EMA releases policy on document access
The European Medicines Agency released a new policy that will make all agency documents available upon request, including marketing authorization dossiers submitted by companies. Documents will only be available after the completion of the relevant agency procedure, such as the agency's approval or rejection of a product or the withdrawal of an application by a company. The policy excludes EMA's preparatory documents such as internal notes and documents containing opinions for internal use. The policy, which takes effect on Wednesday, will be retroactive.
EMA issued guidance outlining the types of documents that will be available and whether they will be subject to redaction to protect commercially or personally sensitive information. EMA will initially release documents only upon request but in the future plans to proactively release them on its website. ...