U.S. and EU NME/NAS Submissions Hit Five-Year High in 2004

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,

1995-2004

                                                FDA                            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

Source: PAREXEL’s Pharmaceutical R&D Statistical Sourcebook 2005/2006 (www.barnettinternational.com)

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.