FUTURE ISSUES INCLUDING BROADENING THE SCOPE OF THE GLP PRINCIPLES Francisca E. Liem U.S. Environmental Protection Agency 1200 Pennsylvania Ave, NW 2225A Washington, DC 20460 OECD Event, Event, Villa Tuscolana, Tuscolana, Frascati (Roma), Italy, Italy, April 10 – 11, 2008 MILESTONES OF THE GLPS OECD 1982 OECD Principles of GLP 1997 OECD Principles of GLP (Revised) OECD Event, Event, Villa Tuscolana, Tuscolana, Frascati (Roma), Italy, Italy, April 10 – 11, 2008 ELECTRONIC DATA AND RECORD KEEPING OECD Event, Event, Villa Tuscolana, Tuscolana, Frascati (Roma), Italy, Italy, April 10 – 11, 2008 OECD GUIDANCE DOCUMENT NO. 10 The Application of the OECD Principles of GLP to Computerized Systems OECD Event, Event, Villa Tuscolana, Tuscolana, Frascati (Roma), Italy, Italy, April 10 – 11, 2008 U.S. ENVIRONMENTAL PROTECTION AGENCY Cross Media Electronic Reporting and Record Keeping Rule CROMERRR August 31, 2001 – Draft rules on Electronic Reporting and Record Keeping (Cross Media Electronic Reporting and Record Keeping Rule - CROMERRR) October 13, 2005 – Final rule on Electronic Reporting (Cross Media Electronic Rule – CROMERR) OECD Event, Event, Villa Tuscolana, Tuscolana, Frascati (Roma), Italy, Italy, April 10 – 11, 2008 UNITED STATES FOOD AND DRUG ADMINISTRATION (FDA) 21 CFR Part 11 OECD Event, Event, Villa Tuscolana, Tuscolana, Frascati (Roma), Italy, Italy, April 10 – 11, 2008 UNITED STATES OF AMERICA FEDERAL INFORMATION PROCESSING STANDARDS (FIPS) • FIPS 186-2 – Jan 2002 – Digital Signature Standard • FIPS 186-3 – Mar 2006 – Digital Signature Standard (Draft) • FIPS 186-3 – Dec 2007 – RSA Strong Primes – Digital Signature Standard (Draft) • FIPS 190 – Guideline for the Use of Advanced Authentication Technology Alternatives OECD Event, Event, Villa Tuscolana, Tuscolana, Frascati (Roma), Italy, Italy, April 10 – 11, 2008 NON-CONVENTIAL PESTICIDE PRODUCTS REGISTRATION REQUIREMENTS • Biological/microbiological pesticides • Biocides • Public health pesticides – Insecticides – Rodenticides – Avicides • Biotechnology – Genetically Modified Organisms (GMO) – Plant Incorporated Protectants (PIP) OECD Event, Event, Villa Tuscolana, Tuscolana, Frascati (Roma), Italy, Italy, April 10 – 11, 2008 INDUSTRIAL CHEMICALS Existing chemicals Europe – REACH USA – Test Rule New chemicals Europe - REACH USA – Consent Testing Agreement Fuel additives Nanotechnology OECD Event, Event, Villa Tuscolana, Tuscolana, Frascati (Roma), Italy, Italy, April 10 – 11, 2008 OTHER GLP COMPLIANCE ISSUES • Registration dossier – – – – Cited old data (prior 1982) Cited scientific papers/publications Data developed in non-GLP countries Human testing OECD Event, Event, Villa Tuscolana, Tuscolana, Frascati (Roma), Italy, Italy, April 10 – 11, 2008 ARE WE READY? OECD Event, Event, Villa Tuscolana, Tuscolana, Frascati (Roma), Italy, Italy, April 10 – 11, 2008 MUTUAL ACCEPTANCE OF DATA (MAD) • Global economy • Reliance on other countries’ developed data – Laboratory studies – Field studies OECD Event, Event, Villa Tuscolana, Tuscolana, Frascati (Roma), Italy, Italy, April 10 – 11, 2008 MUTUAL ACCEPTANCE OF DATA OECD COUNCIL ACTS ON MAD • 1981 • 1989 • 1997 Council decision on MAD in the Assessment of Chemicals Council decision/recommendation on Compliance with Principles of GLP Council decision on Adherence of Non-member Countries to the Council Acts to MAD OECD Event, Event, Villa Tuscolana, Tuscolana, Frascati (Roma), Italy, Italy, April 10 – 11, 2008 MAD – NON OECD MEMBERS • Welcome and encourage • Recognized and accepted by OECD members • Challenges: – Small programs – Small number of test facilities – Experience • Collaboration with major programs