Translation of "essai à la bille " (French → English) :

(25) In order to increase transparency in the area of clinical trials, data from a clinical trial should only be submitted in support of a clinical trial application if that clinical trial has been recorded in a publicly accessible and free of charge database which is a primary or partner registry of, or a data provider to, the international clinical trials registry platform of the World Health Organization (WHO ICTRP) .

Regarding Article 114 TFEU, this Regulation harmonises the rules for the conduct of clinical trials in the Union, therefore ensuring the functioning of the internal market in view of the conduct of a clinical trial in several Member States, the acceptability throughout the Union of data generated in a clinical trial and submitted in the application for the authorisation of another clinical trial or of the placing on the market of a medicinal product, and the free movement of medicinal products used in the context of a clinical trial.

In addition, the main characteristics of a clinical trial, the conclusion on Part I of the assessment report for the authorisation of a clinical trial, the decision on the authorisation of a clinical trial, the substantial modification of a clinical trial, and the clinical trial results including reasons for temporary halt and early termination, in general, should not be considered confidential.

13. Believes that the use of non-animal test methods and other risk assessment strategies should be promoted, and that animal testing should be minimised and tests on vertebrates should be undertaken as a last resort; recalls that, in accordance with Directive 2010/63/EU, tests on vertebrate animals must be replaced, restricted or refined; calls, therefore, on the Commission to lay down rules to avoid duplicative testing and to ensure that duplication of tests and studies on vertebrates is prohibited;

EUROPA - EU law and publications - EUR-Lex - EUR-Lex - 32008R0692 - EN - Commission Regulation (EC) No 692/2008 of 18 July 2008 implementing and amending Regulation (EC) No 715/2007 of the European Parliament and of the Council on type-approval of motor vehicles with respect to emissions from light passenger and commercial vehicles (Euro 5 and Euro 6) and on access to vehicle repair and maintenance information (Text with EEA relevance) - COMMISSION REGULATION - (EC) No 692/2008 // of 18 July 2008 // implementing and amending Regulation (EC) No 715/2007 of the European Parliament and of the Council on type-approval of motor vehicles with ...[+++]respect to emissions from light passenger and commercial vehicles (Euro 5 and Euro 6) and on access to vehicle repair and maintenance information // ADMINISTRATIVE PROVISIONS FOR EC TYPE-APPROVAL // Appendix 1 // Verification of conformity of production — First statistical method // Appendix 2 // Verification of conformity of production — Second statistical method // Appendix 3 // MODEL // INFORMATION DOCUMENT No . // Appendix to information document // INFORMATION ON TEST CONDITIONS // Appendix 4 // MODEL OF EC TYPE-APPROVAL CERTIFICATE // (Maximum format: A4 (210 × 297 mm)) // Addendum to EC type-approval certificate No . // concerning the type-approval of a vehicle with regard to emissions and access to vehicle repair and maintenance information according to Regulation (EC) No 715/2007 // Appendix 5 // Vehicle OBD information // Appendix 6 // EC Type –Approval Certification Numbering System // Appendix 7 // IN-SERVICE CONFORMITY // IN-SERVICE CONFORMITY CHECK // STATISTICAL PROCEDURE FOR IN-SERVICE CONFORMITY TESTING // RESPONSIBILITIES FOR IN-SERVICE CONFORMITY // VERIFYING AVERAGE EXHAUST EMISSIONS AT AMBIENT CONDITIONS // (TYPE 1 TEST) // EMISSIONS DATA REQUIRED AT TYPE-APPROVAL FOR ROADWORTHINESS PURPOSES // MEASURING CARBON MONOXIDE EMISSION AT IDLING SPEEDS // (TYPE 2 TEST) // MEASUREMENT OF SMOKE OPACITY // VERIFYING EMISSI ...

Research will focus on: developing promising candidate interventions (vaccines, therapies and HIV microbicides) against the target diseases by sponsoring research over the full spectrum from basic molecular research, taking advantage of microbial genomics, through to pre-clinical testing and proof-of-principle; establishing a clinical trials programme to unite and support Europe's clinical trial activities specifically targeted at interventions for use in developing countries; establishing an AIDS Therapy Trials Network in Europe to improve the coherence and complementarity of clinical trials of AIDS therapies for European use.