Notice of Decision/Summary Basis of Decision Evaluation

Introduction

Background: Summary Basis of Decision Initiative

Transparency is a fundamental good regulatory practice and a clear expectation of the Canadian public. Health Canada is committed to enhancing the transparency of the regulatory review process for drugs and medical devices. The Summary Basis of Decision initiative was developed in 2004 in demonstration of this commitment to transparency. As part of the Summary Basis of Decision initiative, Health Canada publishes Notice of Decision and Summary Basis of Decision documents.

In the past, Canadian healthcare professionals frequently relied on foreign approval packages to obtain information about drugs and medical devices as there was no similar information disseminated in Canada. These foreign information sources may be inconsistent with Canadian regulatory decisions and may not provide information appropriate to the Canadian context. As a result of significant efforts to make drug and medical device product information available, including the Summary Basis of Decision and Product Monograph web-posting initiatives, Canadian healthcare professionals and patients have more information at their disposal to support informed treatment choices.

The Notice of Decision is an approximately one-page summary outlining the authorization received and general information related to the drug or medical device. The Notice of Decision is published independently after product authorization and is incorporated into the Summary Basis of Decision document as Section 2.

The Summary Basis of Decision document outlines the scientific and benefit/risk-based considerations that factored into Health Canada's decision to grant market authorization for a drug or medical device. The document includes regulatory, safety, efficacy, and quality (chemistry and manufacturing) considerations and reflects the information within the regulatory review reports.

Notices of Decision and Summary Basis of Decision documents are written for those interested in the basis for Health Canada's product-specific decisions for drugs and medical devices. The documents are drafted in technical language with accompanying reader's guides and background documentation. They are intended to complement information from documents written in lay language and directed to the general public, such as the Operator's Manual or Package Insert (for medical devices), and the Product Monograph Part III: Consumer Information (for drugs). In addition, the Operator's Manual (and/or Package Insert) (for devices) or the Product Monograph Part III (for drugs) that was approved when the product was first authorized is also posted on the Health Canada Web site along with the Summary Basis of Decision document.

The Summary Basis of Decision initiative is being implemented in a phased approach and began with new drug submissions for new active substances and a subset of Class IV medical device applications authorized after January 1, 2005. Between January 1, 2005 and September 30, 2008, 104 Notices of Decision (61 for pharmaceuticals, 24 for biologics, and 19 for medical devices) and 93 Summary Basis of Decision documents (51 for pharmaceuticals, 22 for biologics, and 20 for medical devices) were published.

To see examples of published Notices of Decision and Summary Basis of Decision document for drugs and medical devices, refer to the Summary Basis of Decision section of the Health Canada Web site.

Notice of Decision and Summary Basis of Decision documents are supported by Readers' Guides (for drugs and medical devices) posted on the Summary Basis of Decision section of the Health Canada Web site in the Communications section.

In addition to the Summary Basis of Decision initiative, information about the risks and benefits of drugs authorized after January 2004 can be found in Health Canada-authorized Product Monographs, available on the Health Canada Web site. A Product Monograph is a factual, scientific document on a drug product that, devoid of promotional material, describes the properties, claims, indications (uses) and conditions of use for the drug and any other information that may be required for optimal, safe and effective use of the drug. Full Product Monographs are available through the Drug Product Database.

Evaluation of Phase I of the Summary Basis of Decision Initiative

Health Canada is undertaking an evaluation of phase I of the Summary Basis of Decision initiative. As part of this evaluation, we are asking stakeholders to complete this workbook and submit it to OBT_enquiries@hc-sc.gc.ca by May 15, 2009.

The intent of the workbook is to evaluate external stakeholders' satisfaction with Notice of Decision and Summary Basis of Decision documents and with the Summary Basis of Decision initiative in general.

Other components of the evaluation of phase I include:

• Surveys distributed to a range of Health Canada staff to evaluate internal satisfaction with the documents and the initiative, and interviews to collect more in-depth information.
• A questionnaire distributed to drug submission sponsors and medical device manufacturers whose products were the subject of a Notice of Decision or Summary Basis of Decision document published prior to October 1, 2008. The questionnaire assessed their involvement in the process to post the documents on the Health Canada Web site.

