The rapporteur for the draft directive that is part of the proposed EU legislative revision package says the pharmaceutical industry needs certainty and long-term predictability regarding the expected level of regulatory data protection. But her proposal to increase the RDP period is not shared by the rapporteur for the draft regulation.
Fears that the European Commission’s proposed overhaul of the pharmaceutical legislation will have a tortuous journey through the EU legislative machinery appear well grounded after the two rapporteurs for the European Parliament’s environment and public health committee (ENVI) took very different positions in their draft reports on the revision package.
Pernille Weiss of the center-right European People’s Party, who is rapporteur for the draft directive – part of the commission’s...
Nearshoring production and diversifying contract manufacturing networks can help companies stave off cost increases that will be reflected in higher medicine prices.
Eli Lilly and PharmaMar were set to make their case before the European Medicines Agency this week as part of re-examination procedures for their respective drugs Kisunla and Aplidin.
The European Medicines Agency’s, human medicines committee, the CHMP, is this week poised to issue opinions on potential marketing approvals for 17 products.
The European Medicines Agency is expected to decide whether to recommend EU-wide marketing authorization for six orphan-designated medicines that are all already approved in the US.
The European Medicines Agency’s, human medicines committee, the CHMP, is this week poised to issue opinions on potential marketing approvals for 17 products.
The European Medicines Agency is expected to decide whether to recommend EU-wide marketing authorization for six orphan-designated medicines that are all already approved in the US.
George Tidmarsh has extensive experience in the biopharmaceutical industry and led several drugs to FDA approval.
