Initial Project Information: MANSEV
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Macro Medico 		Updated: Jun 3, 97  

MANSEV

Market authorisation by network submission and evaluation

[ Coordinator(s) ] [ Participants ] [ Project Objectives, ... ] [ Other Characteristics ]

Project Nr: HC 1031 Group: VI Project Duration: 24 months
Key words:
Category:Telematics Applications supporting market authorization of pharmaceuticals by network submission and evaluation.
Summary: To improve and accelerate market authorisation process for medicinal products.
Mission:The aim of MANSEV is the design and implementation of a novel electronic submission system adapted to new EU drug regulatory procedures. Using the network infrastructure of the EU regulatory authorities, the system will be designed as an interchange module between pharmaceutical companies and the authorities with whose application tracking facilities it will be integrated. Implemented by means of Internet Web technologies, the project is expected to result in a fully functional pilot system for initially limited verification and, following its completion, possibly extensive use in pharmaceuticals production. MANSEV participates in the project cluster entitled: ACTION for Telematics Applications for Cooperative work of Healthcare Professionals.
URL:

Coordinator(s)

  • Mr. F. Argentesi
    JRC/EI TP 280
    Via E. Fermi
    I-21020 Ispra
    Italy     		tel: 39 332 78 9249
    fax: 39 332 78 9256
    flavio.argentesi@jrc.it
    url:

Participants:

Name of InstitutionCity+Postal CodeCountryRegion
Artificial Intelligence Software I-Milan, 20132 Italy IT2
Bundesinstitut fur Arzneimittel und Medizinprodukte D-Berlin, 13353 Germany DE3
Hoskyns UK-London,W1V 8HH GB UK55
Hoechst D-Frankfurt, 65926 Germany DE71
Janssen B-Beerse, 2340 Belgium BE1
Medicines Control Agency UK-London, SW8 5NQ GB UK55
Agence du Medicament F-Paris, 93200 France FR1
SmithKline & Beecham UK-London, TW8 9ET GB UK55
Zentrum fur Graphische Datenverarbeitung D-Darmstadt, 64283 Germany DE71
Glaxo UK-London, UB6 0HE GB UK55
Pharmacia S-Stockolm, 171 97 Sweden SE01

Project Objectives, Summary Description and Anticipated Results

The objective of the project is the design and implementation of a network based electronic submission system suitable for the European Union new regulatory system. This system will be designed as an interchange module between pharmaceutical companies and regulatory authorities. The integration with the management and evaluation environments (Application Tracking Systems) of the regulatory authorities is the most innovative design feature of MANSEV.
  • The project will be implemented by using internet technologies with particular reference to web technologies based on the HyperText Transfer Protocol and on the HyperText Markup Language document format.
  • The supporting network infrastructure and services will be European Union Drug Regulatory Authorities Network (EudraNet) which is a private internet of the European Agency for the Evaluation of Medicinal Products (EMEA) and the national regulatory authorities prototyped by the Joint Research Centre and developed industrially by the Interchange of Data between Administrations (IDA) programme.The project is fully driven by the two identified user categories, i.e. pharmaceutical companies and regulatory authorities.
  • The anticipated result is a fully functional pilot system for electronic submission supporting transparent integration with the Application Tracking System, developed jointly by the European Agency for the Evaluation of Medicinal Products and Directorate General III (Industry).
  • The pilot system will be verified with a limited number of files covering the different procedures envisaged by the new European Union regulatory system. A full scale demonstration of the system, i.e. its extensive use in the production process is incompatible with the available budget and it will be attempted if possible after the end of this project with the partners own resources.

Other Characteristics of the Project:

Users involved
Technologies and/or approach used
Expected benefits for the citizen
Expected benefits for the users of the application
Expected benefits for the European Industries
Contribution to EU-policies

Validation Sites

European Agency for the Evaluationof Medicinal Products London Greater London UK
Bundesinstitut fur Arzneimittel und Medizinprodukte Berlin Berlin DE
Agence du Médicament Paris Ile de France FR

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