QMRS Services
PRODUCT REGISTRATION
As per Section (5) of the Natural Health Products Regulations, Health Canada: Natural Health Products Directorate requires two types of reports to be submitted, with the product licence application. The first is the Evidence Summary Report, which is designed to provide the Directorate assessor with information about the products safety and efficacy. The second report is the Quality Summary Report, which is organized to cover the specifications of the finished product. The NHPD encourages applicants to devote sufficient time to prepare clear and precise reports.
1. EVIDENCE SUMMARY REPORT (Safety & Efficacy)
A. Evidence To Support Traditional Use
B. Evidence To Support Non-Traditional Use
3. GOOD CLINICAL PRACTICES AUDIT
A. Contract Research Organization (CRO) Evaluation
C. Clinical Research Documents
1. EVIDENCE SUMMARY REPORT (Safety & Efficacy)
The report template contains three parts. Part one is to present evidence to support the use of the product for each medicinal ingredient provided on the product licence application form. Part two, is allocated to provide information on the safety of the product (the 12 safety factors). And the last part is to describe the search strategy and the references.
The followings are to display the NHPD requirements, and how QMRS can assist you to fulfill these requirements.
A. Evidence To Support Traditional Use
Applicants must provide at least two independent references that support the conditions of use. However, if one reference only is available, an EXPERT OPINION REPORT would be considered by the NHPD as a possible substitute for a second reference.
The regulations require that the experts committee must comprise of minimum three people; at least one of them must have a scientific qualifications including experience in research methods and training in evidence-based health care.
HOW CAN WE HELP?
Being a Ph.D. degree holder from University of London in the field of Human Nutrition (1981), with a number of publications in Nutrition, Dietetic and Health care, I am confident that QMRS can fulfill your need. Namely, the principal name could be one of your EXPERT COMMITTEE MEMBERS. Please click on Principal Message to review my qualifications and publications (this information needed also, by NHPD to fulfil the requirements for Third Party Auditor/Quality Assurance Person).
We are also pleased to point out that Dr. Victor Manolii (Ph.D from Odessa, Moldova) with his 18 years of scientific and practical experience in plant breeding, genetics, biotechnology and molecular biology analysis, is one of our team of experts. Therefore, his name and expertise is available for your use.
Just send us your enquiry to info@qmrs.com and we will be very pleased to contribute to your success
B. Evidence To Support Non-Traditional Use
The evidence requirements to support a non-traditional use claim are more stringent than what is required to support a traditional use. There are many types of evidence, but all are based on scientific research, and findings. The following are the many types of scientific evidence, which is accepted by NHPD.
A. Systematic Reviews
Reviewing scientific literature requires special skills, and training. Also, to combine, and summarize the results of several clinical trials using statistical methods involve a great deal of expertise, and may be postgraduate education. Since this type of evidence is considered the strongest level in the “Strength of Evidence Grading System”, it should be the first choice for any applicant.
QMRS can help you in two ways:
YOU can provide us with all scientific articles on your active ingredient, and we will review it, analyze it, and summarize the results to suit your recommended use.
OR, we can also, search and gather the scientific data on your behalf, then we can proceed with the analysis and summarize it as explained earlier. Please contact us directly to discuss your needs.
B. Clinical Studies
Clinical studies is considered by NHPD as the best scientific evidence applicants could provide (level I and II in the grading system).
The fact is that, this approach is very costly, not only from the monetary point of view, but also, requires a lot of time to prepare for the study, and a very well established organizational structure to allow for such an activity (even if the project will be given to Clinical Research Organization). Therefore, clinical studies may be not the first choice by many companies. But, if the product is new, and there is little available data on the product active ingredient(s), in such a case, clinical studies will be necessary and not optional.
Let us (QMRS) help you to design a simple study to save your money. We can also, supervise, and monitor the study as well as write, and publish the results.
If you are a small or medium size manufacturer, you will certainly, benefit from our package, which include (in addition to designing and monitoring the study), providing you with many essential SOPs and Forms, which are written specifically for clinical research activities. (see DOCUMENTATION SUPPORT for the details).
C. Descriptive and Observations Studies
As NHPD indicated, “well-designed descriptive or observational studies can also be classified as comparative studies, correlation, and case-control studies, and such studies may also provide valuable information”. These types of evidence classified under level III in the “Evidence Grading System”.
It is obvious that, such studies are less demanding compared with clinical trials. QMRS can design with you these studies, to ensure you will pay less money and receive adequate / accurate feedback to support your product claim.
D. Other Evidences
Textbooks, pharmacopoeias, academic journals, reputable regulatory agencies, and pre-clinical studies are all high-quality source of information to support product claim. If you do not have access to such sources, we can do the needed search for you.
