Regulatory affairs

Question 1

Medicinal pruct is defined by

Answer 1

any substance or combination of substances presented for treating or preventing disease in human beings

• making medicial diagnosis
• to restoring correcting or modifying physicological function in human beings

Question 2

Functional foods

Answer 2

claim to provide health benifits and are consumed as part of a normal food pattern

Question 3

Food supplements

Answer 3

• the purpose is to supplement a normal diet
• concentrated sources of nutrients or other substances with a nutritional or physiological effect
• alone or in combination
• marketed in dose form
• capsules, pastilles, tablets, pills

Question 4

Homeopathic preperations

Answer 4

Follows law of similars ‘like cures like’. the disease is treated by highly diluted substances that cause symptoms similar to the disease to activate the bodies self-healing mechanism

Question 5

herbal preperation =

Answer 5

medicinal product, exclusively containing as active ingredients one or more herbal substances or one or more herbal preperations, or one or more such herbal substances in combination with one or more such herbal preperations

Question 6

who is responsible for drug approavl in European Union?

Answer 6

EMA

Question 7

what is the core funciton of the EMA?

Answer 7

evaluating new drug applications to ensure their safety and efficacy

maintainging high standards in the pharmaceutical industry and safeguiarding publich health in the EU

Question 8

the process of EMA

Answer 8

application submission - pharmaceutical companies submit a MAA to EMA

Validation - Validation check of the submission

Scientific evaluation - safety, quality and efficacy assesment by rapporteur and co-rapporteur

Committee review - evaluation discussed with relevant scientific committee (CHMP). the committee recomends approval, rejection or undergo further assessment of the drug.

Commission decision - final decision by european comission, once approved: european marketing authorization & marketed in all EU member states.

Post-approval monotoring - EMA keeps on monitoring safety, pharmacovilgilance/collecting reports about adverse effects/ unexpected side effects and if necesssairy make label changes, restrictions or withdrawel from market.

Question 9

What is an MAA and what does it include?

Answer 9

Marketing authorization application - includes manufacturing processes, composition, preclinical studies and clinical trial studies

Question 10

what is the CHMP?

Answer 10

Committee for medicinal products for human use

Question 11

EMA =

Answer 11

the european medicine agency

Question 12

CBG & MEB =

Answer 12

college ter beoordeling van geneesmiddelen or medicines evaluation board

Ducht regulatory authority responsible for the evaluation and oversight of medicinal prodcuts int he netherlands

Ensuring safety, efficacy and quality of pharmaceuticals in the country

Question 13

RVG numbers =

Answer 13

registratiehouder van geneesmiddelen = tool that facilitates indentification and tracking of specific medication on Dutch market

Question 14

where do you find the RVG code?

Answer 14

on the packaging or label of medicinal product

Question 15

Generic drugs are:

Answer 15

identical copies of brand-name drugs with the same active ingredients, quality, safety and efficacy

• usually cheeper than brand-name counterparts
• undergo rigorous testing to meet the same regulatory standards for approval and use

Question 16

when do generic drugs come to the market?

Answer 16

after 10-15 years

Question 17

'’boost your immune system’’ is a

Answer 17

health claim

Question 18

criteria for health claims

Answer 18

• must be scientifically justified
• is de food or ingredient defined?
  is the claim effect defined?
  if 1 and 2 are met then… what is de evidence?

Question 19

what is the difference between a nutrition claim and a health claim?

Answer 19

nutrition claim: whcih nutrients are present
health claims: what it does

Question 20

examples of nutrition claims are:

Answer 20

low sugar/ high fiber/ energy reduced/ reduced fat

Question 21

you can only add an nutrition claim if…

Answer 21

it’s diffferent compared to the normal product - easy to prove compared to health claims

Question 22

Art 14 are the strongest health claims that

Answer 22

claim reducing of disease risk or referring to children’s development of health

Question 23

art. 13 are health claims that refer to

Answer 23

other than reduction to disease risk like
- body function
- Development
- weight loss/ satiety

Question 24

after evidence is proved it’s checked by

Answer 24

EFSA

Question 25

Which questions are adressed by EFSA?

