Regulating Animal Drugs Mrs Brandi Robinson Office of

Regulating Animal Drugs Mrs. Brandi Robinson Office 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

Defining Animal Drugs n 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

Approved Animal Drug • • 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.

• • Areas of Review Human Food Safety • Toxicology • Residue Chemistry • Microbial Food Safety Target Animal Safety Effectiveness Manufacturing Chemistry Environmental Impact Labeling All Other Information

Defining Effectiveness • Example: Based on substantial evidence consisting of one or more adequate and wellcontrolled 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 Safety • 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.

Safety may include: • • Target Animal Safety Human Food Safety Environmental Impact User Safety

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

Human Food Safety • Toxicology • Residue Chemistry • Microbial Food Safety • Regulatory Method

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

User Safety • • • 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

Manufacturing Chemistry Determines whether an animal drug will have and maintain the necessary quality, strength, purity, and identity • Methods and controls • Stability data • GMP compliance

Labeling • Immediate container (vial, syringe, packet) or feed bag labels • Package insert • Packaging (box, carton)

All Other Information • Foreign marketing experience • Reports of pilot studies • Literature reports

Example Approval Process: The United States Approach • • 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 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

Additional Videos on Animal Drug Regulation Available Thank you!