Over the next year, I'll be tackling some of the region-specific challenges that pharmaceutical companies face in a new BioPharm International column. This introductory article provides some key considerations for navigating and managing diverse market and regulatory trends across the globe in a consistent manner.DEVELOP A COMMON APPROACH TO NAVIGATING REQUIREMENTS
The globalization of pharmaceutical markets has fueled an emphasis on improving the regulation of these industries across developed and developing countries. Ideally, steps towards harmonization would be among the goals of improving regulation. Countries are instead taking independent strides at varying paces to improve the regulation of markets that are very different from each other. Across the board, submission requirements vary and enforcement resources are limited, which can contribute to frustrating waiting periods and prolonged product-approval timelines.
This degree of regulatory variability may seem daunting, but approaching regional requirements in a consistent manner can make the process more manageable. Although regulatory oversight and enforcement varies from country to country, there are common regulatory steps that play an integral role in shaping each stage of the product development, approval, manufacturing, and marketing lifecycle. Regardless of the region or product in question, the regulatory process will likely involve the following: product classification, preclinical testing, clinical evaluation, product registration, manufacturing/production approval, quality system management, and compliance with good manufacturing practice (GMP) as well as good clinical practice (GCP), and good laboratory practice (GLP).
At each step in the regulatory process, authorities may establish approval requirements, regionally accepted best practices, recognized credentials and certifications, and/or quality system requirements. The controls that are put in place at each step in the regulatory process can—and will—differ from country to country, and from product to product. Being able to identify and understand these controls for any given country or region will be crucial because they may have implications for timelines, processes, cost, and revenues.
Moreover, understanding the nature and stringency of these regulatory measures will be important. These factors may impact how effectively a product can be brought to market in other regions, under a completely different set of regulatory requirements.