The results of the evaluation of phase I of the Summary Basis of Decision initiative will be published on the Health Canada Web site in summer/fall 2009.

Following the evaluation of phase I, Health Canada will examine the development of phase II of the Summary Basis of Decision initiative. Proposals for phase II will be based, in part, on what Health Canada learns through the internal and external evaluation of phase I, and will be subject to full internal and external consultations prior to implementation. For more information, consult the Summary Basis of Decision section of the Health Canada Web site.

Workbook questions

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Section 1. Knowledge of Notice of Decision and Summary Basis of Decision Documents

Question 1

1. How did you find out about Notice of Decision or Summary Basis of Decision documents?
a. I found them while searching for information about a drug or medical device
b. I followed a link from another page on the Health Canada Web site
c. I was told about them by my healthcare professional (doctor, pharmacist, nurse, etc.)
d. I was involved in the June 2004 Summary Basis of Decision consultative workshop held Health Canada
e. I am involved with Notice of Decision or Summary Basis of Decision production
f. Other (please specify)

Section 2. Notice of Decision Documents

Notices of Decision are concise documents that precede the publication of the Summary Basis of Decision for a product. They typically contain general information about the product and the authorization received.

Notices of Decision for drugs describe the authorization, the medicinal ingredient(s) and class of drug, the indication(s), and the basis for the market authorization. The document also briefly outlines the dosing instructions and contraindications.

Notices of Decision for medical devices describe the authorization, the medical device, the indication and contraindications. The document also briefly outlines the basis for the market authorization.

To see examples of Notices of Decision for drugs and medical devices, refer to the Summary Basis of Decision section of the Health Canada Web site.

Question 2

2. How many Notices of Decision have you read in the past six months?
a. 0 (go to question 4)
b. 1-2
c. 3-5
d. 6-8
e. 9-10
f. 11+

Question 3

3. What was the reason you read a Notice of Decision? (Check all that apply)
a. I wanted information about a particular drug or medical device
b. I wanted information about the drug or medical device review process in Canada
c. I am interested in Health Canada transparency initiatives
d. I am involved with Notice of Decision or Summary Basis of Decision production
e. Other (please specify)

Question 4

4. Does the Notice of Decision provide useful information about the product and/or the submission?
a. Yes
b. No
c. Somewhat
d. I don't know

Please explain your answer

Question 5

5. Are you able to understand the language used in a Notice of Decision?
a. Yes
b. No
c. Somewhat
d. I don't know

Please explain your answer

Question 6

6. Are Notices of Decision available in a timely manner after drug or medical device authorization?
a. Yes, they are available in an appropriate amount of time
b. No, they should be available sooner
c. I don't know

Please explain your answer

2.1 Content of Notices of Decision

Question 7

7. What (if any) additional information should be included in a Notice of Decision?

Question 8

8. What (if any) information should be removed from a Notice of Decision?

Question 9

9. Would you like to make any other comments about the content of the Notice of Decision document?

Section 3. Summary Basis of Decision Documents

A Summary Basis of Decision document outlines the scientific and benefit/risk-based considerations that factored into Health Canada's decision to grant market authorization for a drug or medical device. The document includes regulatory, safety, efficacy, and quality (chemistry and manufacturing) considerations.

Question 10

10. How many Summary Basis of Decision documents have you read in the past six months?
a. 0 (go to question 12)
b. 1-2
c. 3-5
d. 6-8
e. 9-10
f. 11+

Question 11

11. What was the reason you read a Summary Basis of Decision? (Check all that apply)
a. I wanted information about a particular drug or medical device
b. I wanted information about the drug or medical device review process in Canada
c. I am interested in Health Canada transparency initiatives
d. I am involved with Notice of Decision or Summary Basis of Decision production
e. Other (please specify)

Question 12

12. Does the Summary Basis of Decision provide useful information about the product, the drug submission and/or the medical device application?
a. Yes
b. No
c. Somewhat
d. I don't know

Please explain your answer

Question 13

13. Does the Summary Basis of Decision provide useful information about the drug or medical device review process in Canada?
a. Yes
b. No
c. Somewhat
d. I don't know

