6.1: Introduction – The Pharmaceutical Product Approval Process
- Page ID
- 39505
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Terminology
Before we begin diving into the regulation, it's important to understand standard pharmaceutical manufacturing terminology. Here are some relevant key terms.
- A pharmaceutical product is a chemical agent that acts on the body to create a therapeutic effect. A therapeutic effect may include the treatment or prevention of symptoms of illnesses, injuries, or disorders in humans and animals.
- The term drug applies to pharmaceuticals used in the diagnosis, cure, treatment, and prevention of disease and is substances, which are recognized by an official pharmacopeia or formulary. A new drug refers to drugs in which the safety and effectiveness of an application are not previously known.
- A generic drug is the same as a brand-name drug in dosage, safety, strength, how it is taken, quality, performance, and intended use. A generic drug must contain identical amounts of the same active ingredient(s) as the brand name product. The generic drug product must have an equal therapeutic effect as the brand-name drug.
- A New Molecular Entity (NME) is an active ingredient that has never been marketed in the United States in any form.
- A therapeutic biological product is a protein derived from living material that can be used to treat or cure diseases, such as cells or tissues.
- A biopharmaceutical is a specific type of drug created via genetic engineering of an organism. The term ‘biopharmaceutical agent' is synonymous with this kind of drug.
- A biosimilar is a biological product, which is ‘biosimilar’ to an FDA-licensed biological product (e.g., Biopharmaceutical, biologic, vaccine, proteins, tissues).
- A medical device definition is complicated. A medical device can range from a tongue depressor to a clinical testing kit, to a replacement hip. Due to the specialized complexity of devices and combination applications (for example, birth control implants), we will address device regulation in a later chapter.
CDER
The branch of the FDA that oversees drugs is the Center for Drug Evaluation and Research (CDER). This FDA Center evaluates a drug for both safety and effectiveness. It's important to note that they do not test the drug themselves but reviews the evidence the company sends them to ensure the drugs are safe and effective. The CDER team is constructed by physicians, chemists, pharmacologists, and other scientists.