Within 10 years, reporting will be risk-based across a broad spectrum of products, and pharmacovigilance procedures will be an integral part of a product's development plan. Companies must anticipate [this] and build the foundation for processes that easily accommodate change.
The great visionary Buckminster Fuller once said: "To change something, build a new model that makes the existing model obsolete." Increasingly, regulatory agencies in both the U.S. and EU are following this paradigm and constructing a new evaluative model of reporting requirements. For example, we have seen a significant focus on risk management and reporting prioritisation of products based upon their risk profile. Nostrapharmus says "industry must be prepared for this impact, not only on business operations for a traditional product portfolio, but also for medical devices, over-the-counter (OTC) drugs, cosmetics and any animal health products in their portfolio."
Regulatory Change
Both the US and EU have demonstrated an increased focus on risk-based product evaluation and reporting with recent regulatory amendments; the US has done so most notably with the Food and Drug Administration Amendments Act of 2007 (FDAAA), and the EU with proposed legislative amendments to directive 2001/83/EC and regulation (EC) 726/2004.
In the US, the FDAAA establishes that a Risk Evaluation and Mitigation Strategy (REMS) may be required to ensure that benefits will outweigh the risks of a drug. In addition, the emergence of ‘new safety information’ or ‘information necessary to ensure that the benefits of the drug outweigh the risks of the drug’ may prompt the FDA to request a REMS.
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