Expert Reports

Overviews / Summaries of Quality Non-Clinical and Clinical Expert Reports I c... 

The requirements for the contents of an application dossier are set out in Annex I of Directive 2001/82/EC. The dossier should be assembled in four parts, as outlined in Figure 7.6. The application form. Summary of Product Characteristics (SPC) and labelling, expert reports and quality sections are quite similar in content to human... 

In volumes 220, 223, 229, and 232 several experts reported on the recent progress of phosphorus chemistry in many fields. This chemistry is so rich, so diversified, that a new volume appeared to be necessary in order to cover some other aspects of such a topic and to point out the key role played by this element. 

Strength of recommendation A based on a meta-analysis or at least one randomized controlled trial. Strength of recommendation B based on at least one well-designed study, including case control and comparative studies. Strength of recommendation C based on expert reports or opinion (levels of evidence and strength of recommendation. Oxford (UK) Centre for Evidence-Based Medicine. Available at http //www.cebm.net/levels of evidence.asp (accessed December 8,2008). 

The Expert Report is a particular requirement of the European pharmaceutical regulatory system. It is intended that the Expert Report submitted by the applicant should include an accurate summary of the supporting evidence for the application and that it should also include a critical discussion of that information. Expert reports were originally required when a requirement for an Assessment Report was imposed on the member states the intention was that the Expert Report should form the basis for that Assessment Report. 

The pharmaceutical part of the Expert Report is expected to include a discussion of the following points (which suggests that the list above is intended to cover the same material) ... 

An examination of the draft formats for the data summaries in the pharmaceutical Expert Report gives some additional insight into the nature of the required discussion. 

OECD Nuclear Energy Agency., Dosimetry Aspects of Exposure to Radon and Thoron Daughter Products. Expert Report, Paris September (1983). 

NEA Experts Report, Dosimetry aspects of exposure to radon and thoron daughter products, OECD-NEA (1983)... 

Dayan AD Rifaximin (Normix ) Preclinical Expert Report. London, submitted to Medicines and Healthcare Products Regulatory Agency, 1997. 

Potentially it may be useful to have an expert report to collect, summarise and evaluate all the available literature data and in-house studies to get an overall view of the toxicity, environmental fate or ecotoxicity of a substance. A simple expert report would be on a single hazardous property, such as toxicokinetics or long-term general toxicity, and in effect would be a review article. 

It is not the intention of this contribution to discuss phenomena that have already been expertly reported in the literature, but to create an insight into everyday polyester production that is a consequence of long years of industrial experience. For detailed mechanistic, chemical and analytical reports, readers may want to refer to a number of excellent reviews available in the literature. 

Part lA Administrative data, packaging, samples Part IB SPC, package leaflets Part IC Expert reports... 

Part IC is divided into three subparts Parts ICl, IC2, and ICS, containing expert reports in prescribed format. 

Part ICl contains an expert report on the chemical, pharmaceutical, and biological documentation. Topics presented include composition, method of preparation, control of starting materials, control tests on intermediate products, control tests on hnished product, stability, and information on the pharmaceutical expert. An example is given in Exhibit 8.5. 

Exhibit 8.5 Expert Report on the Chemical, Pharmaceutical, and Biological Documentation... 

Exhibit 8.6 Expert Report on the Toxicopharmacological (Preclinical) Documentation... 

Content of the DMF Restricted Part (Expert Report), Confidential Applicants Part (Expert Report), Nonconfidential... 

Refer to Section 8.3.2. Note the requirement for the Qualified Person and Expert Reports in Europe. There are no separate applications in the Centralized Procedure for small and large molecule drugs. 

Part I was a summary of the information presented in the whole dossier and included the application forms and administrative particulars on fees, various declarations and the t)rpe of application as well as particulars of the marketing authorisation (lA), proposed SPC (IBl), proposals for packaging, labels and package or patient information leaflets (IB2), and any SPCs already approved in the Member State(s) for the particular product (IB3). Also included were separate Expert Reports on chemical and pharmaceutical (ICl), pharmacotoxicological (preclinical) (IC2), and chnical documentations (IC3), as... 

CTD consists of four modules, preceded by a Module 1 that is region-specific and includes administrative and prescribing information. Module 2 comprises of CTD summaries and overviews of the quality, non-clinical and clinical data. Module 3 contains data on quality. Module 4 consists of the non-clinical study reports and Module 5 comprises the clinical study reports. There are guidelines on the details to be included in each module and these are summarised in Box 17.2. The non-clinical and clinical overviews and summaries are equivalent to the previous Expert Reports submitted under sections IC2 and IC3 respectively of part I, data. 

In all cases, an Expert Report (or its CTD equivalent, the Clinical Overview), which is a critical analysis of the proposed availability of the product without a medical prescription with the dose and indications as stated in the application, must be provided. The expert is expected to take a clear position, defend the proposal in light of current scientific knowledge, and demonstrate why none of the criteria that determine classification for supply subject to a medical prescription applies to the product. 

Dr Yoshinobu Hirayama, Director, Evaluation Division 1, of the MHW Pharmaceuticals and Medical Devices Evaluation Centre confirmed that the current GAIYO (Expert Report) will be replaced by CTD Module II documents. He cautioned, however, that although the CTD provides a common content and format, there will be cases where differences would necessarily occur in dossiers for the three regions (e.g. there may be different dosage recommendations and different quality requirements). He sympathised its the impact on industry who would feel the burden of transition more than regulators and indicated that the transition time before the CTD... 

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... 

Information about the overseas status of the product was also now sought as part of an application. The list of countries mentioned in this context in the AGRDl included members of the Pharmaceutical Evaluation Report (PER) Scheme, other EC countries and the United States. Expert reports also began to be utilised in the evaluation of applications. 

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