New regulations raise questions across Europe
by Ken Allen, on April 3, 2015
Much of Pharmapack Europe focused on new regulations in medical devices and injectables, with questions raised about what exactly these new regulations will address and how to meet compliance. According to Packaging World, the majority of companies in these sectors already meet GS1 standards, but may need to revise their regulatory strategy in the near future to maintain that compliance.
"The revision of medical device directives is going to create periods of upheaval and new constraints, but it can also bring real opportunities to companies," Joel Guillou, Consultant Regulatory Affairs and Market Access and Director, International Society for Pharmaceutical Engineering France, said at the conference.
Some of the coming changes include: Unannounced audits, new rules for clinical evidence, post-market clinical follow-up and unique device identification.
Other experts in this industry say that while the current standards have allowed or the impressive growth of the medical industry, the changes are much needed improvements to maintain safety while still promoting that growth.
Despite the importance of these changes, there are many issues to still overcome with the new regulations. Furthermore, many manufacturers are unsure if they should hold off on launching new products, as their packaging and labeling needs much change mid-launch.
Many cite the burgeoning counterfeit black market as a major driver of the push for these new standards. Counterfeit pharmaceuticals is a multi-million dollar global market that creates series health and economic risks. The sooner better regulations can fall into place, the better it will be for everyone involved.
Adopting higher-quality labeling solutions is just part of the problem, firms also need to ensure the tools they use meet current standards and are flexible enough to adapt to future changes.