Abstract
Clear regulatory planning during the early stages of product development is essential to develop a focused regulatory strategy that can be presented to national regulatory authorities (NRAs). NRAs regulate pharmaceutical products to enable patient access to high-quality, safe, and effective products, and restrict access to those products that are unsafe or have limited clinical use. Regulatory procedures affect all stages of biomedical product development. Detailed safety review during research and development stages, regulatory approval, and legal registration are necessary stages of product development. When appropriately implemented, regulation ensures public health benefit and the safety of patients, healthcare workers, and the broader community. Therefore, it is critical that developers of biomedical products (drugs, biologics, devices, in vitro diagnostics, or some combination) possess the knowledge and awareness of the regulatory challenges and opportunities to expedite the development of safe and effective products in a cost-effective manner.
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