Please explain your answer

Question 14

14. Does the Summary Basis of Decision help you make informed treatment choices, either for yourself or for your patients?
a. Yes
b. No
c. Somewhat
d. I don't know

Please explain your answer

Question 15

15. Are you able to understand the language used in a Summary Basis of Decision?
a. Yes
b. No
c. Somewhat
d. I don't know

Please explain your answer

Question 16

16. Are Summary Basis of Decision documents available in a timely manner after drug or medical device authorization?
a. Yes, they are available in an appropriate amount of time
b. No, they should be available sooner
c. I don't know

Please explain your answer

3.1 Content of Summary Basis of Decision Documents

3.1.1 Summary Basis of Decision Documents for Drugs

Summary Basis of Decision documents for drugs (pharmaceuticals and biologics) include the following information:

Section 1. Product and Submission Information

Section 2. Notice of Decision

Section 3. Scientific and Regulatory Basis for Decision

3.1 Quality Basis for Decision

3.1.1 Drug Substance (Medicinal Ingredient)
3.1.2 Drug Product
3.1.3 Facilities and Equipment
3.1.4 Adventitious Agents Safety Evaluation
3.1.5 Conclusion

3.2 Non-clinical Basis for Decision

3.2.1 Pharmacodynamics
3.2.2 Pharmacokinetics
3.2.3 Toxicology
3.2.4 Summary and Conclusion

3.3 Clinical Basis for Decision

3.3.1 Human Pharmacology
3.3.2 Pharmacodynamics
3.3.3 Pharmacokinetics
3.3.4 Clinical Efficacy
3.3.5 Clinical Safety
3.3.6 Additional Issues

3.4 Benefit/Risk Assessment and Recommendation

3.4.1 Benefit/Risk Assessment
3.4.2 Recommendation

Section 4. Submission Milestones

To see examples of Summary Basis of Decision documents for drugs, refer to the Summary Basis of Decision section of the Health Canada Web site.

Question 17

17. Which section(s) of a Summary Basis of Decision document for a drug is (are) the most useful, and why?

Question 18

18. What (if any) information should be added to a Summary Basis of Decision document for a drug, and why?

Question 19

19. What (if any) information should be removed from a Summary Basis of Decision document for a drug, and why?

Question 20

20. The Summary Basis of Decision documents for drugs are posted with the Product Monograph Part III: Consumer Information that was approved when the product was first authorized. Now that full Product Monographs are available on the Health Canada Web site, is there benefit to posting Part III of the Product Monograph alongside the Summary Basis of Decision?
a. Yes
b. No
c. I don't know

Please explain your answer

Question 21

21. Is there any additional information that should accompany the Notice of Decision and Summary Basis of Decision posting for a drug?
a. Yes (Please specify)
b. No
c. I don't know

Question 22

22. Would you like to make any other comments about the Summary Basis of Decision document for drugs?

3.1.2 Summary Basis of Decision Documents for Medical Devices

Summary Basis of Decision documents for medical devices include the following information:

Section 1. Device and Application Information

Section 2. Notice of Decision

Section 3. Scientific and Regulatory Basis for Decision

3.1 Introduction

3.2 Device-Specific Detailed Information

3.3 Devices Containing Biological Material

3.4 Safety and Effectiveness

3.4.1 List of Standards
3.4.2 Method of Sterilization
3.4.3 Manufacturing and Quality Control
3.4.4 Preclinical Studies
3.4.5 Clinical Effectiveness and Safety
3.4.6 Software Validation Studies
3.4.7 Labelling

3.5 Risk/Benefit Assessment

3.6 Recommendation

Section 4. Application Milestones

To see examples of Summary Basis of Decision documents for medical devices, refer to the Summary Basis of Decision section of the Health Canada Web site.

