E-Submission Process Will Pare EMA Response Time on Trial Data Requests

The European Medicines Agency expects to respond more expeditiously to public requests for clinical trial data, thanks in part to newly required electronic marketing authorization applications. While information retrieval is easier than with the previous paper-based system, “electronic submission is an ongoing project which will continue to evolve,” the EMA said in response to criticisms lodged by the EU’s ombudsman.
International Pharmaceutical Regulatory Monitor