The global market for pharmaceuticals continues to grow rapidly, and in response, manufacturers are moving to align their
market strategy and product pipeline to meet emerging, unmet needs. Companies exploring opportunities in global markets face
dynamic demographic and disease trends, changing market demands, and evolving regulatory requirements—all of which differ
from one country to another. This complex environment makes planning for global market entry into both developed and developing
countries a moving target.
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In the face of such complexity, organizations need to be prepared to navigate constantly changing, inconsistent, and diverging
regulatory and market trends in a structured, but flexible manner that minimizes rework and maximizes value. Whether the goal
is to outsource the manufacture of US products to India to lower costs, or to market imported or domestically developed products
in China, a consistent approach for understanding market trends and navigating foreign regulation of pharmaceuticals is crucial
for developing a successful global market strategy. With that said, it is important to allow for variability in regional requirements
(sometimes even within a single country), market demands, and product pipelines.
Jill E. Sackman
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.