Answer 25

- Quantity of the food needed to eat before effect is there - does it reflect scientific data? - doet it comply with creteria of regulation 1924/2006? - are the proposed conditions of use appropriate?

Question 26

how much of the claims are accepted

Answer 26

5%

Question 27

functional foods are ___ that have ____ due to specific ____ such as antioxidants, probiotics or added nutrients

Answer 27

regular food items, additional health benefits, bioactive compounds

Question 28

pharmaceuticals are specifically designed and formulated ___ developed for the ____ , ____ or ___ of various medical conditions and disease

Answer 28

drugs, diagnosis, treatment or prevention

Question 29

functional foods are typically consumed as part of ____ and ___ require prescription

Answer 29

normal/ regular diet, do not

Question 30

pharmaceuticals ___ prescription from ___ and are dispensed though ___ or ____

Answer 30

do require, healthcare professionals, pharmacies or healthcare providers

Question 31

functional foods promote ___, reduce the risk of ___ or enhance specific ____

Answer 31

general health, chronic disease, physiological functions

Question 32

pharmaceuticals are intended for treatment of ___ and ____, and ___ part of a regular diet

Answer 32

specific medical conditions and symptoms, are not

Question 33

Which one are strongest regulated, functional foods or pharmaceuticals?

Answer 33

pharmaceuticals are highly regulated and tested for safety, efficacy and quality

Question 34

available over the counter and safe for most individuals

Answer 34

functional foods

Question 35

have more potent and immediate effects, making them suitable for managing severe medical conditions and disease

Answer 35

pharmaceuticals

Question 36

functional foods are

Answer 36

natural of fortified foods with health benifits when consumed as part of a diet

Question 37

Who are responsible for monitoring and enforcing food supplement regulations in the Netherlands?

Answer 37

Dutch food and consumer prodcut safety authority (NVWA)

Question 38

Health claims foor supplements are regulated in accordance with

Answer 38

the EU's nutrition and health claims regulation (EC 1924/2006). Scientific evidence is required to support health claims and should not be labelled with drug claism

Question 39

manufactureres and distributors of food supplements are expected to comply with

Answer 39

good manufacturing practices (GMP) for safety and quality of products

Question 40

Why are there maximum levels for cerain vatamins established by the EU

Answer 40

prevent reach toxic level. such as vitamine A, D and B6

Question 41

Homeopathic preperatons are based on the principle:

Answer 41

like cures like

Question 42

core principles of homeopathic preperations

Answer 42

- law of similars: highly deluted remedy that produces sumptoms similar to the illness in a healthy person is beleived to stimulate the body's innate healing abilities - Minimum dose: serial dilution and succussion (shaking). The more dilute, the more potent. emphasizes larger doses of active ingredients. - Individualizesd treatment: match a specific remedy to individuals unique symptoms and overall cosntitution - takes phycal, emotional and mental state into assesment. - Holistic approach: adressing the root coaus of ailment rather than treating symptoms - self-healing response: the body's natural ability to heal itself - stimulate the boy's vatal force or life energy to restore balance and health -Safety: highly deluted and should have minimal to no toxic effects

Question 43

Homeopathic preperations fall under the responsibility of the ___ and have a ___ number. they should adhere to ___

Answer 43

MEB/ (CBG) RVH (register vereiging homeopathie) scientific data

Question 44

herbal medicinal products are

Answer 44

medicinal product exclusively containing - active ingredients one or more herbal substances or - one or more herbal preperations - or one or mure herbal substances combined with one or more herbal prep

Question 45

how are herbal medicinal products approval procedures?

Answer 45

same as standard drugs/ conventual phamraceuticals

Question 46

herbal food supplements ___ as herbal medicinal products

Answer 46

lack approval

Question 47

herbal supplements are often catergorized as

Answer 47

food supplements