Regulatory Process And Requirements

Chow and Liu (1995a) indicated that the development of a pharmaceutical entity is a lengthy process involving drug discovery, laboratory development, animal studies, clinical trials, and regulatory registration. The drug development can be classified into nonclinical, pre-clinical, and clinical development phases. As indicated by the USA Today (Feb. 3, 1993), approximately 75% of drug development is devoted to clinical development and regulatory registration. In this section we will focus on regulatory process and requirements for clinical development of a pharmaceutical entity.

For marketing approval of pharmaceutical entities, the regulatory process and requirements may vary from country (or region) to country (or region). For example, the European Community (EC), Japan, and the United States have similar but different requirements as to the conduct of clinical trials and the submission, review, and approval of clinical results for pharmaceutical entities. In this section, for simplicity, we will focus on the regulatory process and requirements for the conduct, submission, review, and approval of clinical trials currently adopted in the United States. As was indicated earlier, the FDA was formed in 1931 to enforce the FD&C Act for marketing approval of drugs, biological products, and medical devices. With very few exceptions, since the enactment of the FD&C Act, treatment interventions such as drugs, biological products, and medical devices either currently on the market or still under investigation are the results of a joint effort between the pharmaceutical industry and the FDA. To introduce regulatory process and requirements for marketing approval of drugs, biological products, and medical devices, it is helpful to be familiar with the functional structure of the FDA.

The Food and Drug Administration

The FDA is a subcabinet organization within the Department of Health and Human Services (HHS) which is one of the major cabinets in the United States government. The FDA is headed by a commissioner with several deputy or associate commissioners to assist him or her in various issues such as regulatory affairs, management and operations, health affairs, science, legislative affairs, public affairs, planning and evaluation, and consumer affairs. Under the office of commissioner, there are currently six different centers of various functions for evaluation of food, drugs, and cosmetics. They are Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER), Center for Devices and Radiological Health (CDRH), National Center for Toxicological Research (NCTR), Center for Veterinary Medicine (CVM), and Center for Food Safety and Applied Nutrition (CFSAN).

Recently, in the interest of shortening the review process, the sponsors are required to provide the so-called user's fee for review of submission of applications to the FDA. In October 1995 CDER was reorganized to reflect the challenge of improving efficiency and shortening the review and approval process as demanded by the United States Congress and the pharmaceutical industry. Figure 1.3.1 provides the current structure of CDER at the FDA, which is composed of 10 major offices. These offices include Office of Management, Office of Training and Communications, Office of Compliance, Office of Information Technology, Office of Regulatory Policy, Office of Executive Program, Office of Medical Policy, Office of New Drugs, Office of Pharmaceutical Science, and Office of Pharmacoepidemiology and Statistical Science. The Office of New Drugs is responsible for drug evaluation, which consists of six offices, including Offices of Drug Evaluation I-V and Office of Pedi-atric Drug Development and Program Initiatives. On the other hand, Office of Pharmaceutical Science consists of four offices, including Office of New Drug Chemistry, Office of Generic Drugs, Office of Clinical Pharmacology and Biopharmaceutics, and Office of Testing and Research. Furthermore, CDER recently establishes the Office of Pharmacoepidemiology and Statistical Science in recognition of the importance of epidemiology and statistics in drug evaluation. Office of Pharmacoepidemiology and Statistical Science includes Office of Drug Safety and Office of Biostatistics. Note that each of these offices consists of several divisions. Figures 1.3.2,1.3.3, and 1.3.4 provide respective organizations of Offices of New Drugs, Pharmaceutical Science and Pharmacoepidemiology and Statistical Science. Note that CBER has a similar functional structure though it has fewer offices than CDER.

FDA Regulations for Clinical Trials

For evaluation and marketing approval of drugs, biological products, and medial devices, the sponsors are required to submit substantial evidence of effectiveness and safety accumulated

Drug Regulatory Process
Figure 1.3.1 Center for Drug Evaluation and Research.

Pregnancy Labeling Team (HFD-020)

SandraKweder 301-594-5476 FAX 301-827-0486

Program Management Team (HFD-022)

William Oswald 301-594-5665 FAX 301-827-6707

Office of Drug Evaluation I(HFD-lOl)

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