The Regulatory Dilemma in the Gulf Region: The Way Forward

Abstract

The availability of new medicines is influenced by different stakeholder perspectives including those of the regulators, policymakers and the pharmaceutical industry. These differences are reflected in the historical high-profile drug withdrawals and the rising demand for improving medicines development to protect patients from the predictable harms of adverse drug reactions. This issue has gained impetus in recent years due to societies in general becoming more risk averse. This is challenged by certain patient associations and advocacy groups for chronic or life-threatening conditions who would be willing to accept higher risks as a trade-off for improved benefits. Problems with the safety and efficacy profiles of medicines continue to be an issue despite the regulations that aim to maximise the benefit-risk balance of medicines before they are made available to patients. The pharmaceutical industry is under pressure to fulfil the regulatory requirements for marketing purposes, whilst regulators are being encouraged to reduce the registration requirements and to accelerate the approval of new medicines demanded by patients. This gives credence to the current initiative concerned with new adaptive pathways.