The pharmaceutical industry’s new molecular entity (NME) submissions to the U.S. FDA and new active substance (NAS) submissions to the European Medicines Evaluation Agency (EMEA) rose to five-year highs in 2004, according to PAREXEL’s Pharmaceutical R&D Statistical Sourcebook 2005/2006.
The FDA received 31 NME submissions in 2004, while the EMEA received 45 NAS submissions under its centralized registration procedure, through which a drug can gain access to all 25 countries in the European Union via a single approval.
NME/NAS submissions at the FDA and EMEA, which are the regulatory gatekeepers to the world’s two largest pharmaceutical markets, have risen in each of the past two years after bottoming out in 2002.
The NME/NAS submission metric peers further back into the pharmaceutical industry’s new drug development output than the more commonly quoted metric: NME/NAS approvals. And since it is generally accepted that over 80 percent of the NMEs submitted to the FDA are ultimately approved, it provides a preliminary benchmark of likely new drug approvals by the FDA and EMEA in upcoming years.
In the United States, the pharmaceutical industry’s 31 NME submissions in 2004 represent a 23% rise from the many-year low of 24 in 2002. And although the 31 NME submissions equal a five-year high (matching the number in 2000), they remain far off the record levels seen in the mid-1990s.
Annual Number NMEs Filed with U.S. FDA and
NASs Filed with the EU’s EMEA,
1995 48 --
1996 45 --
1997 42 --
1998 43 --
1999 38 --
2000 31 40
2001 30 40
2002 24 26
2003 28 36
2004 31 45
The two-year rise in NAS submissions to the EMEA has been far more dramatic. NAS submissions rose 25% in 2004, and are up 73% over the last two years.
PAREXEL's Pharmaceutical R&D Statistical Sourcebook 2005/2006 is now available at www.barnettinternational.com.
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Last updated on: 27/08/2010