OECD Event, Event, Villa Tuscolana, Tuscolana, Frascati (Roma), Italy, Italy, April 10 – 11, 2008 OTHER CHALLENGES FOR GLP MONITORING AUTHORITIES • More trust in test facilities that have been inspected – Slow down, less vigilant? • May result in data quality and integrity problems as <1981 • Do more with less resources – Change approach by MA • Calendar based inspections • Risk based inspections – More facility inspections, less data audits – Out-source inspections (Third Party) OECD Event, Event, Villa Tuscolana, Tuscolana, Frascati (Roma), Italy, Italy, April 10 – 11, 2008 MONITORING AUTHORITY MORE VIGILANT INSTEAD OF LESS • Initiate inspection program of new types of products (non-conventional pesticide/chemical products) • Train compliance and enforcement workers – Science of the study – Inspections of new types of product • Change of workforce – Backfill – Expand workforce OECD Event, Event, Villa Tuscolana, Tuscolana, Frascati (Roma), Italy, Italy, April 10 – 11, 2008 INTERNATIONAL CHALLENGES FOR OECD MEMBERS • Harmonization of inspections of new types of products • Harmonization of application of Principles • Dissemination of new procedures/policies to the regulated community • More resources needed – Financial – Human • More flexible? OECD Event, Event, Villa Tuscolana, Tuscolana, Frascati (Roma), Italy, Italy, April 10 – 11, 2008 INTERNATIONAL CHALLENGES FOR OECD MAD MEMBERS • More reliance on other countries Monitoring Authorities • More communication needed between and among MAD members • OECD countries that do not have an official GLP Monitoring program • Registration requirements are not yet harmonized OECD Event, Event, Villa Tuscolana, Tuscolana, Frascati (Roma), Italy, Italy, April 10 – 11, 2008 IN SPITE OF CHALLENGES TO MONITORING AUTHORITIES We have come a long way since 1981 OECD Event, Event, Villa Tuscolana, Tuscolana, Frascati (Roma), Italy, Italy, April 10 – 11, 2008 E T I G THHEE T THHEE T HEE T H TH E CORDINNG TOO C A G TO W O RLD TO WO W G LPP L G LP G G LP T H T THHEE WWOORRLD GGLLPPP G GLLP ORD G T O WWOORRLLD AACCC CORD ING T O P GLLP O C R C DIN A O C R C D D A I O C L R NGG T C D D A I L R O C N R C D DIN G T O ORD OORRRLLDD AACCC WWWOO RLLDD AACCCOORRDDIININNGGGTTTOOO OECD Event, Event, Villa Tuscolana, Tuscolana, Frascati (Roma), Italy, Italy, April 10 – 11, 2008 Brazil India China Argentina Chinese Taipei Singapore Turkey Thailand Malaysia OECD Event, Event, Villa Tuscolana, Tuscolana, Frascati (Roma), Italy, Italy, April 10 – 11, 2008 IN SPITE OF CHALLENGES TO MONITORING AUTHORITIES • We have come a long way since 1981 – Better quality of data – Better quality of final reports – Reconstruction of data – Better data integrity • Harmonization of GLP Monitoring programs • Harmonization of GLP inspections and study audits OECD Event, Event, Villa Tuscolana, Tuscolana, Frascati (Roma), Italy, Italy, April 10 – 11, 2008 SOP s SUMMARY • Technology keeps updating itself • Non conventional products to be tested and registered • Old data and scientific papers • MAD, new Non Members • Other challenges for the future – Compliance monitoring programs – Compliance monitoring authorities – International harmonization OECD Event, Event, Villa Tuscolana, Tuscolana, Frascati (Roma), Italy, Italy, April 10 – 11, 2008 ARE WE READY? OECD Event, Event, Villa Tuscolana, Tuscolana, Frascati (Roma), Italy, Italy, April 10 – 11, 2008 Francisca E. Liem U.S. Environmental Protection Agency 1200 Pennsylvania Ave. NW 2225A Washington, DC 20460 202.564.2365 tel fax 202.564.0029 Liem.francisca@epa.gov OECD Event, Event, Villa Tuscolana, Tuscolana, Frascati (Roma), Italy, Italy, April 10 – 11, 2008