Chapter 2: Regulations and Guidances

It is necessary to possess the ability to interpret regulations and guidelines as published or administered by the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Cooperation Scheme (PIC/S), Health Canada, the World Health Organization (WHO), the International Conference on Harmonization (ICH), the European Medicines Agency (EMA), the United States Food and Drug Administration (FDA), the Therapeutic Goods Administration (TGA), United States Department of Agriculture (USDA) 9 CFR (Code of Federal Regulations), USDA Veterinary Service, and the International Pharmaceutical Excipients Council (IPEC).

Pharmaceutical Inspection Convention and Pharmaceutical Inspection Cooperation Scheme

PIC/S are two authorities that provide guidance in the field of good manufacturing practices (GMP). The goal of PIC/S is to lead the international development, implementation, and maintenance of harmonized GMP standards and quality systems in the field of medicinal products. This goal is to be attained by developing and promoting harmonized GMP standards and guidance documents. Additionally, PIC/S promotes the training of authorities and inspectors to ensure competent GMP assessments. Currently, 44 regulatory bodies participate in PIC/S, including representatives from South America, Europe, Asia, Australia, and North America.

Health Canada

A federal department known as Health Canada is responsible for helping Canadians maintain and improve their health while respecting individual choices and circumstances. The goal of the department is to maintain a balance between the potential health benefits and risks posed by all drugs and health products.

Branch-wide compliance and enforcement activities are the responsibility of the Inspectorate, enabling consistency of approach across the spectrum of regulated products. Core functions include compliance monitoring, compliance verification and investigation—supported by establishment licensing of drugs and medical devices, and laboratory analysis.

Quality assurance (QA) that ensures that drugs are consistently produced and controlled in such a way as to meet the quality standards appropriate to their intended use, as required by the marketing authorization, includes GMP. Inspections are conducted to verify the compliance with GMP (Part C, Division 2 of the Food and Drugs Regulations), which is a requirement for the issuance of an establishment license. The Inspectorate has developed the GMP guidelines and a series of guides and other related documents to ensure a uniform application of the established requirements and to help the industry comply.

World Health Organization

WHO is responsible for providing leadership on global health matters. Within the United Nations system, WHO is the directing and coordinating authority for health, working to shape the health research agenda, set norms and standards, articulate evidence-based policy options, provide technical support to countries, and monitor and assess health trends. WHO membership includes 194 countries and two associate members.

International Conference on Harmonization

In 1990 the pharmaceutical industries of Europe, Japan, and the United States began to work with drug regulatory authorities with the goal of harmonizing the interpretation and application of technical guidelines and requirements for product registration. Regulatory and pharmaceutical industries benefit from the harmonization as illustrated by the reduction of duplicate clinical trials and minimization of the use of animal testing without compromising safety and effectiveness for drug development. ICH Tripartite Guidelines were developed through scientific consensus with regulatory and industry experts to achieve harmonization.

European Medicines Agency

EMA is responsible for the scientific evaluation of medicines developed by pharmaceutical companies for use in the European Union (EU). This responsibility includes the scientific evaluation of applications for EU marketing authorizations for human and veterinary medicines. Pharmaceutical companies must submit a single marketing authorization application to the Agency and can only start to market a medicine after receiving marketing authorization.

Most of the Agency’s scientific evaluation work is carried out by its scientific committees, which are made up of members from European Economic Area (EEA) countries, as well as representatives of patient, consumer, and healthcare-professional organizations. Committees are responsible for evaluating the development, assessment, and supervision of medicines in the EU. The Agency constantly monitors the safety of medicines and can take action if information indicates that the benefit–risk balance of a medicine has changed since authorization.

The United States Food and Drug Administration

The US FDA consists of four core functions of the agency: Medical Products and Tobacco, Foods and Veterinary Medicine, Global Regulatory Operations, and Policy and Operations. FDA is tasked with protecting the public health by assuring the safety, effectiveness, quality, and security of human and veterinary drugs, vaccines and other biologic products, medical devices, the nation’s food supply, all cosmetics, dietary supplements, and products that give off radiation Over-the-counter (OTC) and prescription drugs, including generic drugs, are regulated by FDA’s Center for Drug Evaluation and Research (CDER).

Therapeutic Goods Administration

The TGA is part of the Australian Government Department of Health. The TGA is responsible for ensuring that therapeutic goods available for supply in Australia are safe and fit for their intended purpose. The TGA’s overall purpose is to protect public health and safety by regulating therapeutic goods that are either imported into Australia or are manufactured in Australia, or exported from Australia. TGA defines therapeutic goods to include medicines, medical devices, and human blood, blood products, and tissues. The goal of TGA is to ensure access, within a reasonable time frame, to new therapeutic goods. These include goods Australians rely on every day, such as vitamin tablets and sunscreens, as well as goods used to treat serious conditions, such as prescription medicines, vaccines, blood products, and surgical implants.

USDA 9 CFR Animals and Animal Products

The CFR annual edition is the codification of the general and permanent rules published in the Federal Register by the departments and agencies of the federal government. It is divided into 50 titles that represent broad areas subject to federal regulation. CFR Title 9 concerns animals and animal products.

USDA Veterinary Service Memorandum No. 800.65

This memorandum provides guidance on preparing veterinary biological products that use embryonated chicken eggs or chicken tissue as an ingredient. It is meant to assist licensees, permittees, and applicants in meeting the purity and quality requirements in 9 CFR 113.50.

International Pharmaceutical Excipients Council

The IPEC Federation is a source for regulatory and guidance documents critical to the excipient industry. The association serves the interests of producers, distributors, and users of pharmaceutical excipients. IPEC-Americas, composed of finished drug manufacturers, excipient producers, and distributors, is part of a global federation, the IPEC Federation, that brings together excipient manufacturers, distributors, and users from the United States, Europe, Japan, and China to set the bar on quality standards.