Question 23

23. Which section(s) of a Summary Basis of Decision document for a medical device is (are) the most useful, and why?

Question 24

24. What (if any) information should be added to a Summary Basis of Decision document for a medical device, and why?

Question 25

25. What (if any) information should be removed from a Summary Basis of Decision document for a medical device, and why?

Question 26

26. The Summary Basis of Decision documents for medical devices are posted with the Operator's Manual and/or Package Insert that was approved when the product was first authorized. Is there benefit to posting this information alongside the Summary Basis of Decision?
a. Yes
b. No
c. I don't know

Please explain your answer

Question 27

27. Is there any additional information that should accompany the Notice of Decision and Summary Basis of Decision posting for a medical device?
a. Yes (Please specify)
b. No
c. I don't know

Question 28

28. Would you like to make any other comments about the Summary Basis of Decision document for medical devices?

Section 4. Scope of Phase I of the Summary Basis of Decision Initiative

Currently, as part of phase I of the Summary Basis of Decision initiative, Notice of Decision and Summary Basis of Decision documents are prepared for the following:

• new drug submissions for new active substances that received a Notice of Compliance after January 1, 2005; and
• new Class IV medical device applications that received a licence after January 1, 2005, related to any of the following: priority review applications, in vitro diagnostic devices for donor screening, cardiovascular devices with novel technology (endovascular stenting systems, carotid stenting systems, and left ventricular assist devices) and new indications for use for cardiovascular and neurological devices.

Question 29

29. The list of submissions and applications for which Notices of Decision are drafted is:
a. Too small - additional types of submissions or applications should receive a Notice of Decision
b. Too large - some types of submissions or applications should be removed from the list (go to question 31)
c. Satisfactory as it currently stands (go to question 32)

Question 30

30. What additional type(s) of submissions or applications should receive a Notice of Decision?

Question 31

31. What type(s) of submissions or applications should be removed from the list? (i.e. should not receive a Notice of Decision)

Question 32

32. The list of submissions and applications for which Summary Basis of Decision documents are drafted is:
a. Too small - additional types of submissions or applications should receive a Summary Basis of Decision document
b. Too large - some types of submissions or applications should be removed from the list (go to question 34)
c. Satisfactory as it currently stands (go to question 35)

Question 33

33. What additional type(s) of submissions or applications should receive a Summary Basis of Decision document?

Question 34

34. What type(s) of submissions or applications should be removed from the list? (i.e. should not receive a Summary Basis of Decision document)

Notice of Decision and Summary Basis of Decision documents are currently drafted for the first authorization only; the documents are never updated to include post-authorization activity.

Question 35

35. Do you agree with this approach?
a. Yes (go to question 37)
b. No
c. I don't know

Please explain your answer

Question 36

36. When should Notices of Decision and Summary Basis of Decision documents be updated? (Check all that apply)
a. As additional submissions or applications for a product are authorized
b. As additional submissions or applications for a product are rejected
c. As conditions of authorization are met or removed
d. On a regular schedule, to include all activity related to that product within that time
e. Other (please specify)

Question 37

37. Would you like to make any other comments about the scope of phase I of the Summary Basis of Decision initiative?

Section 5. Background/Supporting Information for Notice of Decision and Summary Basis of Decision Documents

The Notice of Decision and Summary Basis of Decision documents are supported by Readers' Guides (for drugs and medical devices) posted on the Summary Basis of Decision section of the Health Canada Web site in the Communications section.

Question 38

38. Have you read the Readers' Guides?
a. Yes (Please specify drugs or medical devices or both)
b. No (go to question 40)

Question 39

39. Do you find the Readers' Guides useful?
a. Yes
b. No
c. Somewhat
d. I don't know

Please explain your answer

Question 40

40. What additional information would help your understanding or use of Notice of Decision or Summary Basis of Decision documents?

Question 41

41. Would you like to make any other comments about the background/supporting information for the Summary Basis of Decision initiative?

Section 6. Accessibility of documents

Question 42

42. How easily are you able to access Notice of Decision and Summary Basis of Decision documents on the Health Canada Web site?
a. They are easy to find
b. I can find them, but only through a search engine
c. They are difficult to find
d. I have never looked for them

Question 43

43. Would you like to make any other comments about Notice of Decision or Summary Basis of Decision documents, or the Summary Basis of Decision initiative?

Section 7. About You

Question 44

44. The category that best describes your perspective is:
a. Federal government official
b. Provincial government official
c. Drug submission sponsor
d. Medical device manufacturer
e. Patient
f. Healthcare professional
g. Public interest group
h. Concerned citizen
i. Academic/researcher
j. Other (please specify)