By Julia Huang, Regulatory Affairs Associate, Bora Pharmaceuticals
Although regulations often vary by region, regulators intend to protect public health. Regulatory authorities are expected to carry out their public health mandates by facilitating the timely introduction of new medicinal products to meet society’s requirements. At the same time, they are responsible for protecting the public from products of suspect quality, safety, and efficacy.
Pharmaceutical products must undergo rigorous regulatory authority evaluation of the dossier or technical file that contains information on quality (chemistry, manufacturing and control (CMC)), safety (nonclinical), and efficacy (clinical) testing results before gaining market access.
With the majority of our clients in the United States, we at Bora work with the regulatory authority known as the US Food and Drug Administration (FDA) who exercise a legal right to control product transport, use, or sale within their jurisdictions. They do this by ensuring compliance with US laws, regulations, standards, and any post-marketing requirements. When a manufacturer (or applicant/ sponsor) plans to market their drugs in the US, a marketing application submission is required. Only after an official application is made to a regulatory authority, can market access be achieved. In general, there are two major types of prescription drug applications to obtain agency product approval, which are NDA and ANDA.