Can important therapies or drugs be obtained prior to market authorization in Canada?
The Special Access Program, administered by the TPD, allows physicians to gain access to drugs which are not currently available in Canada. Following approval by the Special Access Programme, a physician may prescribe such a drug to specified patients, if it is the physician’s belief that conventional therapies have failed or are inappropriate. The drug is only released after the TPD has determined that the need is legitimate and that a qualified physician is involved. Once a drug has been approved, how is it monitored? Once a new drug is on the market, regulatory controls continue. The distributor of the drug must report any new information received concerning serious side effects including failure of the drug to produce the desired effect. The distributor must also notify the TPD about any studies that have provided new safety information. The TPD monitors adverse events, investigates complaints and problem reports, maintains post-approval surveillance, and manages recalls, should th
