In official medical and pharmaceutical texts, one may encounter many terms that refer to a medicine: medication, medical product, drug, drug product, pharmaceutical product, active substance, drug substance, active ingredient, and a few others. What is the difference between them? Let’s take a closer look at the official terms that are used by healthcare authorities in the EU (EMA) and the US (FDA) and by WHO.
The most broad official terms are medicinal product (used by EMA), drug (used by FDA), and pharmaceutical product (used by WHO along with drug). You will see from the definitions below that these terms are synonyms.
According to Directive 2001/83/ECof the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use:
Medicinal product: (a) Any substance or combination of substances presented as having properties for treating or preventing disease in human beings; or
(b) Any substance or combination of substances which may be used in or administered to human beings either with a view to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a medical diagnosis.
What is a substance in this context? Substance is defined in the Directive 2001/83/EC as:
Any matter irrespective of origin which may be:
— human, e.g. human blood and human blood products;
— animal, e.g. micro-organisms, whole animals, parts of organs, animal secretions, toxins, extracts, blood products;
— vegetable, e.g. micro-organisms, plants, parts of plants, vegetable secretions, extracts;
— chemical, e.g. elements, naturally occurring chemical materials and chemical products obtained by chemical change or synthesis.
To make a medicinal product, you cannot take just any substances (also called ingredients, components of the product). You need at least one that exerts pharmacological, immunological or metabolic action, or is used to make a medical diagnosis. This ingredient is called active substance and is defined in Europe as:
Any substance or mixture of substances intended to be used in the manufacture of a medicinal product and that, when used in its production, becomes an active ingredient of that product intended to exert a pharmacological, immunological or metabolic action with a view to restoring, correcting or modifying physiological functions or to make a medical diagnosis.
Note that active substance is called active ingredient when used in production of a medicinal product. We will look at the production-related terms in the second part of this overview.
As noted above, US FDA does not use the term “medicinal product” but uses an equivalent term “drug”. According to FDA Glossary of Terms:
Drug:
— A substance recognized by an official pharmacopoeia or formulary.
— A substance intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease.
— A substance (other than food) intended to affect the structure or any function of the body.
— A substance intended for use as a component of a medicine but not a device or a component, part or accessory of a device.
Biological products are included within this definition and are generally covered by the same laws and regulations, but differences exist regarding their manufacturing processes (chemical process versus biological process.)
WHO gives the following definitions:
Drug:
Any substance or pharmaceutical product for human or veterinary use that is intended to modify or explore physiological systems or pathological states for the benefit of the recipient. The terms drug, medicine and pharmaceutical product are commonly used interchangeably.
Pharmaceutical product:
Any substance or combination of substances marketed or manufactured to be marketed for treating or preventing disease in human beings, or with a view to making a medical diagnosis in human beings, or to restoring, correcting or modifying physiological functions in human beings.
Being the broadest concepts, medicinal product (EMA) / drug (FDA, WHO) / pharmaceutical product (WHO) include the following narrower terms: finished product / drug product, active substance / drug substance, active pharmaceutical ingredient. We will go through their definitions and a few other related terms in the second part of this overview.
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