Increase in Pharmaceutical Companies Outsourcing Regulatory Affairs Budgets
News Jan 10, 2013
A majority of surveyed pharmaceutical companies outsource at least part of their regulatory affairs budget. This is up 5% from 2010, demonstrating that fewer drug companies are trying to keep such activities entirely in-house than before, according to a recent study by Cutting Edge Information. The study, “Regulatory Affairs: Safeguarding Submission Success and Product Development Strategy,” found that the industry is beginning to find benefit in hiring experienced contractors for many regulatory affairs tasks. The percentage of budgets being outsourced remains low—usually hovering between 10% and 20%, with a few outliers hiring vendors to perform more tasks than most companies tend to.
All surveyed Top 20 pharmaceutical companies reported outsourcing at approximately 10% of the overall regulatory affairs budget. Tasks that Top 20 companies outsourced included publishing, labeling or tracking changes to regulatory guidelines. Most companies also use vendors for post-market surveillance tasks, preferring to keep products that are still in development more close to the vest. However, contract research organizations (CROs) that Cutting Edge Information interviewed championed their ability to give investigational products the attention they deserve, despite drug manufacturers’ doubts.
“One CRO estimated its dedicated regulatory affairs headcount at 240 full-time equivalents (FTEs),” said Ryan McGuire, research team leader at Cutting Edge Information. “Their staff has experience with the regulations regarding global clinical trials. For some companies, it may be worth using this expertise during drug development.”
“Regulatory Affairs: Safeguarding Submission Success and Product Development Strategy” (http://www.cuttingedgeinfo.com/research/regulatory/market-approval/) contains resource benchmarks, strategic recommendations and best practices for building a strong regulatory affairs team and improving regulatory submission timelines. The study also delves into the topic further to find which regulatory functions companies commonly outsource, how much money they divert to them and why.
It is designed to guide key decision-makers to:
• Overcome hurdles in your regulatory process to move your products to market as soon as possible.
• Position regulatory affairs at the center of strategic activity.
• Benchmark the most desired skills for regulatory affairs employees and hire accordingly.
A widely used diabetes medication combined with an antihypertensive drug specifically inhibits tumor growth – this was discovered by researchers two years ago. In a follow-up study, recently published in “Cell Reports”, the scientists report that this drug cocktail induces cancer cell death by switching off their energy supply.READ MORE
The cholesterol-lowering drugs called statins have demonstrated substantial benefits in reducing the risk of heart attacks and strokes caused by blood clots (ischemic strokes) in at-risk patients. Since statins are associated with a low risk of side effects, the benefits of taking them outweigh the risks, according to a scientific statement from the American Heart Association that reviewed multiple studies evaluating the safety and potential side effects of these drugs.READ MORE
18th International Conference on Pharmaceutics & Novel Drug Delivery Systems
May 27 - May 28, 2019