Health Canada announces a 75 day consultation on the draft guidance: ACCELERATED REVIEW OF HUMAN DRUG SUBMISSIONS. The consultation will close July 21, 2019.
To participate start by requesting the guidance document from email@example.com
Health Canada would like to inform you that we have recently launched a consultation on one of the topics of interest to you. Opened on May 7, 2019 and will close July 21, 2019.
Health Canada is announcing a 75 day consultation on the draft Guidance: Accelerated Review of Human Drug Submissions. The consultation will be open for comment beginning May 7, 2019 and will close July 21, 2019.
Health Canada is committed to working with health partners in order to improve access to those drugs that are needed most by Canadians. Under the Regulatory Review of Drugs and Devices initiative, Health Canada has consulted on priority review pathways and health care system needs in order to make determinations about which products could be reviewed under shortened timelines. Feedback from these consultations has resulted in proposed modifications to both the Priority Review of Drug Submissions policy and the Notice of Compliance with Conditions policy and these are reflected under a new title: Draft Guidance: Accelerated Review of Human Drug Submissions.
The draft guidance applies to New Drug Submissions (NDS) or Supplement to New Drug Submissions (SNDS) in support of a prescription pharmaceutical, biologic or radiopharmaceutical drug product for human use for serious, life-threatening or severely debilitating diseases or conditions. Certain elements of the guidance are also applicable to generic pharmaceuticals where the innovator product has a conditional authorization.
Health Canada is seeking your feedback on the overall clarity and content of the draft guidance. In addition, it is important we hear your views on the following proposed elements which are outlined in detail in the draft guidance:
- the single pathway for accelerated review
- two different options for screening processes
- the eligibility criteria for drug product submissions seeking an accelerated review status
How to participate
To request the guidance document please email firstname.lastname@example.org
You will receive:
- The draft guidance document, and
- The form for your comments, by section number and line number.
Please email your comments to email@example.com using the form provided. All comments will be considered in the finalization of the guidance. The 75 day consultation period is from May 7, 2019 to July 21, 2019, inclusive.
Comments can also be mailed to:Regulatory Review of Drugs and Devices
Health Products and Food Branch
100 Eglantine Driveway, Room 3303
Publication of Canada’s regulatory approach to drugs for rare diseases: orphan drugs | Publication de l’approche du Canada en matière de réglementation des médicaments utilisés pour soigner les maladies rares : les médicaments orphelins
Health Canada is pleased to announce the publication of Canada’s regulatory approach to drugs for rare disease: orphan drugs on Canada.ca: https://www.canada.ca/en/health-canada/services/licences-authorizations-registrations-drug-health-products/regulatory-approach-drugs-rare-diseases.html
This new landing page provides sponsors and interested stakeholders with open and transparent support to navigate the regulatory process in Canada for orphan drugs. Stakeholder enquiries regarding orphan drugs and the role of the regulator in Canada are answered through information provided on this webpage. Sponsors of orphan drugs can now easily access information about the various submission pathways and tools for clinical trials or a new drug submission.
Office of Policy and International Collaboration
Biologics and Genetic Therapies Directorate
Health Products and Food Branch
Building #6, 100 Eglantine Driveway
Ottawa, ON K1A 0K9
Address Locator: 0601B
Fax number: (613) 952-5364
Santé Canada a le plaisir d’annoncer la publication l’Approche du Canada en matière de réglementation des médicaments utilisés pour soigner les maladies rares : les médicaments orphelins sur Canada.ca: https://www.canada.ca/fr/sante-canada/services/licences-autorisation-et-enregistrement-medicaments-et-produits-sante/approche-canada-reglementation-medicaments-maladies-rares.html
Cette nouvelle page d’accueil offre aux promoteurs et intervenants intéressés un soutien ouvert et transparent pour naviguer le processus de réglementation des médicaments orphelins au Canada. Les demandes de renseignements des intervenants sur les médicaments orphelins et le rôle de l’autorité de réglementation compétente au Canada sont répondues par les informations fournies sur cette page web. Les promoteurs des médicaments orphelins peuvent accéder facilement à l’information sur les différentes voies de soumission et les outils pour les essais cliniques, ou une présentation de drogue nouvelle.
