Drug Developers “Facing Complex Global Regulatory Requirements”

Experts have warned that as pharmaceutical and biopharmaceutical companies increase the number of clinical trials they conduct in emerging global markets, growing regulatory complexity is forcing them to change the way they operate.

“What a company does in one region can very likely affect how regulators treat it elsewhere,” according to Christopher-Paul Milne, associate director of the Center for the Study of Drug Development (CSDD) at Tufts University, Boston, Massachusetts.

“Understanding local regulatory requirements and trends, and how competitors’ activities are shaping those trends, has become a minimum requirement for engaging in global drug development,” he says, commenting on the findings of the Tufts CSDD Executive Forum Roundtable, a panel of leaders from the research-based pharmaceutical industry convened recently by the Center.

Flexibility may be the decisive success factor when it comes to drug development strategy, according to Mr Milne, commenting that “what’s true today in the regulatory environment in a particular region may not hold sway when trials are completed in a few years’ time, requiring a rapid shift in development strategy”.

The number of pre-clinical and clinical studies in process around the world grew rapidly during the last decade – from approximately 4,900 in 2000 to 8,600 in 2010 (Tufts CSDD). This fast growth has, in turn, put pressure on regulatory authorities to keep up with additional demands relating to monitoring studies and reviewing results.

The Roundtable panel also found that this advancing regulatory complexity is generating increased amounts of data, which requires drug developers to improve the way they manage their information. Moreover, they say, the success of regulatory affairs groups within drug development companies will depend on their ability to understand and respond, on a global basis, to the sometimes-conflicting requirements of regulatory agencies and authorities.

The industry panel also advises drug developers that they need to solicit the views of new stakeholders, including payers and patients, and to incorporate their perspectives into their drug development programmes at an early stage, in order to be able to properly define their product development plans.


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