NHP Approval Process

Question 1

True or false: the process for getting approval to sell a NHP is less intensive than for a pharmaceutical

Answer 1

true
however there are specific requirements focused on ensuring a safe and effective product which contains what it says it contains on the product label

Question 2

What must each NHP have?

Answer 2

a product license

Question 3

What does a NHP have if it has a product license?

Answer 3

an NPN

Question 4

What must each producer of NHPs have?

Answer 4

a site license
-this applies to companies that manufacture, package, label, and import the NHP

Question 5

When are product licenses granted?

Answer 5

if there is sufficient documented evidence of safety and efficacy for the product at the intended dose and for the specific claims being made

Question 6

What can companies do prior to application for product licenses?

Answer 6

have a pre-application meeting to determine in what category the product belongs and what data must be provided in the application including the proposal label

Question 7

What kind of documentation must be provided regarding the production of NHPs?

Answer 7

documentation must be presented that the product will be produced according to Good Manufacturing Practices (GMP), meeting quality and purity standards
-procedure is followed the exact same way every time using standard operating procedures
-it also incorporates quality control and quality assurance processes during manufacturing, packaging, and labelling

Question 8

What does an NPN or DIN-HM represent?

Answer 8

the label is a representation of what went into acquiring the product license, a quasi-legal document in itself
-misrepresenting the product label is a legal liability

Question 9

For the site license, in addition to meeting GMP standards, what must also be demonstrated?

Answer 9

adequate record keeping of product distribution
procedures for dealing with product recalls
ability to appropriately to store, handle, and deliver the product

Question 10

Describe characteristics of high risk health claims.

Answer 10

cure
treat
disease is serious
delay in treatment would be serious
potential for serious adverse effects
seen the least for NHPs

Question 11

Describe characteristics of medium risk health claims.

Answer 11

treat
prevent
specific disease
less serious disease
disclaimers (co-therapy, special populations)

Question 12

Describe characteristics of low risk health claims.

Answer 12

support health
normal physiological role
minor, self-limiting condition

Question 13

What are the risks related to safety and efficacy?

Answer 13

an ingredients physical or chemical form
the seriousness of the health claim and the conditions of use implied
the health impact from lower than expected performance of the product

Question 14

When might additional evidence be necessary to substantiate safety and efficacy, despite level of risk?

Answer 14

vulnerable sub-populations
any known interaction among ingredients
any known interaction with any other product/medication
any indication that the product/ingredient(s) alter diagnostic testing

Question 15

What are the factors that constitute risk?

Answer 15

patient issues
-ex: lack of supervision, stage of life, DIs, hydration, exertion
product quality issues
-ex: contaminants, adulteration, label issues, concentration errors
adverse events
-ex: DIs, idiosyncratic rxns, lack of data from clinical trials, little literature

Question 16

What is adulteration?

Answer 16

substitution with cheaper/other ingredient/pharmaceutical/wrong plant species

Question 17

What is pharmacovigilance?

Answer 17

post-marketing surveillance

Question 18

What is safety evidence based on for NHPs?

Answer 18

based on identified risks, including but not limited to:
-severity and seriousness of AEs
-probability or frequency of AEs
-severity and seriousness of the disease or condition for which it is used
-health impact of lower than expected performance
-use by vulnerable sub-populations
-inherent risks of the medicinal ingredients in the product

Question 19

What is a health claim?

Answer 19

a statement that indicates the intended beneficial effects of a product when used in accordance with its recommended conditions of use

Question 20

What are the 3 NHP claims based on characteristics of the health condition?

Answer 20

serious disease/condition claims
major disease/condition claims
minor disease/condition claims

Question 21

Describe serious disease/condition claims.

Answer 21

treatment, prevention or cure of diseases/conditions that require supervision by a HCP, or are debilitating or potentially life-threatening without effective treatment
treatment is vital to mitigate the health impact

Question 22

Describe major disease/condition claims.

Answer 22

treatment, prevention, or cure of diseases/conditions that are not naturally resolved within a timely manner or have potentially undesirable effects that may worsen or persist if proper treatment or care is not pursued in a timely manner

Question 23

Describe minor disease/condition claims.

Answer 23

treatment, prevention, risk reduction, or cure of diseases/conditions or symptoms that are expected to naturally resolve within a timely manner or for which lower than expected performance of the product should not pose a major risk to the person taking it under the recommended conditions of use

Question 24

What are the different health claims that are based on effect on health?

Answer 24

diagnostic claims
treatment claims
cure claims
risk reduction claims
prevention claims
general health maintenance, support, and promotion claims
antioxidant claims

Question 25

Describe diagnostic claims.

Answer 25

relate to the diagnosis of a disease, disorder, or abnormal physical state or its symptoms in humans

Question 26

Describe treatment claims.

Answer 26

relate to the treatment or partial treatment and mitigation of a disease, disorder, or abnormal physical state or its symptoms

Question 27

Describe cure claims.

Answer 27

describe a therapeutic effect that results in the elimination of a disease, disorder, or abnormal physical state in humans, either permanently or for a significant length of time

Question 28

Describe risk reduction claims.

Answer 28

based on significantly altering a major risk factor(s) for a disease or health-related condition -should be presented in a way that ensures consumers do not interpret them as prevention claims

Question 29

Describe prevention claims.

Answer 29

relate to interventions which are proven to significantly reduce the incidence of the disease

Question 30

Describe general health maintenance, support, and promotion claims.

Answer 30

describe the effect of a medicinal ingredient on restoration, correction, or modification of a structure or physiological function in the human body in a manner that maintains, supports, or promotes health

Question 31

Describe antioxidant claims.

Answer 31

for products with at least one medicinal ingredient that has antioxidant properties should be worded as general health support claims when the medicinal ingredient is an essential nutrient or as "source of" claims for other types of antioxidant ingredients

Question 32

Which health claims have the lowest requirement for efficacy data?

Answer 32

general health claims

Question 33

What is the proposal in discussion at Health Canada with low-risk NHPs?

Answer 33

deregulation -they would not bear an NPN and not be subject to the full approval process other than quality -the product would have to say that health claims have not been reviewed or approved by Health Canada

Question 34

Where does the GMP process start with herbals?

Answer 34

with the cultivation, harvesting and processing of plant material

Question 35

Describe GMP standards.

Answer 35

certified equipment and processes must be validated (SOP) personnel training and records and review of training procedures impurity testing a mechanism of consumer reporting of quality issues or AE batch testing for stability, use of reference material storage conditions for materials at all stages dust, exhaust fumes from processing must be contained labels, containers, closures must be specified and correct self-inspection process

Question 36

Differentiate quality control and quality assurance.

Answer 36

quality control: -focuses on products and equipment -shop floor or lab-based measurements -reactive -identifies faulty products quality assurance: -focuses on processes -ensures QC documentation is complete and correct -proactive -prevents faulty products

Question 37

What is the goal of QC?

Answer 37

to ensure the proper identity and purity of the product as stated on the package label