Lecture

Regulation of Therapeutic Products

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In course

BIO-455: Introduction to law and ethics

The aim of this course is to introduce students to the basic legal and ethical concepts relevant to research in the life sciences and its translational application, and to provide them with the essential tools to identify legal and ethical issues in their ...

Description

This lecture covers the regulation of therapeutic products, including the classification, manufacturing requirements, market placement conditions, and enforcement authorities. It delves into the distinction between therapeutic products, foodstuffs, and cosmetics, emphasizing the importance of proper authorization for medicines. The instructor explains the legal framework governing health protection in Switzerland, detailing laws on medicines, food, narcotics, and dangerous substances. The lecture also explores the authorization process for therapeutic products, from manufacturing to distribution, highlighting the significance of Swissmedic approvals. Additionally, it discusses the lifecycle of a human-use drug, from research to post-marketing surveillance, and the pharmacovigilance obligations. The session concludes with insights on advertising regulations, inspections, administrative measures, and sanctions in the pharmaceutical sector.

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Related concepts (32)

Biopharmaceutical

A biopharmaceutical, also known as a biological medical product, or biologic, is any pharmaceutical drug product manufactured in, extracted from, or semisynthesized from biological sources. Different from totally synthesized pharmaceuticals, they include vaccines, whole blood, blood components, allergenics, somatic cells, gene therapies, tissues, recombinant therapeutic protein, and living medicines used in cell therapy. Biologics can be composed of sugars, proteins, nucleic acids, or complex combinations of these substances, or may be living cells or tissues.

European Medicines Agency

The European Medicines Agency (EMA) is an agency of the European Union (EU) in charge of the evaluation and supervision of pharmaceutical products. Prior to 2004, it was known as the European Agency for the Evaluation of Medicinal Products or European Medicines Evaluation Agency (EMEA). The EMA was set up in 1995, with funding from the European Union and the pharmaceutical industry, as well as indirect subsidy from member states, its stated intention to harmonise (but not replace) the work of existing national medicine regulatory bodies.

Pharmaceutical industry

The pharmaceutical industry discovers, develops, produces, and markets pharmaceutical drugs for the use as medications to be administered to patients (or self-administered), with the aim to cure and prevent diseases, or alleviate symptoms. Pharmaceutical companies may deal in generic or brand medications and medical devices. They are subject to a variety of laws and regulations that govern the patenting, testing, safety, efficacy using drug testing and marketing of drugs. The global pharmaceuticals market produced treatments worth $1,228.

Statistical classification

In statistics, classification is the problem of identifying which of a set of categories (sub-populations) an observation (or observations) belongs to. Examples are assigning a given email to the "spam" or "non-spam" class, and assigning a diagnosis to a given patient based on observed characteristics of the patient (sex, blood pressure, presence or absence of certain symptoms, etc.). Often, the individual observations are analyzed into a set of quantifiable properties, known variously as explanatory variables or features.

Manufacturing resource planning

Manufacturing resource planning (MRP II) is a method for the effective planning of all resources of a manufacturing company. Ideally, it addresses operational planning in units, financial planning, and has a simulation capability to answer "what-if" questions and is an extension of closed-loop MRP (Material Requirements Planning). This is not exclusively a software function, but the management of people skills, requiring a dedication to database accuracy, and sufficient computer resources.

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