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IDRG
International Development of Regulatory Globalization
GLOBAL REGISTRATION of BIOPESTICIDES:
A SYMPHONYImme Gerke, PhD
Global Regulatory Strategist
IDRG
International Development of Regulatory Globalization
TAKING A LEAP OF FAITH
Public Land Public Health
FiberFeed
Food10,000
Growers
ScientistsRegistrants
Regulators
• growers• marketers• processors• landscapers• exterminators• ……
• chemists• biologists• agronomists• engineers• toxicologists• ecologists• ……
• research• business• finance• marketing• legal• production• quality control• commercialization• ……
• compliance• coordination• chemistry/physics• toxicology (human)• toxicology (env.)• exposure• env. fate• value• policy• …… > 200 countries
nationally
regionally
globally
THE PEOPLE
SYMPHONY
IDRG
International Development of Regulatory Globalization
‘The director is the only musician who makes no sound.’ (Benjamin Zander)
SONG SHEET
IDRG
International Development of Regulatory Globalization
guidelines
data requirements
presubmission consultations
study protocols
submission templates
format
review templates
uniform principles
GUIDELINES
IDRG
International Development of Regulatory Globalization
DATA REQUIREMENTS
IDRG
International Development of Regulatory Globalization
PRESUBMISSION CONSULTATION
IDRG
International Development of Regulatory Globalization
many countries
electronic and/or face-to-face
free or fee
proposed workshares and joint reviews allow regulators to harmonize further
resolve differences prior to reaching the market
application• request form• product specification form• list of uses• draft label/use pattern
PRESUBMISSION CONSULTATION
IDRG
International Development of Regulatory Globalization
CROP PESTALMONDS EMPOASCA LYBICAAPRICOTS EMPOASCA LYBICAPLUMS-EUROPEAN EMPOASCA LYBICAPEACHES EMPOASCA LYBICAGRAPES: GENERAL EMPOASCA LYBICACHERRIES EMPOASCA LYBICANECTARINES EMPOASCA LYBICACOTTON BEMISIA TABACICUCUMBERS BEMISIA TABACI
EGGPLANT/AUBERGINE BEMISIA TABACI
MELON BEMISIA TABACIPEPPER-BELL/SWEET BEMISIA TABACISQUASH-BUTTERNUT BEMISIA TABACITOMATOES BEMISIA TABACIWATERMELONS BEMISIA TABACISTRAWBERRIES HEMIPTERA
PRESUBMISSION CONSULTATION
IDRG
International Development of Regulatory Globalization
STUDY PROTOCOLS
IDRG
International Development of Regulatory Globalization
SUBMISSION TEMPLATES
IDRG
International Development of Regulatory Globalization
SUBMISSION FORMAT
IDRG
International Development of Regulatory Globalization
REVIEW TEMPLATES
IDRG
International Development of Regulatory Globalization
UNIFORM PRINCIPLES
IDRG
International Development of Regulatory Globalization
FEES & TIMELINES
IDRG
International Development of Regulatory Globalization
“Fees and timelines vary widely.”
We need to check our assumptions.
Fees are calculated in different ways: by study to be reviewed, by submission type, by MRL, by maintenance fee, with fee reduction programs … or are effected by exchange rates.
Timelines in Canada appear to be longer than in the US but therefore there is no waiting time to get onto a schedule.
The EU reviews AI and EP successively while NA reviews simultaneously but therefore the individual intervals are shorter.
OECD
GLOBAL DATABASE OF REGISTERED PRODUCTS AND USES
…(North American
Counties)
…(Central American
Countries)
...(AfricanCountries)
...(South American Countries)
…(Australia)
...(Asian Countries)
PRODUCTSGlobal
IDRG
International Development of Regulatory Globalization
...(Eurasian Countries)
...(European Countries)
GLOBAL NEEDS DATABASE
PMC(Canada)
IR4(USA)
MUN(Great Britain)
...(AfricanCountries)
...(South American Countries)
MULO(Australia)
...(Asian Countries)
...(European Countries)
NEEDSGlobal
IDRG
International Development of Regulatory Globalization
DISCUSSION
?!
IDRG
International Development of Regulatory Globalization