Bureau de la politique et de la collaboration internationale
Direction des produits biologiques et des thérapies génétiques
Direction générale des produits de santé et des aliments
Indice de l’adresse 0601B
100, promenade Eglantine, pré Tunney
Ottawa, ON K1A 0K9
Indice de l’adresse : 0601B
Télécopieur : (613) 952-5364
Health Canada-FDA Joint Public Consultation on International Council for Harmonisation (ICH) Guidelines. October 17, 2018. Attend in person in Ottawa or by webcast.
The Canada-United States (U.S.) Regulatory Cooperation Council (RCC) was created in February 2011 to better align the two countries’ regulatory approaches, where possible.
Under the RCC initiative, Health Canada and the U.S. Food and Drug Administration (FDA) are holding joint public consultation meetings on International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines currently under development. The aim of this initiative is to hold public consultation meetings prior to each bi-annual ICH face-to-face meeting, in order to seek input on areas where harmonised ICH guidelines would be beneficial. Stakeholder input received through this initiative will be considered in current or future guideline development. Health Canada also intends to use these opportunities to better understand areas in drug product regulation where Canadian requirements may differ from those in place in the U.S., with a view to minimizing these differences.
The next ICH face-to-face meeting will take place from November 10-15, 2018 in Charlotte, North Carolina, USA. In preparation for this meeting, a public consultation for Canadian and U.S. stakeholders under the RCC initiative will take place on October 17, 2018 from 9:00 AM until 12:00 PM at the Sir Frederick G. Banting Research Centre, 251 Sir Frederick Banting Driveway, Ottawa, Ontario. Stakeholders will also be able to participate by webcast (information to follow). Registration is to be completed online.
Future consultations will continue to alternate between Canada and the U.S. with the next meeting (to be hosted by the U.S. FDA in the Spring of 2019 prior to the ICH meeting which will be held in June 2019).
A draft agenda follows. For additional information including Concept Papers and any available draft guidelines for comment please visit the ICH website.
In advance of the public meeting on October 17, 2018, Health Canada and the U.S. FDA are also offering the opportunity for stakeholders to submit comments in writing. Comments will be accepted from the date of this Notice until October 14, 2018.
Please submit comments to the following email address: HPFB_ICH_DGPSA@hc-sc.gc.ca
Draft Agenda – Health Canada – U.S. FDA ICH Consultation
October 17, 2018 – 9:00AM – 12:00PM
- Opening Remarks/Introductions
- Overview of the ICH Process
- Overview of MedDRA and MedDRA Points to Consider
- Overview of Current Efficacy Topics
- Overview of Current Safety Topics
- Overview of Current Quality Topics
- Overview of Current Electronic Standards Topics
- Closing Remarks
Help shape palliative care in Canada – NEW discussion topic: Special Populations / Influencez l’avenir des soins palliatifs au Canada – NOUVEAU sujet de discussion : Populations particulières
French text follows
Health Canada is holding online public consultations on palliative care in Canada. This consultation is the first step in developing a national framework for palliative care. This is your chance to help shape palliative care in Canada.
The special populations topic for Health Canada’s online public consultations to inform the development of a national framework for palliative care is now open for discussion. Please take a few minutes to log in and share your thoughts on the following sections confidentially:
Special populations include: Indigenous people, immigrants and refugees, children, adolescents and young adults, people with disabilities, LGBTQ2 and others.
We recently posted a comment in section 4.2 Increasing Access. It would be greatly appreciated if you would “like” and hit reply to share your thoughts.
Share your stories, helpful tools, ideas. Your participation shows government that palliative care is a priority to Canadians.
