Australia Proposes New Guidance On Regulating Boundary & Combination Products
The Australian regulator wants to hear stakeholders’ views on proposals to help decide whether a product is a medicine, a medical device or a biological – or none of the above.
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EU Review Proposals ‘Fail To Analyze’ Impact Of Reduced Exclusivity Periods
Plans for the overhaul of the EU’s medicines framework are missing key analysis on the effect of reductions in data and market protection on the pharmaceutical industry, despite an abundance of studies on how such incentives influence company decisions on whether to develop new products, say lawyers from Sidley.
EU Commission Again Delays Pharma Revision Proposals, Citing ‘Busy Agenda’
Two members of the European Parliament claim the latest delay to publication of the long-awaited legislative revision is the result of pressure from the pharmaceutical industry.
Australia To Seek Stakeholder Input On Terms Of HTA Review
The review of the health technology assessment system will look at the use of adaptable and flexible approaches to managing future health care technologies, early and equitable access for patients, as well as the possibility of international work-sharing initiatives and comparisons of purchasing practices.