European submission

Modules II-V and an introductory document. The summaries cover manufacturing and quality control, nonclinical information (including toxicology) and a clinical overview (comparable to the expert report in previous forms of European submissions). 

Two sections of the NDA are markedly different from a European submission. These are the Integrated Efficacy and Safety. In some respects, these... 

Because the older formulation of diclofenac for parenteral injection was approved in the UK decades ago and marketed there continuously since, with ample experience as to its safety and efficacy, the regulatory pathway for approval of the new formulation in that country as an essentially similar product was relatively straightforward. The new formulation was approved and has been marketed in the UK since late 2007 for parenteral use, 75 mg every 12 hours as needed for the treatment of acute moderate to severe pain. This dose, dosing interval, and indication are the same as for the earlier formulation. Other European submissions are planned and our new formulation of injectable diclofenac is currently under clinical development in the USA. Because no injectable diclofenac has previously been approved in the USA, the US clinical development program has been more comprehensive than that in the UK, including clinical trials that have assessed various doses and dose intervals in several pain models and in subjects ranging from healthy normal subjects to post-surgical patients, and patients with renal or hepatic insufficiency. 

In the case of IVDs that require the involvement of a Notified Body, data on performance characteristics, the results of performance evaluation and device certificates issued by the Notified Body must be included in the submission. The Competent Authorities are responsible for entering the following information in a European medical device databank, EUDAMED ... 

The criteria used to identify events that require expedited reporting to European regulatory authorities are shown in Figure 12.6. The maximum time allowed for the submission of an expedited report is 15 days. The clock starts from the time that any... 

A Regulatory Apologia - a Review of Placebo-Controlled Studies in Regulatory Submissions of New-Generation Antidepressants , European Neuropsychopharmacology (2008)... 

EEA (2006c). Annual European Community LRTAP Convention Emission Inventory 1990-2004. Submission to EMEP through the Executive Secretary of the UNECE. EEA Technical Report 8/2006. Copenhagen European Environment Agency. 

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. 

As at 1 November 2004, a total of 106 States and territories had reported data on the licit movement of precursors and 94 Governments had furnished information on licit uses of and requirements for such substances for 2003 (see annex IV for details). In addition, the European Commission has also furnished information representing submissions from all... 

This is a new procedure introduced imder Directive 2004/27/EC. In contrast to the mutual recognition procedure, the decentrahsed procedure applies to products for which the centralised procedure is not mandatory and which are not authorised in any EU Member State. It facilitates the parallel submission to both RMS and CMSs, involvement of the CMS during the national evaluation phase, and parallel granting of national marketing authorisations after the positive finalisation of the European step of the procedure. Some of the finer details of this new procedure established under the new legislation are yet to be confirmed. 

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... 

The European Commission (EC) issued a guidance document on submissions for food additive evaluations in 2001 (2). 

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. 

The MIAME standard defines the minimum information investigators must report for a microarray experiment to be reproduced. The MAGE standard was born partially from MIAME, and the European Bioinformatics Institute used MIAME and MAGE to guide the development of ArrayEx-press, their public genomic data repository (34). Sample annotation lies at the heart of MIAME, underscoring the need to understand as completely as possible the experimental conditions that may influence the microarray data. Many journals that publish microarray data require the submission of MIAME-supportive microarray data to a public genomic data repository as a condition of publication. These typically include submission of protocols species, strains, and sex used for in vivo studies cell line name and culture conditions for in vitro studies, and other relevant information. 

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. 

Once the European Chemicals Agency has received the dossier, it will assign a registration number and a date for the registration and these will be communicated to the manufacturer or importer for future use. The Agency will conduct a completeness check to ensure all the elements required are present. If the dossier is incomplete the Agency will inform the registrant what further information is needed and set deadlines for its submission. 

As already covered, the first batch of review dossiers had to be submitted by 28 March 2004. In theory, all notifiers within that batch should have submitted a dossier. However, several notifiers had advised the European Commission of withdrawal from one or more product types and at the time of writing, the Commission had published three such withdrawal lists. In addition, the experience has been that further notifiers failed to submit dossiers. By the end of the submission period, the received figures compared with the expectations were as follows. 

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