Capra.ca

Biosimilars and their Approval in Canada

WebPublished on March 24, 2022. BIOSIMILARS AND THEIR APPROVAL IN CANADA. Biosimilars are regulated as innovative pharmaceuticals in Canada under Food and …

Actived: 6 days ago

URL: https://capra.ca/en/blog/biosimilars-and-their-approval-in-canada-2022-03-22

Health Canada’s Proposal for Clinical Trials Regulatory

WebPublished on July 16, 2021. On May 20, 2021 Health Canada opened a consultation on its proposal to modernize the regulatory framework for clinical trials related to human drugs, …

Category: Health Go Health

Clinical Trial Regulatory Activities in eCTD

WebAuthor: Preetha Prabhu. On February 19, 2020, Health Canada announced that the pilot for Clinical Trial regulatory activities in electronic Common Technical …

Category: Health Go Health

Post-NOC Changes – Quality Guidance Overview and Update

WebRelaxation of an acceptance criteria (Cont’d) Principal Supporting Data Requirements: Updated specification with justification for the change. If a Schedule B standard is …

Category: Health Go Health

Digital Therapeutics

WebAdvantages of Digital Therapeutics in today’s world: DTx products can help patients, healthcare professionals and payors in the following ways (2). Patients. Improve …

Category: Health Go Health

Canadian Product Monograph– Upcoming changes

WebIn April 2019, Health Canada announced its intent to transition product monograph templates to a structured format based on XML, Health Level 7's (HL7) …

Category: Health Go Health

Overview of Revised Draft Quality Guidance for Clinical Trial

WebInformation regarding the compatibility of the container closure system (including all drug delivery components, i.e. PVC tubing for infusion kits) with the drug product should be …

Category: Health Go Health

Changes to the Manufacturer's name and/or Product Name

WebThe Policy on Changes in Manufacturer’s name and/or Product Name (CMPN) applies to drug submissions to Health Canada where the manufacturer's and/or …

Category: Health Go Health

Software as a Medical Device (SaMD): Definition and Classification

WebOn December 18, 2019 the finalization of the guidance document on Software as a Medical Device (SaMD): Definition and Classification came into effect. This guidance document …

Category: Medical Go Health

HC-HTA Alignment

WebHC and HTAs will monitor and adjust the aligned review process as needed to ensure that it provides benefits to HC, HTAs, and industry. They will also ensure the process supports …

Category: Health Go Health

Pharmacogenomics: New Directions in Regulatory Strategies

Web11 Incorporating These Exploratory Strategies into Early Clinical Development is Complex zEthical Issues on Sample Collection and Coding zHow are samples coded or …

Category: Health Go Health

Regulatory Enrolment Process: Mandatory effective October 1, …

WebOn Mar. 30, 2020, Health Canada published a notice that as of October 1, 2020 use of the Regulatory Enrolment Process (REP) will be mandatory for …

Category: Health Go Health

Canadian Drug Establishment Licences: GMP Requirements for API …

Web2. copy of the GMP certificate issued by the recognised regulatory authority, stating the outcome of the inspection above (if available); 3. corrective actions taken, …

Category: Health Go Health

Health Canada Draft Revised Guidance Documents on Post-NOC

WebOn August 6, 2021, Health Canada issued five draft revised Guidance Documents on Post-Notice of Compliance (NOC) Quality Changes for stakeholder …

Category: Health Go Health

Health Canada Regulatory and Clinical Modernization Initiatives

WebThese two virtual interactive workshops with Health Canada officials will provide attendees with information on regulatory modernization initiatives being …

Category: Health Go Health

NHP: Site Licensing Update

WebMission: Health Canada is the federal department responsible for helping the people of Canada maintain and improve their health. In May 2016 NNHPD moved to a new …

Category: Health Go Health

Plain Language Labelling (PLL) Requirements

WebC.01.004.01(1) (a), (b) , C.01.004.01(2) Intended to ensure that users are given information on drug labels that will allow them to report problems or adverse reactions, or have a …

Category: Health Go Health

Health Canada Update on Investigational Testing Authorizations …

WebInvestigational Testing Authorization (ITA) issued by Health Canada, allows for the testing of Class II, III, and IV medical devices with human subjects. For …

Category: Medical Go Health

Strategies for Filing Efficient Submissions

WebThe Cover Letter should clearly indicate the reason for the filing and relevant pre-submission correspondence with Health Canada should be referenced (as well as included in …

Category: Health Go Health

Post-NOC Level III Change Updates

WebPost-NOC Level III Change Updates. Published on January 7, 2019. Author: Karen Zhou. A post-NOC change is any change made to a new drug that has received a …

Category: Health Go Health

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