Health Canada welcomes comments on release of clinical information on drugs and medical devices
Increased transparency benefits Canadians and the health care system
OTTAWA, Dec 8, 2017 /CNW/ - Health Canada is modernizing its approach to disclosing clinical information on drugs and medical devices to support advances in medical science and help improve patient care. Today, Health Canada published draft regulations in Canada Gazette l that propose to make clinical information in drug and medical device submissions publicly available after the Department has completed its regulatory review process.
Health Canada uses clinical data when making regulatory decisions on drug and medical device submissions. These data provide comprehensive information on the safety and efficacy of these products. Increasing access to clinical data can have widespread benefits for patients and the health care system, for example:
Providing more detailed information about drugs and medical devices enables independent analysis that could help health professionals make more informed decisions about their appropriate use; and
Sharing these data could also help reduce inappropriate use of drugs and medical devices.
In considering how best to make this information more broadly available, Health Canada sought public input on a discussion paper that was published online. It is also consulting expert stakeholders, including industry representatives, academic researchers and healthcare professionals on implementation of these proposed regulations.
The draft regulations are available for public comment for a 75-day period, beginning December 9.
Quotes
"Greater access to clinical information can assist researchers and health professionals, contributing to improved patient safety and better health outcomes for Canadians." The Honourable Ginette Petitpas Taylor Minister of Health
Quick Facts
Clinical data would continue to be treated as confidential business information during Health Canada's review process, including appeal or reconsideration of a decision. It would no longer be considered confidential following the completion of the review.
Internationally, the European Medicines Agency (EMA) and the US Department of Health and Human Services (HHS) have established or introduced initiatives to share clinical information while protecting privacy and commercial interests. Health Canada's proposed approach to clinical information sharing is aligned with that of other countries, and aims to reduce current administrative burdens while protecting privacy and supporting the medical and research communities.
In addition to regulatory agency initiatives, pharmaceutical companies have also taken voluntary initiatives to provide qualified researchers with access to clinical data in order to advance medical science or improve patient care.
Alligator Bioscience (STO:ATORX)Publication in world-leading clinical oncology journal validates the quality and potential implications of Phase 2 OPTIMIZE-1 resultsThe study reported Objective Response Rate (ORR) of 40.4% in 57 evaluable patients,...
Augnito, a leading provider of multi-lingual speech recognition, generative AI, and natural language processing technology, is pleased to announce the appointment of Hamza Moftah as Associate Vice President of Sales. In this role, Hamza will leverage...
Thermo Fisher Scientific Inc., the world leader in serving science, has opened a new clinical and commercial ultra-cold facility in the EU, expanding its clinical trial network in Europe to help accelerate the development of advanced therapies. The...
Regulatory News:
GenSight Biologics (Euronext: SIGHT, ISIN: FR0013183985, PEA-PME eligible) (Paris:SIGHT), a biopharma company focused on developing and commercializing innovative gene therapies for retinal neurodegenerative diseases and central...
Avanzanite Bioscience B.V. ("Avanzanite" or the "Company"), a commercial-stage specialty pharmaceutical company, solely focused on medicines for rare diseases, announced today that the European Medicines Agency's ("EMA") Committee for Medicinal...
Formosa Laboratories, Inc., a leading API supplier and CDMO headquartered in Taiwan, has successfully completed its acquisition of SynChem, Inc., a contract research laboratory located in suburban Chicago. SynChem will now operate under the new name...