European Union , submission

The Board transmits form D, an annual questionnaire on substances frequently used in the illicit manufacture of narcotic drugs and psychotropic substances, to all Governments. As at 1 November 2004, a total of 135 States and territories, as well as the European Commission on behalf of the States members of the European Union, had submitted form D for 2003 (see annex II for details). With 66 per cent of all States parties and 48 per cent of non-parties submitting data for 2003, the rate of submission for 2003 is approximately the same as that of previous years. 

The FDA has clarified the minimum requirements for an IND submission in three areas chemistry, toxicology reports (draft) and size (2-3 volumes, each 3" thick) in an attempt to relax current practices somewhat, to the level required for a UK CTX. However, full reports are to be provided within a short time after the initial drafts. (Conversely, however, information needed to conduct human studies in the European Union has increased, recently, with the implementation of the Clinical Trial Directive.)... 

The NDA is a layered document. There are summary documents, individual study reports and actual data tabulations. It differs in two main ways from the dossier submitted in the European Union (1) in the amount of raw data contained in the NDA submission, and (2) in the presence of expert reports in the European dossier, compared with well defined integrated summaries in the NDA. This resulted from historical, cultural... 

This essay reviews the submission requirements for the four markets of greatest interest to American companies Canada, Australia, Japan, and the European Union (EU). Finally, the latest update on the International Conference on Flarmonization (ICFI) and attempts at harmonization is included. 

Toxicity and environmental concerns led to submission of a proposal to European Union to ban the use of PBDPE in 1989 (111-4301-89-EN Draft). The proposal was rejected on the basis of recommendations issued by a thorough debate between scientists, regulators, producers, and users of fire retardants, stating that banning would involve an unacceptable fire risk since alternatives were not available to replace halogen-based fire retardants with comparable effectiveness. Ever since, fire-retardant research has been mostly devoted to the development of nonhalogenated replacements for the halogen fire retardants. 

Centralized Procedure (CP) This is the procedure of most interest for biopharmaceuticals, as this is the mandatory route for review and approval of such drugs in the European Union. In the centralized procedure a single application is submitted to the European Medicines Agency (EMEA). A variety of presubmission activities, starting six months before the intended start date of the centralized procedure, are required [8], Two initial assessments by a Rapporteur and Co-rapporteur national authorities (one from each of two member states chosen by the EMEA) are made, leading to Day 80 Critical Assessment Reports. A consolidated list of questions (LoQ) is provided to the applicant at Day 120 when there is a clock stop, normally of three months, to allow the preparation and submission of responses. Following satisfactory negotiation of other steps in the procedure, the Committee on Human Medicinal Products will recommend authorization at Day 210, with authorization by the Commission at Day 277. 

As at 1 November 2006, a total of 107 States and territories had reported data on the licit movement of precursors and 96 Governments had furnished information on licit uses of and requirements for such substances for 2005 (see annex IV for details). As in previous years, the European Commission has furnished information representing submissions from all 25 States members of the European Union. Most States and territories submitting form D are also able to furnish data on the licit movement of some precursor chemicals. 

Safety testing of chemicals is required under several directives of the European Union (EU) and international regulatory environments.1 Each of these legislative mandates requires submission of sound... 

Many countries with strong interests in chemicals, pesticides and pharmaceuticals and their trade started subsequently to adopt the OECD Principles of Good Laboratory Practice as the basis for safety testing in their industries. The European Union (then still named the European Community) also, by the Council Directive 67/18/EEC of 18 December 1986, formally adopted the OECD Principles, including them within its framework of guidelines governing the submission of safety data for the marketing of chemical substances. 

The first OECD HPV chemicals list was compiled in 2000, containing 5235 substances and is based on the submissions of nine national inventories and that of the European Union. A further list was compiled in 2003 (available at http //www.oecd.org/EN/document/0 EN-document-525-14-no-l-9998-0,00.html). The OECD Integrated HPV Database is available at the same website. 

In contrast with the European Union, where the premarketing scheme requires the submission of base sets of test data in relation to the production volumes of the new chemicals, the TSCA does not require that submitters conduct testing prior to the submission of the notification to the EPA, Under... 

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