Mrs. Brandi RobinsonOffice of New Animal Drug Evaluation

Center for Veterinary Medicine

Regulating Animal Drugs

• Protect the Public Health by ensuring • safe and effective animal drugs

reach the market•unsafe and ineffective animal

drugs do not reach the market

Regulating Animal Drugs

Animal drugs are articles intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease in animals and articles intended to affect the structure or any function of the body of the animal

Defining Animal Drugs

• The product is safe and effective for its intended use.

• The methods, facilities and controls used for the manufacturing, processing and packaging of the drug are adequate to preserve its identity, strength, quality and purity.

Approved Animal Drug

• Human Food Safety

• Toxicology• Residue Chemistry• Microbial Food Safety

• Target Animal Safety

• Effectiveness

• Manufacturing Chemistry

• Environmental Impact

• Labeling

• All Other Information

Areas of Review

• Example: Based on substantial evidence consisting of one or more adequate and well-controlled investigations such as –

• a study in a target species• a study in laboratory animals• any field investigation• a bioequivalence study• an in vitro study

Defining Effectiveness

• Example: Adequate tests by all methods reasonably applicable show that the drug is safe for use under the conditions prescribed, recommended, or suggested in the proposed labeling.

Defining Safety

Safety may include:

• Target Animal Safety

• Human Food Safety

• Environmental Impact

• User Safety

Safety

• The cumulative effect of the drug on the animal(s), such that the drug does not adversely affect the treated animal(s)

Target Animal Safety

• Toxicology

• Residue Chemistry

• Microbial Food Safety

• Regulatory Method

Human Food Safety

• Use, manufacture and disposal does not pose a significant environmental impact

Environmental Impact

• Hazards associated with administration to animals

• Hazards associated with manufacturing • Direct - occupational exposure at

site• Indirect - manufacturing emissions

• Hazards associated with use of air, water and solid wastes contaminated via use and disposal of the drug

User Safety

Determines whether an animal drug will have and maintain the necessary quality, strength, purity, and identity

• Methods and controls

• Stability data

• GMP compliance

Manufacturing Chemistry

• Immediate container (vial, syringe, packet) or feed bag labels

• Package insert

• Packaging (box, carton)

Labeling

• Foreign marketing experience

• Reports of pilot studies

• Literature reports

All Other Information

• Pre-submission conference - formal process• Sponsor and CVM may discuss and voluntarily

agree on

• Product Development Plan• General design for each study or use of a

standard protocol

• CVM provides guidance documents for various studies

• Simultaneous work under each area of review

Example Approval Process:The United States Approach

• Sponsor conducts studies to generate data following protocol concurrence

• Data is evaluated by sponsor and CVM for quality assurance (data integrity)

• Data is scientifically reviewed by CVM

• CVM determines if study is acceptable (pivotal) for making safety or effectiveness decision

Example Approval Process:The United States Approach

• NADA is a systematic approach to document evidence that drug products are safe and effective

• Approved drug product consists of the drug, the packaging and the labeling

Example Approval Process:The United States Approach

• CVM describes the documented evidence in a Freedom of Information Summary, an Environmental Assessment, and in drug labeling.

• Codifies the approval in the CFR via a Federal Register announcement.

• All are accessible by the public

Example Approval Process:The United States Approach

• Protect the Public Health by ensuring • safe and effective new animal

drugs reach the market•unsafe and ineffective new animal

drugs do not reach the market• Work efficiently to process and

review sponsor submissions and applications

• Work within the limits of statutory authority

Example Approval Process:The United States Approach

Thank you!

Additional Videos on Animal Drug

Regulation Available