The manufacture of a drug is a very long process that takes an average of 15 years from the initial discovery of the active substance to its commercialization. This process includes many steps such as research and development, clinical trials, evaluation, and approval by health authorities. To market a drug, companies must obtain marketing authorization (MA) for that drug from the relevant agencies (e.g., EMA for Europe, FDA for the United States).
The main mission of these agencies is to authorize and monitor drugs marketed in authorized countries. If companies obtain this authorization, they can then produce the drug on a large scale and market it in authorized countries.
Laws and regulations relating to the marketing of drugs have been gradually put in place over the last few centuries to establish rigorous and mandatory controls to prevent serious accidents. Several steps are required to obtain this authorization.
In general, the company must document the qualities of the drug in an extremely precise and rigorous manner according to three criteria: Quality – Toxicity/Safety – Efficacy.
- Quality: analytical section concerning the production process and product characteristics. Compliance with GMPs (i.e., Good Manufacturing Practices) is included.
- Safety/toxicity: assessment of risk and side effects.
- Efficacy: measurement of the drug’s ability to do what it is advertised to do.
Scientific evidence must be provided (i.e., role of clinical trials) because commercial success is not a proof of safety and efficacy. A “risk-benefit” analysis (toxicity/efficacy) is then carried out by the regulatory authorities to assess the value of a drug.
You should note that obtaining authorization does not mean the end of controls.
Once the drug is on the market, the companies that hold the authorization are required to continue monitoring the drug’s “behavior” throughout its life cycle. This is called pharmacovigilance, and the data is collected and sent to the relevant health authorities.
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