Please share this invitation with your colleagues, friends and families and encourage them to participate.
As always, we appreciate your partnership and support.
Marissa Ambalina, BCom (Hons)
Santé Canada vous invite à participer à une consultation publique en ligne sur les soins palliatifs au Canada. Cette consultation constitue la première étape de l’élaboration d’un cadre pour les soins palliatifs. Voici votre chance d’influencer l’avenir des soins palliatifs au Canada.
Le thème « Populations particulières » est maintenant ouvert à la discussion dans le cadre des consultations publiques en ligne de Santé Canada en vue de l’élaboration d’un cadre national pour les soins palliatifs. Nous vous invitons à prendre quelques minutes pour vous connecter et vous exprimer sur les sujets suivants en toute confidentialité :
- 4.1 : Populations particulières – Sensibilisation
Populations particulières s’entend de plusieurs groupes, dont les peuples autochtones, les immigrants et les réfugiés, les enfants, les adolescents, les jeunes adultes, les personnes ayant des déficiences et les LGBTQ2.
Nous venons de publier un commentaire dans la section 4.2 – Amélioration de l’accès. Nous vous saurions gré de bien vouloir « aimer » ce commentaire et y répondre pour partager vos idées.
C’est le bon moment de partager vos histoires, de faire connaître des outils et d’exposer vos idées. Votre participation montrera au gouvernement que les soins palliatifs sont une priorité pour les Canadiens.
N’hésitez pas à transmettre cette invitation à vos collègues ainsi qu’à vos proches et amis pour les encourager à participer.
Comme toujours, nous vous remercions de votre collaboration et de votre soutien.
Marissa Ambalina, BCom (Hons)
JAN 5 2018: Deadline Extended – TCPS 2 Consultation | Date limite reportée – Consultation sur l’EPTC 2
On October 2017, the Panel on Research Ethics launched a period of public comment on a set of proposed changes to the second edition of the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans – TCPS 2 (2014).
This set of changes pertains to research involving human cells and cell lines.
The deadline for receipt of comments has been extended to January 5, 2018. All comments received will be posted online unless the contributor requests that they remain confidential.
Feedback received will be taken into consideration when the Panel submits recommendations to the federal research Agencies (CIHR, NSERC and SSHRC) that are responsible for approving revisions to the Policy.
Date limite reportée – EPTC 2 : Révisions proposées concernant la recherche avec des cellules et des lignées cellulaires humaines
Le 17 octobre 2017, le Groupe en éthique de la recherche (GER) a entamé une période de commentaires publics sur un ensemble de changements proposés à la deuxième édition de l’Énoncé de politique des trois Conseils : Éthique de la recherche avec des êtres humains – EPTC 2 (2014).
Cet ensemble de changements porte sur la recherche avec des cellules et des lignées cellulaires humaines.
La date limite pour la réception de commentaires a été reportée au 5 janvier 2018. Tous les commentaires reçus seront affichés en ligne, sauf les commentaires dont l’auteur demande qu’ils restent confidentiels.
Les commentaires reçus seront pris en considération lorsque le GER présentera des recommandations aux organismes de recherche fédéraux (CRSH, CRSNG et IRSC) qui ont à approuver les révisions à la Politique.
Public Comments on the Proposed Changes to TCPS 2 ( 2014)
In October 2016, the Panel on Research Ethics released proposed changes to TCPS 2 (2014) to the public for comment. Written comments were accepted until January 31, 2017. All comments received have been posted to the Panel’s website unless the contributor requested that they remain confidential.
This valuable feedback will now be taken into consideration as the Panel and Secretariat prepare recommendations to the federal research Agencies (CIHR, NSERC and SSHRC) that are responsible for approving revisions to TCPS 2 (2014).
Release of CCTCC REB Accreditation WG Final Recommendations & Joint Response by CCTCC & Health Canada
The purpose of this message is to introduce the CCTCC REB Accreditation WG’s Final Recommendations (FRs), and the joint response by the CCTCC and Health Canada (HC) to the FRs.
