GLP in the European Union Ecolabel detergents, GLP and accreditation

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1 GLP in the European Union Ecolabel detergents, GLP and accreditation Maik Schmahl Brussels, 25/03/2010 Chemicals Unit

2 Outline What is GLP? How has it developed? The role of the Member States, the European Commission and the OECD Cooperation with European Agencies and regulatory authorities GLP and accreditation: differences and similarities

3 Good Laboratory Practice - Definition: Quality system concerned with the organisational process and the conditions under which non-clinical health and environmental safety studies are planned, performed, monitored, recorded, archived and reported.

4 GLP Objectives: Promote the quality and validity of data generated in the testing of chemicals Protect human health and the environment Facilitate data recognition Avoidance of duplicative testing Animal welfare Time and resource efficiency Avoidance of non-tariff barriers to trade

5 GLP the history 1975 FDA inspections were made at a contract research laboratory (Industrial Biotest Corporation), studies for hundreds of drugs and pesticides Experiments were poorly conceived, carelessly executed or inaccurately analyzed or reported Data fraud: Reporting of observations for animals previously designated as dead or euthanized Pathology summary altered to present more favorable findings Original records were unavailable for review

6 GLP the history Incomplete or absent drug administration records Questionable experience of personnel involved in the studies Original records neither signed or dated Management did not assure critical review of data or proper supervision of personnel

7 GLP - History: 1976 : GLP regulation of FDA on non-clinical laboratory studies 1978 : OECD establishes expert group 1981 : OECD Council Decision on Mutual Acceptance of Data (MAD): GLP-Principles contained in Annex II 1983 : Recommendation concerning compliance monitoring 1987/88 : EU adopts GLP Directives 1989 : OECD Council Decision-Recommendation on Compliance Guides for Compliance Monitoring Procedures for GLP Guidance for the Conduct of Laboratory Inspections and Study Audits 1995 : REVISED GUIDANCE FOR GLP MONITORING AUTHORITIES FOR COMPLIANCE MONITORING PROCEDURES FOR GOOD LABORATORY PRACTICE (GUIDES) + New expert group on GLP - Principles 1997 : Adoption of Revised GLP- Principles 1999 : Amendment of EU GLP Directives following OECD 2004: Codification of GLP Directives

8 GLP in the EC - Legal Framework Directive 2004/10/EC on the harmonisation of laws, regulations and administrative provisions relating to the application of the principles of GLP Directive 2004/9/EC on the inspection and verification of GLP = Codified versions of Directive 87/18 EEC and Directive 88/320/EEC + amendments.

9 GLP in the EC - Legal Framework Internal Market For Chemicals: REGULATION (EC) No 1272/2008 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on classification, labelling and packaging of substances and mixtures (replacing Directive 67/548/EEC (classification, packaging and labelling of chemical substances) and Directive 88/379/EEC (for preparations, as replaced by Dir. 1999/45/EC)) REGULATION (EC) No 1907/2006 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH)

10 GLP in the EC - Legal Framework Internal Market Directives for special chemicals: Medicinal Products (Directive 2001/83/EC amended by 2003/63/EC) Veterinary Medicinal Products (Directive 2001/82/EC ) Plant Protection Products (91/414/EEC) Biocides (98/8/EC) Feed Additives (Regulation 429/2008: detailed rules for 1831/2003) Food Additives (89/397/EEC GLP required in guidance) Cosmetics (76/768/EEC, 93/35/EEC as amended)

11 GLP: Role of the Member States Article 3.1 of Directive 2004/10/EC: Member States shall adopt the measures necessary for verification of compliance with the principles of good laboratory practice. These measures shall include, in particular, inspections and study checks in accordance with the recommendations of the OECD in this area.

12 Some statistics (2006) Laboratories in EU Member State programmes Austria 16 Belgium 16 Czech Rep. 15 Denmark 27 Finland 13 France 118 Germany 163 Greece 6 Hungary 39 Ireland 5 Italy 97 (including 42 efficacy-residue study sites) Netherlands 29 Poland 6 Portugal 7 Romania 6 (no MJV yet!) Slovakia 25 Slovenia 2 Spain 57 Sweden 14 United Kingdom

13 GLP in the EU - Practicalities Role of the Commission inside the EU: ensure uniform application of the GLP principles and compliance monitoring in all Member States facilitate acceptance of data among MS

14 GLP - Role of the Commission inside the EU What we do to achieve this: Regular meetings of Member State experts in the Working Group on Good Laboratory Practice Management of lists of inspected laboratories (CIRCA website) Build up contacts between receiving authorities and monitoring authorities (e.g. EMEA, ECHA) Specific exercises for confidence building: evaluation visits

15 The GLP web site

16 The password-protected CIRCA web site

17 GLP in the EU - Foreign Relations Role of the Commission outside the EU: supplement and co-ordinate views of MS in international fora (OECD) correct application of MAD Decision between EU and other OECD countries acceptance of data through formal agreements on Mutual Recognition (MRA) (Japan, Switzerland, Israel)

18 GLP in the EU - Foreign Relations OECD: The OECD Principles of GLP are an integral part of the 1981 Council Decision on the Mutual Acceptance of Data in the Assessment of Chemicals (revised 1997) Countries can have confidence in the quality and rigour of safety tests

19 OECD Non member-countries: South Africa, Slovenia, Israel and Singapore are full adherents to Council Acts on Mutual Acceptance of Data. Non-clinical safety data must be accepted by OECD and adhering countries

20 OECD More non-member economies to join : Period of provisional adherence began in 2007 (India, Argentina and Brazil) and 2008 (Malaysia) Provisional adherents will accept data from OECD member countries and other adhering economies while they establish GLP compliance monitoring programme Next: China?

21 Relevant agencies European Medicines Agency (EMA) ECHA (European Chemicals Agency) EFSA (European Food Safety Authority)

22 Example: EMEA GLP Inspections for CPMP (Centralised Procedure) : 2 GLP Inspection Requests by CPMP : 6 GLP Inspection Requests by CHMP study audits GLP Inspection Requests by CHMP study audits 9 Marketing Authorisation Applications for medicines for human use 9 Test facilities, 2 in EU, 4 in Canada, 3 in Non-OECD 41 studies audited Inspection duration of 3 6 days 29 studies so far found to be GLP compliant 12 studies found to be not compliant with GLP (in full or partially)

23 GLP and the eco-label for detergents For example: Commission Decision 2003/31/EC establishing revised ecological criteria for the award of the Community eco-label to detergents for dishwashers Annex, Chapter on Assessment and verification requirements: Where possible, the testing should be performed by laboratories that meet the general requirements of EN ISO or equivalent

24 GLP vs ISO Laboratory accreditation addresses and underwrites the technical competence of a laboratory to carry out specified determinations on a continuing basis to defined standards. A laboratory accredited according to ISO can be considered to have satisfied many of the GLP requirements. However, certain fundamental requirements of the GLP Principles are not covered by or are less stringent in laboratory accreditation

25 GLP vs ISO Not covered: use of study plans Study Director as a concept More stringent requirements under GLP: recording and reporting of data management of data retained in archives to allow complete reconstruction of a study programme of independent quality assurance including internal audits of every study.

26 Conclusions EC has strong interest in effective and correct implementation of GLP in the Member States and in the world: Necessity for Internal Market High level of protection of Health and Environment GLP is there for you: GLP is there for you: Good co-operation with receiving authorities necessary for the effective and correct implementation of GLP Unnecessary to require laboratories already working under GLP to get ISO accreditation

27 Any questions? Disclaimer : This presentation does not constitute any formal commitment on behalf of the European Commission and represents the views and opinions of its author only.