The life cycle of a drug is the entirety of phases a drug undergoes from its development to its eventual withdrawal from the market. These stages cover the entire life cycle of a drug, from the initial idea to the end of its use.
The life cycle (German: Lebenzyklus) of a drug comprises the following main phases:
- Research and development (German translation: Forschung und Entwicklung): This phase comprises the research and development of a new drug. It includes preliminary laboratory studies, animal testing and initial clinical trials on humans.
- Registration and marketing authorization: After successful clinical trials, a drug must be approved by regulatory authorities. Once it is approved, it can be placed on the market.
- Manufacture and distribution: The drug is produced on an industrial scale and sold on the market. This stage includes the manufacture, packaging, labeling and distribution of drugs.
- Market launch: The drug is made available to patients and healthcare providers for the treatment and prevention of diseases.
- Pharmacovigilance (German: Pharmakovigilanz): Regulatory authorities and pharmaceutical companies monitor the safety and efficacy of a drug throughout its entire life cycle.
- Post-marketing studies: In some cases, additional clinical trials are conducted after a drug has been approved to obtain additional information about its safety (translation into German: Sicherheit, Unbedenklichkeit) and efficacy.
- Market withdrawal: A drug can be withdrawn from the market for various reasons, e.g. patent expiry, low demand or the discovery of serious side effects.
The life cycle of a drug is a complex and lengthy process that involves many steps and requires strict compliance with regulations and guidelines. This cycle helps to ensure the safety and efficacy of drugs on the market while also making medical innovation possible.
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