Article,
Transparency in drug regulation: Mirage or oasis?
CMAJ, 171 (23): 1363 (2004)
Abstract
In Canada, the information used to approve new drugs is deemed commercially sensitive and hence confidential under the Access to Information Act,1 and the Therapeutic Products Directorate (TPD) will not release such information without the manufacturer's approval. As a consequence, safety and efficacy information contained in unpublished trials submitted to the TPD is generally unavailable to researchers, physicians and patients, a situation that can potentially lead to the inappropriate prescribing and use of medications.