2. QUALITY SUMMARY REPORT
This is the second type of evidence report required by HC: NHP Directorate to support product registration. The objective of this report is to provide the ministry with a description of the product identity, purity, quality, potency, and tolerance limits. The needed information is very technical; covering aspects such as the manufacturing process, sterilization process, analytical procedures, and its validation & justification for use.
Obviously, these requirements involve a lot of work, information, and expertise. To make your task easier, QMRS can provide you with the needed documents, (such as equipment & facility qualifications, sterility tests, and materials specifications policies). Please check ON-LINE PURCHASE, and DOCUMENTATION SUPPORT for the details).
3. GOOD CLINICAL PRACTICES AUDIT
Good Clinical Practices means that the clinical trials are designed and conducted according to specific requirements (practices) to ensure the protection of the rights, safety and well-being of clinical trial subjects and other persons. (Health Canada; Guidance for clinical trial sponsors: clinical trial applications, 2003).
Health Canada also define clinical trials as “an investigation in respect of a drug for use in humans that involves human subjects, and that is intended to discover or verify the clinical, pharmacological or pharmacodynamic effects of the drug, identify any adverse events in respect of the drug, study the absorption, distribution, metabolism, and excretion of the drug or ascertain the safety or efficacy of the drug.”
Auditing is the process of examining all trial-related activities, and documentations to determine whether the evaluated activities were conducted, and the data was recorded, analyzed, and accurately reported according to the protocol, sponsor’s SOP’s, the generally accepted clinical practices, and the applicable regulatory requirements.
Audit Objectives
In view of the above background, clinical trials sponsors need to establish a clinical research program to fulfill the above indicated requirements. Specifically, the purpose of clinical trials audit is to answer many questions such as:
Are the investigator(s) qualified to conduct the trial?
Is the institution / site well equipped?
Is the Research Ethics Board (REB) to approve the study, meets health Canada requirements?
Did the subjects receive the product under investigations (Drug accountability)?
Was the informed consent form available for all trial-enrolled subjects?
Were any adverse reactions, or case of death reported?
Was the result correctly reported?
Was the study protocol well followed?
Is there monitoring system in place?
Are all clinical trial documentations established, and available (such as sponsor trial master file, and trial site file)?
Needless to say, these are not all of the questions, which need to be answered. In brief, a periodic audit of all activities related to clinical trials must be conducted , and documented in order to ensure compliance with current regulations.
QMRS ROLE
QMRS team can help you for better preparation in:
A. Contract Research Organization (CRO) Evaluation
As per the International Conference on Harmonization (ICH) definition, CRO, “is a person, or an organization (commercial, academic, or other), contracted by the sponsor to perform one or more of a sponsor’s trial related duties, and functions".
In accordance with the above definition, QMRS can evaluate the qualifications of the CRO by conducting the following activities:
Clinical laboratory evaluation
Contract monitor evaluation
Data management evaluation
An audit checklist will be available upon request for each one of these parameters. You might choose to purchase the checklist to do the evaluation by your self for your self (see DOCUMENTATION SUPPORT). Or, you might ask us to help you; where our experts will be pleased to do these tasks on your behalf in a cost-effective manner. Our audit approach, procedures, and rate will be similar to the GMP audit. However, we will be prepared to customaries our methodology to suit your needs. Just call us at 613-526 0471, or write to info@qmrs.com for free consultation.
B. Essential Documents Audit
We can assess the adequacy (completion) of the clinical trials essential documents in the investigator/institution site, and/or your (the sponsor) files. This evaluation could be conducted:
Before the clinical trial commence.
During the clinical trial implementation.
Or/and after completion, or termination of the clinical trial.
QMRS prepared detailed checklists, and forms for your use. Please, click on: ON-LINE PURCHASE, and DOCUMENTATION SUPPORT for more information.
Although QMRS documents are well designed, and easy to use by your employees, our experts are still ready to travel anywhere to conduct the audit on your behalf.
C. Clinical Research Documents
QMRS already prepared many Standard Operating Procedures, and forms to be available for your use. It might be important to mention that the documents contents are based on the ICH; GCP: Consolidated Guideline; 1997, which is adopted by Health Canada. The lists of documents are displayed under DOCUMENTATION SUPPORT, and could be purchased on line ON-LINE PURCHASE.
If you are unable to find specific titles (subjects), please let us know, because many documents are under development /review, and could be available within a very short time upon your request.
In brief, whether you are seeking traditional or non-traditional product licensing, we are fully equipped to prepare your registration package, and manage all the communications with Health Canada. It is worth mentioning that this activity will be directed in QMRS by Dr. H. ASHAER (M.D, M.Sc).
The sponsor shall record, handle and store all information in respect of a clinical trial in a way that allows its complete and accurate reporting as well as its interpretation and verification.
Source: Canada Gazette (June 18, 2003), Natural Health Products Regulations, Part 4: Records, 76.(1).
