Beyond the EU: DORA and NIS 2 Directive's Global Impact
Seven Steps to Product Approval
1.
2. •Complex!
•Only 1 in 20,000 chemicals goes to the farm from the lab
• Only 1 in 200 makes it through pre-clinical testing and approval
• It can take 4 years to license an animal drug
• It can take 10+ years to take an animal drug from discovery to
approval
• In the past few years, the industry has spent over $400 million,
double what was spent 10 years ago
3. • Animal health products go through preliminary trials
• Tests conducted in test tubes
• Simple organisms are used like bacteria, mold, and yeast
4. • Tests are performed on animals to estimate dosage and check for
adverse effects
• If the trial is a success, the FDA is notified
• The FDA then approves further trials on drugs and food additives
• The USDA reviews plans for vaccines or other animal biologicals
• The EPA issues permits for some experiments
5. • Ensures the safety and effectiveness of the product
• Scientists work closely with manufacturers to make sure that all
necessary tests are being conducted
• Researchers conduct field trials to demonstrate how the product
works under normal conditions
• The manufacturer has to prove that it has produced a quality
product
6. • Tests are reviewed by the appropriate regulatory agency
• If the product is proven safe and effective, the government will
give the manufacturer permission to make and sell the product
7. • When the product is approved, its label becomes part of the
federal record
• The label cannot be changed without government approval
8. • As a final check, the government monitors the food supply for
illegal drug residues
• Random tests are conducted by the FDA, USDA, and FSIS
• The rate of violation has declined in the last 10 years
• Only 0.3% of samples have tested at illegal levels in the last few
years