3 Facts About Product Monographs for Students in Regulatory Affairs Courses

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Pharmaceuticals on the market have the ability to improve the lives of many Canadians. They are used to treat illness, pain, and disorders, and they help people live normal and healthier lives. But if individuals taking pharmaceuticals and the doctors who are prescribing them don’t have the proper information, issues may arise. This is why Health Canada ensures most approved drugs have a product monograph.

A product monograph is a government-regulated scientific document that lists the drug, its properties, and any health claims the product makes. It includes essential information for doctors and healthcare professionals which allows them to make educated decisions about prescribing and administering the drug. It can also help individuals themselves make sure they are taking the product correctly.

Students in pharmaceutical regulatory courses learn about product monographs during their studies. To get a head start, read on to discover three interesting facts about product monographs.

1. Students in Regulatory Affairs Courses Might Know Drug Monographs Have Three Sections

As you’ll soon learn in your regulatory affairs courses, proper drug monographs have three core sections. Each section is responsible for conveying essential information about the drug to parties who need it like doctors, nurses, and patients. Each drug manufacturer must comply with the drug monograph standards set out by Health Canada. The sections that must be included in a drug monograph are:

  1. Health Professional Information, which helps medical professionals prescribe the drug
  2. Scientific Information about the drug make up, clinical trials, pharmacology, and studies
  3. Consumer Information, which is a simplified version of sections 1 and 2 for those taking the drug

The information provided by a drug monograph is essential in order to maintain the safety of those who may be taking it. Because drug monographs have to be completely free of any promotional material, doctors and patients can rest assured the information being presented is accurate and scientifically reliable.

2. Students in Regulatory Affairs Courses Should Know Some Drugs May not Have a Monograph

Although drug monographs are deemed extremely important by professionals with careers in regulatory affairs, not every drug will have a product monograph. Drugs that have been on the market for a long period of time and have become a standard pharmaceutical may not be required to have a monograph. This is because they have been on the market for so long that their safety and efficacy is widely regarded and trusted.

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If a drug does not have a product monograph, there will usually be other information included in the packaging like labels, prescribing information, and other general information.

3. Students in Regulatory Affairs Courses Might Know Monographs Can Be Submitted in One Language

Since Canada has two official languages, English and French, companies that manufacture drugs are only required to submit a monograph in one of the two official languages. The document will be reviewed by regulatory professionals in whichever language it is submitted in. However, if the product gets approved, the monograph will need to be translated by the drug manufacturer.

Manufacturers have to be particularly careful to make sure the translation has exactly the same meaning and information as the original version. If not, it could cause regulatory issues and could put individuals consuming the drug at risk of overdosing, not following the storage instructions, or other harmful occurrences.

Are you interested in a career in pharmaceutical regulatory affairs?

Contact AAPS today to learn how you can get started!