HEALTH CANADA PART C DIVISION 5 -DRUGS FOR CLINICAL TRIALS INVOLVING HUMAN SUBJECTS
Health Products and Food Branch
1
www.hc-sc.gc.ca
Part C - Division 5
www.hc-sc.gc.ca
2
Part A: Administration
Part B: Foods
Part C: Drugs
Part D: Vitamins, Minerals and Amino Acids
Part E: Cyclamate and Saccharin Sweeteners
Part G: Controlled Drugs
Part J: Restricted Drugs
Part C Division 5
www.hc-sc.gc.ca
3
Part C: Drugs Division 1 Drugs General/Establishment Licenses
Division 2 Good Manufacturing Practices
Division 3 Schedule C drugs (Radiopharmaceuticals)
Division 4 Schedule D drugs (Biological)
Division 5 Drugs for Clinical Trials Involving Human Subjects
Division 6 Canadian Standard Drugs
Division 7 Sale of drugs for the purposes of implementing the general council decision
Division 8 - New Drugs
Division 9 Prescription Drugs
Clinical Trials Regulatory Framework
www.hc-sc.gc.ca
4
Food and Drugs Act (FDA)
Food and Drug Regulations (FDR), Division 5
Came into force on September 1, 2001
Regulations are not applicable to Medical Devices or Natural Health Products
Integrate Good Clinical Practices
Regulatory Framework
www.hc-sc.gc.ca
5
Food and Drugs Act
Food and Drugs Regulations
Part C: Drugs
Division 5: Drugs for Clinical Trials involving Human
Subjects
Other Regulations
Key Aspects of Division 5
www.hc-sc.gc.ca
6
Introduction of a 30-day review default period for clinical trial applications
Requirement for REB approvals prior to enrolment
Integration of Good Clinical Practices (GCP)
Requirements for clinical trial sites, Qualified Investigators (QI), REBs and Sponsors
Requirement for adverse reaction reporting
Overview of Division 5
www.hc-sc.gc.ca
7
(C.05.001) Interpretation
Qualified Investigator:
The person responsible to the sponsor for the conduct of the clinical trial at a clinical trial site, who is entitled to provide health care under the laws of the province where the laws of the province where that clinical trial site is located
In the case of a clinical trial respecting a drug to be used for dental purposes only, a physician or dentist and a member in good standing of a professional medical or dental association
In any other case, a physician and a member in good standing of a professional medical association
Overview of Division 5
www.hc-sc.gc.ca
8
(C.05.001) Interpretation contd Research Ethics Board
A body that is not affiliated with the sponsor, and
The principal mandate of which is to approve the initiation of and conduct periodic reviews of, biomedical research involving human subjects
That has at least five members, that has a majority of members who are Canadian citizens or permanent residents and that includes at least
Two member whose primary experience and expertise are in a scientific discipline
One member knowledgeable in ethics
One member knowledgeable in Canadian laws
One member whose primary experience and expertise are in a nonscientific discipline
One member who is from the community
Overview of Division 5
www.hc-sc.gc.ca
9
(C.05.002) Application This Division applies to the sale or importation of drugs to be used
for the purposes of clinical trials involving human subjects
(C.05.003) Prohibition
No person shall sell or import a drug for the purposes of a clinical trial unless The person is authorized under this Division;
The person complies with this Division
If the drug is to be imported, the person has a representative in Canada who is responsible for the sale of the drug.
Overview of Division 5
www.hc-sc.gc.ca
10
(C.05.004) General
Despite these Regulations, a sponsor may submit an application under this Division to sell or import a drug for the purposes of a clinical trial that contains a substance the sale of which is prohibited by these Regulations, if the sponsor establishes, on the basis of scientific information, that the inclusion of the substance in the drug may result in the therapeutic benefit for a human being
Overview of Division 5
www.hc-sc.gc.ca
11
(C.05.005) Application for Authorization An application by a sponsor for authorization to sell or import a drug for
the purposes of a clinical trial under this Division shall be submitted to the Minister, signed and dated by the sponsors senior medical or scientific officer in Canada and senior executive officer
Overview of Division 5
www.hc-sc.gc.ca
12
(C.05.006) Authorization A sponsor may sell or import a drug for the purposes of a clinical
trial if: The sponsor has submitted an application
Health Canada has not objected to the conduct of the study (30 days default period)
For each clinical trial site
REB approval has been obtained
Information is submitted about the QI, the REB that granted approval and any that refused to approve the study, as well as the proposed date for the commencement of the trial
Overview of Division 5
www.hc-sc.gc.ca
13
(C.05.007) Notification
The sponsor may make the following changes:
A change to the chemistry and manufacturing information that does not affect the quality or safety of the drug, other than a change for which an amendment is required by section C.05.008 and
A change to the protocol that does not alter the risk to the health of a clinical trial subject, other than a change for which an amendment is required by section C.05.008
The sponsor must notify Health Canada within 15 days after the date of the change
Overview of Division 5
www.hc-sc.gc.ca
14
(C.05.008) Amendment The sponsor may sell or import the drug for the purposes of
the clinical trial in accordance with the amended authorization if:
The sponsor has submitted an application for amendment
Health Canada has not objected (30 day default period)
Each clinical trial site:
Information is submitted about the REB that granted approval for the amendment and any that refused to approve the amended study
Any changes to the commencement date and/or the QI information are documented
The sponsor ceases to sell or import the drug in accordance with the existing authorization
Overview of Division 5
www.hc-sc.gc.ca
15
(C.05.009) Additional Information and Samples The sponsor may be required to submit, within two days after receipt
of the request, samples of the drug or additional information relevant to the drug or the clinical trial that are necessary to make the determination
(C.05.010) Sponsors Obligations GCP Every sponsor shall ensure that a clinical trial is conducted in
accordance with good clinical practices including:
The clinical trial is scientifically sound and clearly described in a protocol
The clinical trial is conducted, and the drug is used, in accordance with the protocol and this Division
Overview of Division 5
www.hc-sc.gc.ca
16
(C.05.010) Sponsors Obligations contd Every sponsor shall ensure that a clinical trial is conducted in
accordance with good clinical practices including:
Systems and procedures that assure the quality of every aspect of the clinical trial are implemented
For each clinical trial site, the approval of a research ethics board is obtained before the clinical trial begins at the site
At each clinical trial site, there is no more than one QI
At each clinical trial site, medical care and medical decisions in respect of the clinical trial are under the supervision of the QI
Each individual involved in the conduct of the trial is qualified by education, training and experience
Overview of Division 5
www.hc-sc.gc.ca
17
(C.05.010) Sponsors Obligations contd Every sponsor shall ensure that a clinical trial is conducted in
accordance with good clinical practices including:
Written informed consent is obtained from every person before that person participates in the clinical trial but only after that person has been informed of:
The risks and anticipated benefits to his or her health arising from participation in the clinical trial
All other aspects of the clinical trial that are necessary for that person to make the decision to participate in the clinical trial
The requirements respecting information and records set out in section C.05.012 are met
The drug is manufactured, handled and stored in accordance with Good Manufacturing Practices (GMP
Overview of Division 5
www.hc-sc.gc.ca
18
(C.05.011) Labelling
Ensure that drug bears a label in both official languages detailing
Lot number; storage conditions; sponsor name and address, expiration date; protocol id and statement that it is an investigational product only to be used by a qualified investigator
Overview of Division 5
www.hc-sc.gc.ca
19
(C.05.012) Records The sponsor shall record, handle and store all information that
allows and supports the complete and accurate reporting, interpretation and verification of clinical trial data and that establishes that the clinical trial was conducted in accordance with GCP and these regulations
T
