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Regulatory perspectives with a global twist

Pharmaceutical and medical device leaders think globally when it comes to regulatory matters of importance to packaging.

Global currency and regs
Global currency and regs

Think of regulations and the U.S. Food and Drug Administration might first come to mind. Yet, when Healthcare Packaging asked packagers in the healthcare community about the current regulatory situation as it relates to packaging, the responses were more worldwide in perspective.

Packaging Hall of Fame inductee Edward Bauer, for example, noted, “From a medical device perspective, the lack of commonality between the U.S. and Europe is probably the biggest issue from the standpoint of regulations. Efforts have been underway to develop a more uniform standard, but up to now the regulatory agencies have not been willing to compromise and accept the same approach to qualification of products. Only one of many proposed ISO standards has been adopted. This has led to increased testing, longer approvals, and higher costs.”

Bauer continued, “Overall, regulations, particularly those that cover manufacturing and validation, have become more complex and more stringent. It is time for the regulators and the manufacturers to begin a more strategic assessment of what needs to be accomplished. It also requires better cost-justification of new regulations and their impact on healthcare costs. Both groups need to talk to each other and be less adversarial.”

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