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March 11, 2004
Our Reference: 04-104259-111
NOTICE
HPFB TO PUBLISH ‘SUMMARY BASIS OF DECISION’ DOCUMENTS
Further to messages conveyed at the November 2003 Drug Information Association
(DIA) First Canadian Annual Meeting in Ottawa, Ontario, Health Canada
wishes to inform you of its intent to publish Summary Basis of Decisions
(SBD)related to drug submissions and medical device applications. The
SBD will outline the scientific and benefit/risk-based reasons for Health
Canada’s decision to grant market authorization for a product.
Transparency is a fundamental good regulatory practice and a clear expectation
of the Canadian public. Health Canada has committed to enhancing the transparency
of the regulatory review process for drugs and medical devices and accordingly
is developing Canadian SBD documents that will provide appropriate information
to Canadians about the benefits and risks of therapeutic products. As
a result, Canadian healthcare professionals and consumers will have more
information at their disposal to make informed treatment choices.
Once an SBD template is developed, Health Canada proposes a phased implementation
strategy to support the SBD initiative. Initially, the documents would
be publicly disclosed for market authorizations related to New Drug Submissions
(NDSs) for New Active Substances (NASs) and a subset of Class IV medical
device applications. The second and third phases of implementation would
encompass additional drug submission and medical device application types,
including supplemental new drug submissions and an expanded set of Class
IV device applications, respectively.
The Health Products and Food Branch (HPFB)will be hosting a spring consultative
workshop for interested parties, including patient and consumer groups,
to provide input into the proposed content, format and publication of
the SBD document.
Any comments regarding the proposed document or consultations should
be directed to Tara Bower, Policy Bureau, Therapeutic Products Directorate,
within thirty (30) days, at the coordinates below.
By Mail
1600 Scott Street,
Holland Cross, Tower 'B',
2nd Floor, Address Locator 3102C5,
Ottawa, Ontario, K1A 1B6,
By fax to 613-941-6458
By email to tara_bower@hc-sc.gc.ca
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