Chapter 12: Drugs and society
From chemical compound … Up to treatment
From now on, we talk about a treatment, the marketed drugs. So, we are not talking about an API or
about compounds. The development of new drugs can be about derivates from natural or herbal
products. This is a trial and error procedure within the (semi) synthetic drug development. The ‘me
too’ drugs are drugs that are similar to a drug which is already on the market. This drug is already
proven to be safe and efficacy. However, the ‘me too’ drugs have some small adaptations in which it
works better (for example ampicillin and amoxicillin). The treatment can have a targeted
(semi-)synthetic or biotechnological design. In the preclinical phase, only in vitro and animal studies
were performed. In the clinical development, we check the benefit/risk in humans. We perform the
dose finding studies and the evaluation of toxicity in healthy volunteers (phase I); we evaluate the
pharmacokinetics and efficacy in small groups of patients (phase II); and we perform randomized
controlled trials comparing the drug candidate with the current ‘golden standard’ in patients (phase
III). Phase (I), II and III are the “ideal situation”: there are relatively small groups of patients with
clearly defined inclusion and exclusion criteria and the drug is administered in controlled
circumstances.
After marketing authorization, the drug is used in a broad scale of the population (“Drugs and
society”). This is the real-life situation: There will be unpredictable situations and patients,
uncontrolled circumstances (altered metabolism, altered clearance, concomitant intake with food or
other drugs, low compliance, …). This is also phase IV, there is need for pharmacovigilance and need
for strict regulations to optimize use and handling or drugs in a proper way in the society.
Regulatory agencies – National legislation
In the USA, the regulatory agency is the FDA (Food and Drug Administration); in Europe, this is the
EMA (European Medicine Agency); and in Belgium, this is the FAGG (FAHMP: Federal Agency for
Health and Medicinal products). Within the FAHMP, we have the Committee for Drug Use in Humans.
This committee discusses every new drug which is coming on the market and we talk about the new
measurements and regulations for this drug to use in such a big group of humans. The regulation of
healthcare in Belgium depends on very detailed regulations and legislation: the goal of this course is
to highlight some of the regulatory aspects or common terminology and concepts of the regulations
and legislation.
Content
I. Regulatory aspects on drugs
The law on drugs (25 March 1964) is updated in the pharmaceutical legislation of 1 May 2006. Art. 1
al. 1 stated: “Each unique of composite substance, presented with therapeutic or prophylactic
characteristics in human illness”. So, a drug is a product without therapeutic or prophylactic
characteristics, but presented with these characteristics. Art. 1 al. 2 states: “Every unique or
composite substance that can be administered in humans to restore physiological functions, or to
improve or change these functions by a pharmacological, immunological or metabolic effect, or to
establish a medical diagnosis”. So, a very broad domain of substances should be named as a “drug” in
Belgium!
However, what is meant with “substance”? This is each product, independent of its origin, amongst
others:
Human origin: human blood, tissue, cells (e.g. stem cells) and derived products
Animal origin: such as micro-organisms, organ-derived product (e.g. vaccines, chondroitin,
glucosamine, …)
Derived from plants: substances from plants purified by extraction (e.g. taxol-derivatives)
Chemical origin: (semi)synthesis
Pagina 1 van 12
From chemical compound … Up to treatment
From now on, we talk about a treatment, the marketed drugs. So, we are not talking about an API or
about compounds. The development of new drugs can be about derivates from natural or herbal
products. This is a trial and error procedure within the (semi) synthetic drug development. The ‘me
too’ drugs are drugs that are similar to a drug which is already on the market. This drug is already
proven to be safe and efficacy. However, the ‘me too’ drugs have some small adaptations in which it
works better (for example ampicillin and amoxicillin). The treatment can have a targeted
(semi-)synthetic or biotechnological design. In the preclinical phase, only in vitro and animal studies
were performed. In the clinical development, we check the benefit/risk in humans. We perform the
dose finding studies and the evaluation of toxicity in healthy volunteers (phase I); we evaluate the
pharmacokinetics and efficacy in small groups of patients (phase II); and we perform randomized
controlled trials comparing the drug candidate with the current ‘golden standard’ in patients (phase
III). Phase (I), II and III are the “ideal situation”: there are relatively small groups of patients with
clearly defined inclusion and exclusion criteria and the drug is administered in controlled
circumstances.
After marketing authorization, the drug is used in a broad scale of the population (“Drugs and
society”). This is the real-life situation: There will be unpredictable situations and patients,
uncontrolled circumstances (altered metabolism, altered clearance, concomitant intake with food or
other drugs, low compliance, …). This is also phase IV, there is need for pharmacovigilance and need
for strict regulations to optimize use and handling or drugs in a proper way in the society.
Regulatory agencies – National legislation
In the USA, the regulatory agency is the FDA (Food and Drug Administration); in Europe, this is the
EMA (European Medicine Agency); and in Belgium, this is the FAGG (FAHMP: Federal Agency for
Health and Medicinal products). Within the FAHMP, we have the Committee for Drug Use in Humans.
This committee discusses every new drug which is coming on the market and we talk about the new
measurements and regulations for this drug to use in such a big group of humans. The regulation of
healthcare in Belgium depends on very detailed regulations and legislation: the goal of this course is
to highlight some of the regulatory aspects or common terminology and concepts of the regulations
and legislation.
Content
I. Regulatory aspects on drugs
The law on drugs (25 March 1964) is updated in the pharmaceutical legislation of 1 May 2006. Art. 1
al. 1 stated: “Each unique of composite substance, presented with therapeutic or prophylactic
characteristics in human illness”. So, a drug is a product without therapeutic or prophylactic
characteristics, but presented with these characteristics. Art. 1 al. 2 states: “Every unique or
composite substance that can be administered in humans to restore physiological functions, or to
improve or change these functions by a pharmacological, immunological or metabolic effect, or to
establish a medical diagnosis”. So, a very broad domain of substances should be named as a “drug” in
Belgium!
However, what is meant with “substance”? This is each product, independent of its origin, amongst
others:
Human origin: human blood, tissue, cells (e.g. stem cells) and derived products
Animal origin: such as micro-organisms, organ-derived product (e.g. vaccines, chondroitin,
glucosamine, …)
Derived from plants: substances from plants purified by extraction (e.g. taxol-derivatives)
Chemical origin: (semi)synthesis
Pagina 1 van 12
