EMA makes inspection reports public

The European Medicines Agency (EMA) is now making public its reports on companies that have failed plant inspections. The FDA has made warning letters and some Form 483 reports public for some years, but the EMA had not, according to Pharmafile, which went through the nearly 7 dozen reports in the database that date back to 2007. India accounts for 35 reports and China accounts for 22. Among the others, the U.S. had four, the U.K. had three, France had three and Brazil had two, Pharmafile reports. The database will also be used in a new program in which the EMA and U.S. FDA will share some responsibilities for inspections of generic drugmakers. Story | More