The full package is available HERE.
CCTCC REB WG FRs:
There are seven FRs in total, aimed at ensuring Canada’s REB competitiveness on a global scale. FR#7, which calls for the establishment of a National Strategic Leadership Forum, is seen as the foundation of the other FRs. The FRs are based on data collected through interviews with key stakeholders in the Canadian and US REB fields as well as consultations and feedback provided by key REB stakeholders in Canada.
The CCTCC REB Accreditation WG was established in 2015, in collaboration with Health Canada, to identify strategies to improve efficiencies of ethics reviews and advance strategic issues like accreditation in regards to clinical trials. The establishment of the WG is consistent with Recommendation #4 of the Action Plant to Help Attract More Clinical Trials to Canada as well as Recommendation #3 of the Senate Report entitled “Canada’s Clinical Trials Infrastructure: A prescription for Improved Access to New Medicines”.
Given the REB centralization and harmonization initiatives that have been taking place across Canada, the WG, as stated in their Interim Report (IR), did not see formal accreditation scheme as a given. The IR’s key recommendations called for investigating the:
- impact of these provincial initiatives
- models of review being adopted by these initiatives,
- standards and metrics currently being applied to REB operations (in Canada and USA)
The WG proceed with addressing the IR’s recommendations which resulted in the presented/attached FRs.
The contents of the full package include:
- Summary of the FRs and joint response by CCTCC and HC
- Full text of the FRs
- SPOR SHRER Report Committee recommendations – in fulfillment of FR I
CCTCC and Health Canada wish to express their profound gratitude to the members of the REB Accreditation Working Group (WG) and specifically the chair of the WG – Laurel Evans and the co-chair Karine Morine for their continued dedication and invaluable efforts in making the attached report a reality.
Please direct any questions to Elena Aminkova, Interim Director of Project Facilitation, CCTCC by emailing firstname.lastname@example.org
As part of Health Canada’s (HC) commitment to regulatory transparency, information on all clinical trial inspections performed in Canada will be published by December 11, 2015 in Health Canada’s existing Drug and Health Product Inspections Database.
The database will include three main elements:
Lists of Inspections
- A list of all Good Clinical Practices inspections conducted since January 1, 2012 to present will be included within the database. The list includes general information such as sponsor name, date of inspection and rating.
Initial Inspection Deficiencies
- The Initial Inspection Deficiencies provide a preliminary overview of the inspection findings and are published within 3 days of the inspection. Initial Inspection Deficiencies will be published for all inspections which occur after the launch of Good Clinical Practice inspections in the database.
Inspection Report Cards: The Inspection Report Cards offer plain language summaries of inspections. They are published within 30 days of the inspection and will include the following:
- information identifying the sponsor and drug name
- date of the inspection
- trial phase
- region of the site inspected
- inspection type
- inspection rating
- observations made by the inspector
- measures taken by Health Canada.
Inspection Report Cards will be published for all inspections conducted on or after September 15, 2015.
Inspection Report Cards will be published for any inspection conducted between January 1, 2012 and September 15, 2015 that received a non-compliant rating.
If you have inquiries about this initiative, please contact Health Canada at the following e-mail address: email@example.com
Further information about Health Canada’s Regulatory Transparency and Openness Framework can be found here.
Health Canada is requesting feedback from healthcare professionals, patients/family, researchers, pharmacists, data managers, and the general public regarding how therapeutic product information is disseminated as part of Bill C-17.
Bill C-17 introduced new transparency measures for therapeutic products, including:
- an obligation on therapeutic product authorization holders to make required information about their clinical trials publicly available on a website;
- an obligation on the Minister of Health to make publicly available all orders issued with respect to therapeutic products and positive and negative regulatory decisions; and,
- an authority for the Minister of Health to disclose confidential business information in certain circumstances.