Today we have launched a new Infographic that highlights the state of drug approvals in 2013 in Europe and the USA.
The new Infographic draws on official data released from the EMA and the FDA, and focuses in on the following key findings:
? The differences in drug approvals between the USA (FDA) and the EU (EMA)
? Breaks-out results by therapeutic areas
? Compares the time taken to get drugs approved, and shows the significant difference in drug approval times between the EU and the US
? Shows the percentage of top pharma vs the rest of the industry in gaining drug approvals
? Breaks-out those that received ‘Special Status’ in the EU and the USA
The Infographic is available on NDA’s website.
NDA media contact: Paula Warmer, e: firstname.lastname@example.org, m: + 44 (0) 7713 308314
NDA is an independent consulting group based in Germany, Sweden, United Kingdom and USA. Its mission is to ensure that good medicines reach patients without unnecessary delay. It accomplishes this by providing the pharmaceutical industry with a comprehensive range of professional services within regulatory affairs, health technology assessment, pharmacovigilance and quality assurance. NDA’s team comprises more than 25% ex-regulators from major EU Agencies, plus two specialist Advisory Boards, consisting of Europe’s leading regulatory and HTA experts. They are there to provide scientific advice to pharmaceutical companies supporting them in gaining fast and constructive assessment of drug approval applications from European regulatory agencies and payer bodies.
The client is developing a pipeline of biosimilar monoclonal antibodies for approval in Japan, EU and US. While the regulatory pathway is well-defined in the EU, the pathway to approval of biosimilar products is at a much earlier stage in US and Japan. Although some requirements appear to be aligned across most phases of development, there are still are still major differences in the regulatory requirements from the different regions.