White Paper

Complex global regulations bring new challenges to CMC compliance

Insights to improve drug submission success

While globalization has led to many new opportunities for developers of lifesaving medicines, it has also created new challenges when it comes to determining the many regulations that must be followed in order to successfully launch products into new markets.

On top of the many differences from country to country, the regulatory landscape is constantly evolving, which forces many drug developers to implement costly and time-consuming processes in order to track the countries in which they currently market their products as well as any countries targeted for expansion.

This is especially an issue when it comes to planning the chemistry, manufacturing and controls (CMC) module of an investigational or a new drug submission, as manufacturers must precisely meet the requirements from different health authorities or they run the risk of having their drug submission rejected.

  • 50% – The percentage of first NME applications that were rejected between 2000 and 2012.1
  • 11.3% – The percentage of first-cycle review rejections due to CMC-related issues.1
  • 18.3% – The percentage of rejections that were delayed again following resubmission due to CMC-related issues.1
  • 5% – The percentage of drugs never approved due to CMC-related issues.1

Download the full report to learn more about the resources CMC professionals now have to increase their submission approvals.

1. https://jamanetwork.com/journals/jama/fullarticle/1817795