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Easy as eCTD?

The pharmaceutical market is one with high rewards. It has been reported that pharmaceutical spending growth should match health spending growth at an average of 4.3 percent during 2015- 2019, and global pharmaceutical sales should reach $1.4 trillion (€1.18 trillion) by 2019. Biotech drug sales reached an estimated $289 billion (€244 billion) in 2014 and are projected to grow to $445 billion (€375 billion) by 2019. In addition, biotech’s share of worldwide prescription drug and over-the-counter sales is projected to increase from 23 percent in 2014 to 26 percent in 2019 (1).

On average, it takes around 12 years for a new drug to go from invention to market. During this time, a tremendous amount of information about the molecule will be collected. If a drug is ultimately successful in clinical studies, the pharma manufacturer will seek regulatory approval via a Marketing Authorization Application (EMA) or New Drug Application (NDA), which should demonstrate the analysis of data obtained during development. These applications are complex, lengthy documents; in the 1990s, a typical MAA consisted of at least 100,000 pages. To standardize the application dossier, the Common Technical Document (CTD) was developed by the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), in collaboration with the EMA, FDA and Japanese Ministry of Health, Labor and Welfare.

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About the Author

Pallavi Trivedi

Pallavi Trivedi is a regulatory consultant at Morningside Healthcare, UK, and an active member of the Regulatory Affairs Professionals Society (RAPS) and the RAPS European Council (REC).

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