Canada Accepts Clinical Trial Result From Outside
Nov 15, 2015 14:12:51 GMT -5
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Post by lakers on Nov 15, 2015 14:12:51 GMT -5
What are the steps in the review process for a drug?
When a sponsor decides that it would like to market a drug in Canada, it files a "New Drug Submission" with HPFB. This contains information and data about the drug's safety, effectiveness and quality. It includes the results of the preclinical and clinical studies, whether done in Canada or elsewhere, details regarding the production of the drug, packaging and labelling details, and information regarding therapeutic claims and side effects.
HPFB performs a thorough review of the submitted information, sometimes using external consultants and advisory committees.
HPFB evaluates the safety, efficacy and quality data to assess the potential benefits and risks of the drug.
HPFB reviews the information that the sponsor proposes to provide to health care practitioners and consumers about the drug (e.g. the label, product brochure).
If, at the completion of the review, the conclusion is that the benefits outweigh the risks and that the risks can be mitigated, the drug is issued a Notice of Compliance (NOC), as well as a Drug Identification Number (DIN) which permits the sponsor to market the drug in Canada and indicates the drug's official approval in Canada.
In addition, Health Canada laboratories may test certain biological products before and after authorization to sell in Canada has been issued. This is done through its Lot Release Process, in order to monitor safety, efficacy and quality.
www.hc-sc.gc.ca/dhp-mps/prodpharma/activit/fs-fi/reviewfs_examenfd-eng.php
How long does the drug review process take?
HPFB has set internationally competitive performance targets for its conduct of reviews. The length of time for review depends on the product being submitted and the size and quality of the submission, and is influenced by HPFB's workload and human resources.
Are some drugs reviewed more quickly?
HPFB has a Priority Review Process in place which allows for a faster review to make available promising drug products for life-threatening or severely debilitating conditions, such as cancer, AIDS, or Parkinson's Disease, for which there are few effective therapies already on the market.
Can important therapies or drugs be obtained prior to market authorization in Canada?
The Special Access Program, administered by HPFB, 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 HPFB has determined that the need is legitimate and that a qualified physician is involved. The drug's manufacturer must also agree to release the product to the qualified physician.
When a sponsor decides that it would like to market a drug in Canada, it files a "New Drug Submission" with HPFB. This contains information and data about the drug's safety, effectiveness and quality. It includes the results of the preclinical and clinical studies, whether done in Canada or elsewhere, details regarding the production of the drug, packaging and labelling details, and information regarding therapeutic claims and side effects.
HPFB performs a thorough review of the submitted information, sometimes using external consultants and advisory committees.
HPFB evaluates the safety, efficacy and quality data to assess the potential benefits and risks of the drug.
HPFB reviews the information that the sponsor proposes to provide to health care practitioners and consumers about the drug (e.g. the label, product brochure).
If, at the completion of the review, the conclusion is that the benefits outweigh the risks and that the risks can be mitigated, the drug is issued a Notice of Compliance (NOC), as well as a Drug Identification Number (DIN) which permits the sponsor to market the drug in Canada and indicates the drug's official approval in Canada.
In addition, Health Canada laboratories may test certain biological products before and after authorization to sell in Canada has been issued. This is done through its Lot Release Process, in order to monitor safety, efficacy and quality.
www.hc-sc.gc.ca/dhp-mps/prodpharma/activit/fs-fi/reviewfs_examenfd-eng.php
How long does the drug review process take?
HPFB has set internationally competitive performance targets for its conduct of reviews. The length of time for review depends on the product being submitted and the size and quality of the submission, and is influenced by HPFB's workload and human resources.
Are some drugs reviewed more quickly?
HPFB has a Priority Review Process in place which allows for a faster review to make available promising drug products for life-threatening or severely debilitating conditions, such as cancer, AIDS, or Parkinson's Disease, for which there are few effective therapies already on the market.
Can important therapies or drugs be obtained prior to market authorization in Canada?
The Special Access Program, administered by HPFB, 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 HPFB has determined that the need is legitimate and that a qualified physician is involved. The drug's manufacturer must also agree to release the product to the qualified physician.
