a strong incentive for originator companies to carry out R&D into new drugs.
The package of proposals includes introducing a waiver that would allow EU-based generics firms to manufacture for export...
The US FDA Commissioner pushed for a rebalancing of the US’s pharmaceutical supply chains while also stressing that there is a role for US-China commerce that would be risky to compromise.
The UK regulator approved 16 medicines containing a new active substance in the first half of this year, while the European Commission issued marketing authorizations for 20 NAS-containing drugs.
Joint clinical assessment reports must be descriptive rather than reach definitive conclusions, and must not interfere with national decision making processes, according to new EU guidance.
The agency’s plan for advanced manufacturing seeks more harmonization, while also seeking to codify internal practices with guidance and training.
Joint clinical assessment reports must be descriptive rather than reach definitive conclusions, and must not interfere with national decision making processes, according to new EU guidance.
Developments in India and Pakistan are designed to standardize how drug companies disclose their expenses associated with health care professionals.
The agency’s plan for advanced manufacturing seeks more harmonization, while also seeking to codify internal practices with guidance and training.
