Regulatory Strategy: Current Global Regulatory Strategies: The Convergence of Opportunities, Challenges and Ethics
Posted 01 November 2009 | By
The past few years have seen the rise of several distinct, yet additive elements that impact the effectiveness of a global regulatory strategy for marketing new drug products. These include a clinical and regulatory focus on personalized medicine, as well as recognition of the growing opportunities for developing innovative products in emerging global markets. Awareness of the need to implement strategies that extend beyond the traditional steps historically required that demonstrate a drug's safety, efficacy and positive benefit-to-risk prior to receiving marketing authorization is becoming necessary. These new challenges and opportunities are the result of the rapidly changing global environment, which is being shaped by new, innovative science, emerging socioeconomic regions and multiple intrinsic and extrinsic aspects such as product safety, benefit-to-risk, branding and reimbursement, all working in concert to reshape the regulatory environment.