IT PROJEKTY V EU INFORMAČNÍ SYSTÉMY T. ZÍTKOVÁ

Transkript

1 IT PROJEKTY V EU INFORMAČNÍ SYSTÉMY T. ZÍTKOVÁ

2 TATO PREZENTACE JE URČENA POUZE PRO INTRANET VŠCHT. JE CHRÁNĚNA AUTORSKÝMI PRÁVY A JAKÉKOLIV ZVEŘEJNĚNÍ ČI ZNEUŽITÍ BUDE POSUZOVÁNO DLE ZÁKONA Č. 121/2000 SB., O PRÁVU AUTORSKÉM, O PRÁVECH SOUVISEJÍCÍCH S PRÁVEM AUTORSKÝM A O ZMĚNĚ NĚKTERÝCH ZÁKONŮ, VE ZNĚNÍ POZDĚJŠÍCH PŘEDPISŮ. 2

3 EU TELEMATIKA PROJEKTY (1) EudraNet EudraVigilance EudraPharm EudraGDP EudraGMP EudraCT 3

4 EU TELEMATIKA PROJEKTY (2) EudraCT EudraGMP EudraNet EudraPharm databáze všech KH na území EU (EudraCT Number) databáze povolení výroby a certifikátu GMP komunikační síť ( Intranet pro DRAs a EMEA) databáze všech LP registrovaných na území EU EudraVigilance systém farmakovigilance na území EEA, spuštěn v prosinci 2001 (Directive 2001/20/EC, Regulation 726/2004) databáze hlášených NÚL na území EEA jednotná struktura informací - ICH specifikace automatizované zpracování informací XML formát rozšíření o hlášení NÚ během klinických hodnocení (SUSARs) 4

5 EU TELEMATIKA PROJEKTY (3) The following systems make up the EU Telematics programme: EudraCT: a database containing registrations of clinical trials; EudraGMDP: support for regulatory activities in the areas of manufacturing and distribution; EudraLink: the European medicines regulatory network s secure file-transfer system used for exchanging information for regulatory purposes; EudraNet: a private electronic network linking the members of the European medicines regulatory network and the Agency; EudraPharm: a database of authorised medicinal products; EU Veterinary Medicinal Product Database: a database of authorised veterinary medicinal products; EudraVigilance: a system monitoring the post-authorisation safety of medicines through safety reports; EudraVigilance Veterinary: a network and database management system for the exchange, processing, and evaluation of suspected adverse events related to veterinary medicines; European Review System (EURS): a system that enables regulatory authorities in Member States and the Agency to receive, validate and store marketing-authorisation applications and to make them available for review; EU Telematics Controlled Terms (EUTCT): a central repository and publication system for controlled term lists used in the European medicines regulatory network; Standards for Electronic Submission (esubmission): electronic marketing-authorisation applications. 5

6 EUDRACT Legal basis: Article 11 of Directive 2001/21/EC and articles 41 and 53 of Regulation (EC) No. 1901/2006 EudraCT is the EU system for the registration of clinical trials. The current project extends the functionality in line with the requirements of the Paediatric Regulation and enhancement requests from the HMA's Clinical Trials Facilitation Group (CTFG). Key amongst the changes is the publication of results and the identification and publication of certain items relating to paediatric indications within the database. Some data on the results of clinical trials will be made available to the general public. The system is used by National Competent Authorities to monitor aspects of clinical trials being undertaken in Europe. The system entered into production in May

7 EUDRACT 7

8 EUDRACT 8

9 EUDRAGMDP Legal basis: Article 40(4) of Directive 2004/27/EC and article 44(4) of Directive 2004/28/EC EudraGMP facilitates the exchange of information on compliance with good manufacturing practice (GMP) among the competent regulatory authorities within the European medicines network. The system allows the submission of GMP certificates and manufacturing and importation authorisations by national competent authorities on-line and via an XML-based interface using the gateway; enables the submission of non-compliance with GMP information that results from inspection activity; allows the sharing of information on planned inspection activity on manufacturing sites in third countries; permits the consultation of the GMP, authorisation, non-compliance and inspection coordination information that results from the above submissions; and supports the exchange of information constituting 'rapid alerts' arising out of faulty manufacture. The database provides public access to information about manufacturing authorisations and GMP compliance certificates. Extension of EudraGMP to accommodate the requirements of good distribution practice as an anti-counterfeit measure. The system has been in production since

