IDRG International Development of Regulatory Globalization GLOBAL REGISTRATION of BIOPESTICIDES: A...

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