Some time ago, on another thread, one of those types that likes to point out perceived errors in other's postings yet never really contributes anything to the conversation, queried about the differences between US and UK drug approval. I poked around various UK ministries' sites and never found anything as nice as the FDA's guidance. Did; however, find this. A bit dated:
Office of Planning and Evaluation
Approval of New Drugs in the United States
Comparison With the United Kingdom, Germany and Japan
David A. Kessler MD, JD; Arthur E. Hass; Karyn L. Feiden; Murray Lumpkin, MD;
Robert Temple, MD
Originally published in Journal of the American Medical Association,
December 11, 1996 - Vol 276, No. 22
Abstract
The marketing approval dates of 214 drugs newly introduced into the world market from January, 1990 through December, 1994 were compared in 4 countries. The analysis reveals that the United States and the United Kingdom have similar patterns of drug availability, although the United States has a number of therapies with significant public health benefits that are not yet available in the United Kingdom. The findings also show that the United States outpaces both Germany and Japan in approving important new drugs. Various strategies adopted by the Food and Drug Administration to expedite its pharmaceutical review process, including the use of industry user fees, are described.
For a reprint of the JAMA article, write to: Office of the Commissioner, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857.
The Database
A link to the complete database used to compare recent new drug approval activity in the United States, the United Kingdom, Germany and Japan is provided here to allow subset analyses. The data is in a fixed width font (Courier) and can be cut and pasted into any text reader or a spreadsheet for analysis.
The first column (NEW DRUG NAME) in the table identifies the name of the drug as reported by Scrip World Pharmaceutical News or Scrip Magazine and includes occasional notes. The list is sorted alphabetically by drug name within five groupings -- the frequency of approval (0, 1, 2, 3, 4) among the four countries studied.
The second column (PRIORITY ?) identifies those drugs which the FDA classified as priority review.
The third column (1ST MKT) identifies the country where the drug was first marketed as reported by Scrip World Pharmaceutical News or Scrip Magazine. The fourth column (SCRIP YEAR) identifies the calendar year in which the drug was first marketed as reported by Scrip World Pharmaceutical News or Scrip Magazine.
Column five (NUMBER OF APPROVALS) notes the number of approvals for each drug among the four countries studied as of April 1995. Columns six through nine (USA DATE, etc.) report the approval date for each of the four countries studied where applicable. The most specific information provided by the various regulatory authorities is reported. This information was sufficient to determine rank order of approval in all cases.
Columns ten through 13 (USA RANK, etc.) identify the rank order of approval for each drug among the four countries studied.
SI did not like posting database, database can be found at:
fda.gov |
