EU rules close research and development/generic gap
Research-based and generic pesticide companies are becoming less distinct as they face similar regulatory requirements under the EU agrochemical registration Directive (91/414). Terry Tooby, regulatory affairs director at UK consultancy JSC International, observed the trend at the AgChem Forum conference in September in Berlin, Germany. Most applications for EU approval of off-patent products now come from generic companies, Mr Tooby said. "With mergers and acquisitions, industry structure has changed dramatically," Mr Tooby pointed out. Such changes and the need to meet strict registration requirements means that the distinction between generics and R&D companies is becoming less well defined, he said.