When I am running GMP training courses I often ask the delegates at the start of the course what a medicine actually is. This always prompts some interesting discussion and gets people thinking – which is never a bad thing on a training course. Typical answers include “something to cure a disease” and sometimes “something to prevent a disease” and often “something to make you feel better”. These are all good definitions – I especially like the one “something to make you feel better”. Whilst this is true there are also lots of non-medicinal things that can make you feel better – a glass of wine, watching your team win at sport, seeing your family and so on, none of which can be classed as medicines.
The place I turn to to get a definition of a medicine is the EU GMP Glossary, where there is a definition of a Medicinal Product. The definition is in two parts:
Any substance or combination of substances presented for treating or preventing disease in human beings or animals. Any substance or combination of substances which may be administered to human beings or animals with a view to making a medical diagnosis or to restoring, correcting or modifying physiological functions in human beings or in animals is likewise considered a medicinal product.
From the above definition you will see that medicines apply to both humans and animals, and animal medicinal products are subject to more-or-less the same GMP rules and regulations as human medicines.
Let’s look at the definition part by part. The first part to start with:
Any substance or combination of substances presented for treating or preventing disease in human beings or animals.
This covers classic assumptions and ideas about medicines. Vaccines are included here (to prevent) as are antibiotics (to treat).
The second part covers a much broader scope of the use of medicines, and includes a number of uses of medicines that may not be immediately obvious.
Any substance or combination of substances which may be administered to human beings or animals with a view to making a medical diagnosis or to restoring, correcting or modifying physiological functions in human beings or in animals is likewise considered a medicinal product.
From this we can see two further uses of medicines:
Making a medical diagnosis
This includes products taken to help conditions show up during x-rays and products taken to force the body into a reaction as part of trying to identify a possible medicinal condition (such as allergies).
Restoring, correcting or modifying physiological functions
This includes the contraceptive pill, pain relief and use of hormone products.
So you can see that a medicine is quite a complicated thing, with a number of definitions that go beyond “making you feel better”. Whilst making you feel better is probably the goal of all medicines you will note that these four words do not appear in the definition itself!
I hope that this is of interest. Feel free to add comments below. For further details of the courses we offer, please visit our website.
THIS ARTICLE WAS PUBLISHED IN 2012 AND REVIEWED AND RE-PUBLISHED IN NOVEMBER 2022. THE MAJOR CHANGE WAS THE ADDITION OF THE VIDEO BELOW.
Annex 1 has finally arrived, 25th Aug 2022 saw the publication of Annex 1. Normally, updates to GMP chapters and Annexes have a 6-month lead time for implementation. In the case of the new Annex 1, the lead time is 12 months, except for clause 8.123 relating to lyophilization which has 24 months lead time.
Annex 1 was first issued in 1971 as the only annex in the first ever UK guide to Good Manufacturing Practice. Since then, there have been several updates but not full revisions. In 2012 there was a proposal to revise Annex 1 with a re-proposal in 2014 by the UK’s MHRA. At the time, a full rewrite was considered unlikely and instead the intention was to provide a document that would confirm regulatory expectation and as such, not place any new requirements or costs on the pharmaceutical industry.
While this principle, is still upheld, it was clear from the first draft for public comment of December 2017, that a rewrite was being undertaken. The first draft created around 6200 comments coming from regulatory organizations, such as the pharmaceutical cooperation scheme, regulatory bodies outside of the EU, support organizations such as the Parenteral Drug Association, the Parenteral and Healthcare Sciences Society, the Pharmaceutical Microbiology Interest group as well as representatives from the manufacturers within the pharmaceutical industry to name just a few. Rarely do updates require a second public consultation but in the case of the annex 1 update a second draft was issued in March 2020 although this was a more targeted review in terms of the sections and clauses that comment was being sought for.
About the author
Andy started working in the Pharmaceutical industry in 1985 as a lab technician for Smith & Nephew. Following this he had a number of roles culminating when he took over as QA Microbiology Manager. In 2003 he moved into Pharmaceutical Training and then in 2007 he moved back into Microbiology when he took up the position of Microbiology Manager for Catalent Pharma Solutions. Since 2012 he has operated as a consultant specialising in Microbiology and Quality Systems.
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