Regulatory Information

The pharmaceutical industry is heavily regulated. New drugs must undergo intense scrutiny by regulatory authorities (FDA in the U.S., EMEA in the European Union, and the Ministry of Health and Welfare in Japan) before they may be shipped and sold on the market. By understanding and taking into account the regulatory considerations in getting a new drug approved, you can design a plan that minimizes the problems in preclinical and clinical testing.


Good Laboratory Practice (GLP)

Preclinical safety studies must be performed in compliance with Good Laboratory Practices (GLP) regulations as detailed in 21 CFR Part 58. The GLPs clearly define the roles and responsibilities of the study Sponsor as well as of the Study Director, Quality Assurance Unit, and Management at the testing laboratory. They require thorough documentation of all phases of a preclinical study. A key feature of GLP treatment is the role of the QAU in monitoring the conduct of the study and inspecting study data and the final report.

Investigational New Drug (IND) Application

21 CFR Part 312 details the requirements for an Investigational New Drug application. The IND application is a request to the FDA to allow for experimental testing of the drug with human volunteers and patients who have the disease under study.

Good Manufacturing Practice (GMP), Current Good Manufacturing Practice (cGMP)
U.S. pharmaceuticals must be manufactured under current Good Manufacturing Practice (cGMP) conditions as specified in CFR Title 21, Parts 210, 211, and 600. Process validation, equipment qualification, quality assurance, quality control, and documentation are vital in satisfying these requirements. Documented standard operating procedures (SOPs) must be used to assure consistency in the manufacturing process. With some minor exceptions, cGMPs must also be followed in manufacturing samples for clinical trials.


To harmonize worldwide requirements concerning preclinical safety studies during the drug development process, FDA and the ICH have released a series of guidelines covering the nature and timing of preclinical safety and efficacy studies for new drug entities. Because animal safety studies and human clinical trials should be approached from the most scientifically and ethically appropriate standpoint for the particular pharmaceutical agent under development, the guidelines are not to be construed as rigid requirements. Rather, they were designed to provide general guidance for conducting these studies. Certain drugs deserve a case-by-case approach designed to expedite or optimize development—for example, biotechnology-derived therapeutics or drugs for life-threatening diseases for which no treatments currently exist.

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