United States Public Health Service Act

The United States Public Health Service (PHS) originated in name in 1798; however, the PHS Act of 1944 consolidated many previous federal laws relating to public health services and newly mandated the licensing of human biologic products, or their suspension if they endangered public health. The PHS Act is codified and enforced by several federal agencies under the Department of HHS.

The Virus-Serum-Toxin Act

The Virus-Serum-Toxin Act (VSTA) (as amended) requires licensing of animal vaccine products and establishments, and requires permits for the importation of animal biologic products. The Veterinary Biologics Program of the United States Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) enforces the VSTA by codifying regulations in 9 CFR 101–118.

It should be noted that the term “pharmaceuticals” is interchangeable with “drugs” in the United States and with the term “medicinal products” in the rest of the world. It is an umbrella term that includes biologics (usually large-molecule therapeutic entities greater than 5 kDaltons) and nonbiologic drugs (usually small-molecule entities less than 5 kDaltons). Biologics, like other drugs, are used for the treatment, prevention, or cure of disease in humans; however, they are generally derived from living material and are complex in structure and often less definitively characterized than nonbiologic drugs. Biologics are not characterized down to every element, ionic state, water of hydration, three-dimensional structure, including disulfide bond, hydrogen bond, or protein quaternary subunit.

European Union Legal System Relevant to Pharmaceuticals

Within the member countries of the European Union (EU), regulations, directives, and decisions are the principal forms of legislation governing pharmaceutical manufacturing and pharmaceutical marketing. Specifically, a “regulation” is a binding legislative act that must be applied in its entirety across the EU. A “directive” is a legislative act that sets out a goal that all EU countries must achieve; however, it is up to the individual countries to decide how to achieve that goal. A “decision” only deals with a particular issue and specifically mentioned persons or organizations.

Member states of the EU enact national laws to enforce the provisions of EU directives. Directive 2001/83/EC (similar to the United States FDCA) continues to be amended over time but maintains its original structure and general content (comprising Articles and Annexes). This directive requires each holder of a medicinal product manufacturing authorization to have “permanently and continuously at his disposal the services of at least one qualified person [QP].” The specific duties of the QP, as well as the guidelines for pharmaceutical good manufacturing practices (GMP), are detailed in the Eudralex Volume 4, Part I.

Japan Legal System Relevant to Pharmaceuticals

The Ministry of Health, Labour, and Welfare (MHLW) (the Koseirodosho) was established by a merger of the Ministry of Health and Welfare and the Ministry of Labour on January 6, 2001, as part of the government program for reorganizing government ministries. The MHLW, which was originally established in 1938, was in charge of the improvement and promotion of social welfare, social security, and public health, and the new organization has the same tasks. The department consists of the ministry proper, affiliated institutions, councils, local branches, and an external organization. The MHLW is in charge of pharmaceutical regulatory affairs in Japan (veterinary drugs are under the jurisdiction of the Ministry of Agriculture, Forestry and Fisheries). The Pharmaceutical and Food Safety Bureau (PFSB) undertakes the main duties and functions of the Ministry: it handles clinical studies, approval reviews, and post-marketing safety measures, that is, approvals and licensing for ensuring food and drug safety.

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