The much-criticized delay in the removal of marketing authorization for Servier’s Mediator in France has had profound implications for reform of the country’s regulatory system.
Key regulatory developments include the new Prescription Drug User Fee Act (PDUFA-V), which aims to improve interaction between the FDA and drug developers.
Historically Japan has been plagued with delays, with new drug approvals sometimes taking three or four years longer than in the US and EU.
Already high and rising healthcare expenditure coupled with unfavorable demographic dynamics are prompting the German government to introduce changes in order to ensure healthcare system sustainability.
France spent more of its gross domestic product (GDP) on healthcare in 2010 than the average of other key developed markets.
Recently there have been several new regulatory changes in the UK aimed at reducing the regulatory burden and allowing earlier access to medicines which are seen as a positive development for the pharmaceutical industry.
Continued growth in healthcare expenditure and the high number of individuals without health insurance coverage were the key drivers of the passage of the healthcare reform law.
Generally considered the domain of developed markets, health technology assessment (HTA) is increasingly being used by developing countries as a means of reconciling growing demand for access to health technologies with limited resources. Expanding public health insurance programs, coupled with aging populations and growing patient empowerment, have led in some cases to the fast establishment […]
With a growing economy and 40 million inhabitants, Argentina is one of the most important emerging market destinations in South America.
Reform of the NHS is underway despite widespread controversy and opposition from physicians, and will necessitate a change in the way pharmaceutical companies work with key stakeholders.
The market environment in Spain is extremely challenging, with cost-containment measures introduced in 2010–12 contributing to an overall reduction in pharmaceutical spending.
India is one of the most important emerging pharmaceutical markets, and the market is forecast to more than double between 2011 and 2017, growing at a compound annual growth rate of 16.1%.
With the entry of the first monoclonal antibody biosimilar in most European markets and approval of the first biosimilar in the US, 2015 promises to be a landmark year for the biosimilars market. The savings potential of biosimilars in a time of constrained healthcare budgets is an attractive value proposition for many payers, and regulators’ positive stance in terms of making the approval and development process as efficient as possible is advantageous for the sector.
Prescribing by international non-proprietary name, pharmacist incentives, and the high price differential between the brands and their generic alternatives are the key drivers of the generics market in the UK.
Payers and governments are striving toward cost-effective treatment outcomes and more efficient care, and waves of new digital health technologies are offering patients unprecedented opportunities to be more engaged in their own health management.
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