Simplified CP is essential for EU enlargement, say CADREAC states

The simplified European Union Centralized Procedure for the approval ofmedicinal products, which has been made available to EU candidate countries since January 1, 1999, is now widely used and has been well accepted, according to Anu Tummavuori of Hoffmann La Roche.

Speaking at the European Federation of Pharmaceutical Industries and Associations' recent meeting in London, UK (Marketletter October 29), Dr Tummavuori noted that the simplified centralized procedure has been made available to signatories to the Collaboration Agreement of Drug Regulatory Authorities in European Union Associated Countries, plus Cyprus. A recent survey of marketing approval applications made by 10 companies from this group of countries, concerning 40 products and totaling 281 applications (260 made under the simplified procedures plus 21 national applications) had found that 94% of applicants using the simplified procedure were satisfied or very satisfied with it, according to Dr Tummavuori, who is serves as a member of EFPIA's EU enlargement working party.

She told the meeting that all 10 of the CADREAC signatory countries, plus Cyprus, had used the procedure, see table below: *t Country Use of CADREAC Use of national procedure procedure ------------------------------------------------ Bulgaria 24 4 Cyprus 4 4 Czech Republic 30 Estonia 21 Hungary 28 2+2 Latvia 20 1 Lithuania 21 2 Poland 31 Romania 28 2 Slovakia 31 1 Slovenia 22 3 ------------------------------------------------ TOTAL 260 21 $t