Drug safety regulations increase need for industry resources and expertise
Safety requirements for drug manufacturers now extends through drug lifecycle, requiring more resources to track safety post-sale as well as building it in during design and manufacturing.
According to the report, “Safety First: The Impact of New Regulations on Clinical Development,” drug safety leaders in pharmaceutical and biotechnology companies recognize the need to increase resources, either internally or through partnerships, to comply with the safety regulations recently issued by the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMEA). The report is based on a survey of 140 industry safety specialists, including heads of medical, drug safety, and regulatory departments within large and mid-sized pharmaceutical companies and biotech firms. The survey found that more than three-quarters (77%) of respondents believe that new safety regulations have had a considerable impact on the industry as companies implement drug safety regulations throughout the clinical development process.
The FDA and EMEA have recently introduced more rigorous safety regulations, with a particular emphasis on post-marketing surveillance, to ensure that medications are monitored for their safety and effectiveness over the long term, across wide populations, and in real-life settings. The survey findings also highlighted regulatory departments as having the most immediate need for greater resources, with more than half of those surveyed (53%) saying they’ll need more help within the next six months.
"The transition from performing passive post-marketing surveillance to active safety monitoring using Phase IV studies, safety registries and comparative effectiveness programs, is to ensure that benefit/risk re-assessment continues as safety information on the real-world use of products is revealed. Although initially resource intensive, this more rigorous approach to obtaining and analyzing post-approval safety data will better ensure the public's confidence in a product's true safety profile. The real challenge will be to find better tools and novel approaches to implement the requirements of regulations efficiently and cost effectively," says Dr. Suzanne Gagnon, Chief Medical Officer, ICON Clinical Research.
The report was commissioned by ICON plc, a global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries, and developed by IMS Health, a provider of market intelligence to the pharmaceutical and healthcare industries.
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- Edited by David Greenfield , editorial director