The Importance of Global Regulatory Strategy in Drug Development

The pharmaceutical industry is responsible for the development, production and marketing of medical drugs, both in North America and around the world. While North America is considered an industry leader— generating the largest portion of pharmaceutical revenue worldwide—growth markets including China, Latin America and more have grabbed the attention of large pharmaceutical companies who are looking to expand their global footprint.

When pharmaceutical companies decide to develop their products globally, one step that’s involved is creating and coordinating a regulatory strategy. Regulatory industry professionals understand that doing so saves time and money, and provides consumers with quicker and easier access to the medications they need. Read on to learn more about global regulatory strategies, and their purpose in the pharmaceutical industry.

Understanding Regulatory Strategy as a Regulatory Affairs Professional

Individuals pursuing pharmaceutical regulatory affairs training understand that a regulatory strategy is an essential part of the early development of any pharmaceutical drug. An effective regulatory strategy serves to align a proposed clinical development plan with business objectives—generally aimed at worldwide distribution. The strategy also helps identify any potential challenges, and offers solutions or alternative approaches to new product development. An additional intent and purpose of a regulatory strategy is to find ways of offering and selling drugs to a wider array of patients to increase global access to medication.

Why Pharmaceutical Regulators Need a Global Regulatory Strategy

Experts holding a pharmaceutical regulatory affairs diploma know that the main goal of a global regulatory strategy is to develop a worldwide distribution plan that incorporates all of the major pharmaceutical markets, such as the United States, Europe, Japan and China. With a population of 4.3 billion, Asia, and China in particular, has no doubt become a major player in the pharmaceutical industry.

Since each market generally follows its own regulatory requirements, creating a single plan that will work across all markets can be quite challenging. As a growing trend, the legal framework and regulatory processes in many of the emerging markets has been evolving, and is now becoming more aligned with US and European legislation. For instance, the regulatory agency in China and South Korea has recently been raised to the ministry level, meaning that the government (rather than independent companies) has more control over pharmaceutical regulation.

How Regulatory Professionals Make Global Regulatory Strategies Work

Students enrolled in pharmaceutical regulatory affairs courses know that there are several approaches for effectively managing various regulatory standards and requirements across different markets. In fact, Bayer, a German multinational pharmaceuticals company, has found one very effective way of handling varying standards. The German corporation works with a local partner called Covance to ensure that all required and proper regulatory steps are maintained internally.