Recent high-profile public health concerns have resulted in a push for more aggressive and proactive regulation in many sectors. But should this be at the expense of many of the procedural safeguards that most companies and individuals have enjoyed historically?
In the pharmaceutical sector, a raft of recent laws and guidelines have enhanced regulators’ ability to monitor the safety of medicines and to take necessary action. Most of these changes are clearly steps forward. Regulators and manufacturers must now manage risks proactively. All applications for marketing authorisation must include a risk management plan that identifies and quantifies risks and proposes steps to manage them. Monitoring of product safety has also evolved from a formulaic review and submission of adverse event reports into a more holistic assessment of a product’s safety and its evolving risk-benefit profile.
