European Union , submission requirements

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.)... 

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. 

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... 

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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