Regulatory Body

Regulatory body is a government agency that protects public health by regulating food, medical, and other health related products. Each country has its own regulatory body. Below are some commonly known agencies:

• Food and Drug Administration (FDA) – United States
• European Medicines Agency (EMA) – European Union
• Health Canada – Canada

Below is information on the FDA in the United States. Information on EMA is described here xxx link. Health Canada, and other country specific regulatory body may be found through the internet or other resources.

Food and Drug Administration (FDA)

Food and Drug Administration (FDA) is the regulatory agency that oversees food and health related products in the United States. FDA is organized into different offices and centers. The specific organizational chart can be found on FDA’s website at http://www.fda.gov/AboutFDA/CentersOffices/OrganizationCharts/ucm2006146.htm

Relevant Centers for Clinical Trial

For clinical trial in human subjects, there are three centers that are of importance.

1. Center for Biologics Evaluation and Research (CBER)

CBER regulates biological products for human use. Biological products are categorized into

• Blood & blood products
• Cellular & gene therapy products
• Tissue & tissue products
• Vaccines
• Xenotransplantation

2. Center For Drug Evaluation And Research (CDER)

CDER regulates drugs to ensure safety and efficacy to public health. Some of the products regulated by CDER include:

•  Over-the-counter drugs
• Prescription drugs, including biological therapeutics (proteins, antibodies, etc.) and generic drugs
• Other medical products (fluoride toothpaste, antiperspirants, dandruff shampoos, sunscreens, etc.)

3. Center for Devices and Radiological Health (CDRH)

CDRH regulates medical devices, in-vitro diagnostics, and radiation emitting products such as lasers, x-ray systems, cellular phones, and microwave ovens.

Product Approval Process

Majority of the products regulated by the FDA will need to go through the review process as followed:

• Pre-meeting between product manufacturer and FDA to discuss background information (is not required, but can help establish communication)
• Manufacturer submits an application and all supporting information to begin human testing
• FDA reviews the application – 30 days clinical hold
• If the manufacturer does not receive a response from the FDA within 30 days from the date of application submission, the clinical trial may start
• Manufacturer must report to FDA annually to update the status of clinical testing through different phases
• If the results of the clinical testing show efficacy and safety, the manufacturer may submit an application for sale and marketing approval to the FDA
• FDA reviews the application. During the review, FDA may:

1. Ask for more information from the manufacturer
2. Hold advisory committee meeting to get outside expert advice
3. Inspect the production facility where the product will be made

• FDA approves or does not approve the product

Exception to the Product Approval Process

Exceptions to the product approval process above may be in cases such as:

• Accelerated approval program that allows earlier approval of drugs that treat serious diseases and fill an unmet medical need
• Humanitarian use device exemption for device that is intended to treat or diagnose a disease that affects fewer than 4,000 individuals per year
• A 510k review process for low risk medical devices

Post Market Surveillance

Due to the limited number of human subjects that a product can be tested on during the clinical testing process, post market surveillance is critical to monitor safety issues of the product after approval. Manufacturer is required to submit periodic safety updates to FDA. FDA also has an online system called “MedWatch” where physicians and consumers can report safety issues directly to FDA. The safety issues reported may be added to product’s labeling to keep the public informed. In rare cases where significant safety issues are seen, the product use may be severely limited or the FDA may request that the product be withdrawn from the market.

Related pages

1. Clinical Trial Site
2. Contract Research Organization (CRO)
3. Institutional Review Board (IRB) or Ethics Review Committee (ERC)
4. Site Management Organization (SMO)
5. Sponsor