Cutting Edge Information Finds Regulatory Affairs Difficult Both at Home and Abroad

A recent study explores challenges faced by pharmaceutical companies in their interactions with regulatory agencies

RESEARCH TRIANGLE PARK, N.C.--(BUSINESS WIRE)--Half of all drug companies surveyed by Cutting Edge Information said that their regulatory affairs team interacts with correspondents in the FDA once a week or more.

“However, most companies surveyed in the study are US-based, and as such have more experience with the FDA than with other regulatory bodies.”

Of the remaining corporations who interact with them less frequently, 23% still speak with the FDA at least once a month. Most regulatory affairs groups recognize the importance of keeping frequent contact with regulatory agencies, and doing so build better relationships that help drug companies better prepare submission packages for regulatory approval.

The nature of these interactions is often more informal than not. Keeping good relations with individuals within the agency and being able to stay on top of potential issues and confusing regulations are important advantages that more and more pharmaceutical companies realize come from regular communication with regulatory affairs groups.

“Seasoned regulatory affairs groups find opportunities at conferences or industry meetings to engage regulatory agencies,” said Ryan McGuire, research team leader at Cutting Edge Information. “However, most companies surveyed in the study are US-based, and as such have more experience with the FDA than with other regulatory bodies.”

The majority of these same companies rated the harmonization of clinical trial submissions and ex-US agency requirements as the most challenging aspect for regulatory affairs teams. One of the reasons this can be so difficult is pharmaceutical executives’ decisions to group regulatory affairs teams by geographic region rather than regulatory similarity. Another reason for these challenges is most apparent in developing markets where the regulatory requirements tend to change radically, frequently and without warning. Although it’s not quite as clear as in developing countries, surveyed executives also reported having trouble with the increasingly difficult requirements from the FDA and other established regulatory agencies.

Cutting Edge Information’s report, “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. It guides key decision-makers to:

• Benchmark the most desired skills for regulatory affairs employees and hire accordingly.
• Overcome hurdles in the regulatory process to move products to market as soon as possible.
• Position regulatory affairs at the center of strategic activity.

For more information, contact Cassie Demeter at [phone].