The document discusses various US and European regulatory agencies that oversee different aspects of biotechnology. The FDA regulates food additives and drugs. The EPA regulates genetically modified crops and water quality. The EPA, FDA and USDA regulate environmental releases of genetically engineered organisms. Patents regulate drugs by requiring them to be functional with no malfunctions. New streamlined drug approval processes in Europe have reduced approval times from four years to one. Europe has the most applicants for cancer therapy patents because purification steps are often individually patented. Firms should evaluate all aspects of production after the Fluvirin incident highlighted regulatory issues. ESTs cannot be patented because they only identify genetic locations rather than having a specific utility. Drug approvals take less time in

1. Biotechnology
Regulations
Chapter 12: Essence Perry

2. 1. Regulates Food Additives
The FDA or Food
and Drug Agency is a
U.S agency that
regulates food
additives.

3. 2. Regulates GM crops
The EPA or
Environmental
Protection Agency is
a US government
agency that
regulates genetically
modified crops.

4. 3. Regulates Water Quality
The EPA or
Environmental
Protection Agency is
a US government
agency that regulates
water quality.

5. 4. Environmental Release
The EPA or Environmental
Protection Agency, The FDA
or Food and Drug Agency,
and USDA or US Department
of Agriculture are US
government agencies that
regulate environmental
releases of genetically
engineered organisms.

6. 5. How do patents regulate drugs?
Patents regulates
drugs and devices
because a product
released must be
functional, usable,
and have no
observable
malfunctions.

7. 6. New streamlined processes in
European drug market.
New streamlined
approval processes in
Europe have affected
their drug market
because approvals
that took four year
now take one.

8. 7. Greatest number of patent applicants in
Cancer Therapy.
Europe has the most
applicants of Cancer
Therapy applicants
because every step of
the purification
process is usually
patented.

9. 8.Fluvirin incident and FDA
Firms should evaluate
every aspect of
production; including
people, procedures,
equipment, materials,
record keeping, audits,
and training.

10. 9. Patenting an EST
Patents products should
be nonobvious and have
utility, EST’s are not
products and only
function to identify
location, they do not
qualify as patentable.

11. 10. Drugs at EU and USA
The EMEA has no
knowledge of drug
product until it is
submitted for approval;
therefore a drug will
take a shorter time for
approval.