10 EUDRAGMDP 10

11 EUDRANET Legal basis: Articles 26 and 51 of Regulation (EC) 726/2004 EudraNet is a secure network and the backbone of the European Medicines Regulatory System. It facilitates secure communication, and also enables secure access to applications hosted at the European Medicines Agency, for example, EudraGMP. All Member State competent authorities and the European Commission have access to this system and the system has been in full operation since Industry or nonregulatory organisations do not have access to EudraNet. There is a Technical Implementation Group (TIG) in place to reflect user requirements and provide feedback on performance together with ongoing issues. The same TIG also oversees the EudraLink system for secure exchange of information. 11

12 EUDRANET 12

13 EUDRAVIGILANCE Legal basis: Article 6 of Directive 2001/83/EC as amended by Directive 2004/27/EC, Directive 2001/82/EC as amended by Directive 2004/24/EC, and Regulation (EC) No. 726/2004). EudraVigilance is the EU database on adverse drug reactions that receives, processes and stores individual case safety reports for all medicines authorised in the European Union, wherever in the world the adverse reaction reported occurred. The EudraVigilance Data Analysis System (EVDAS) provides the capability to analyse the data for signals. The system also receives, processes, and makes available for analysis in the same way reported suspected unexpected serious adverse reactions that occur during clinical trials. In production for use across the European medicines regulatory network since

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15 EUDRAVIGILANCE 15

16 EUDRAPHARM Legal basis: Articles 57 (1) and 57 (2) of Regulation (EC) 726/2004 EudraPharm is a database designed to hold information on each medicinal product (Human and Veterinary use) authorised in the European Union, and the European Economic Area. The system is required to hold the information contained in the Summary of Product Characteristics, the Package Leaflet and the labelling. Its purpose is to provide authoritative information to all stakeholders, including in particular the general public. In production for core information and linked product information documents for medicinal products for human and veterinary use authorised via the centralised procedure since December First set of information relating to products authorised by Member State competent authorities published in January

17 EUDRAPHARM 17

18 AISLP AUTOMATIZOVANÝ INFORMAČNÍ SYSTÉM LÉČIVÝCH PŘÍPRAVKŮ AISLP je informační systém (databáze) LP registrovaných v ČR, schvalovaných SÚKL i centralizovanou procedurou (EMA), parafarmaceutik a zdravotnických prostředků. Vznik: SÚKL, 80. léta, původně jako db pro evidenci NÚL Nyní: SÚKL nová on-line db DLP Komerčně využívaná db - AISLP (placené informace) Internetová-verze (od roku 2000) Aktualizace čtvrtletně 18

19 AISLP HOME PAGE 19

20 ZDROJE DAT PRO AISLP 20

21 VYHLEDÁVÁNÍ V AISLP Podle: názvu přípravku kódu SÚKL názvu léčivé látky ATC klasifikace i textové vyhledávání 21

22 INFORMACE V AISLP SmPC příbalová informace kompendiální článek stručná anglická informace informace o složení informace o způsobu výdeje informace o cenách a úhradách preskripční a indikační omezení 22

23 CESP COMMON EUROPEAN SUBMISSION PORTAL jednoduchý a bezpečný mechanismus pro výměnu informací mezi žadatelem o registraci a regulatorní autoritou při registraci účtu možnost školení formou webinaru 23

24 CESP 24

25 ESUBMISSION GATEWAY Pro centralizovanou proceduru (eaf) 25

26 ESUBMISSION ROADMAP ( R E F L E C T IN G F I N A L A D O P T E D V E R S I O N 1. 0 D A T E D ) draft esub Roadmap NCA & industry survey esub Roadmap Adoption Ongoing/optional Mandatory Use of ectd v.4 All submissions in CP (human) in ectd New MAA in DCP (human) in ectd Use of NeeS and ectd in DCP and MRP (human) All submissions in MRP (human) New MAA in DCP and MRP (human) in ectd All other MRP submissions (human) All submissions in CP, DCP and MRP (human) in ectd Use of VNeeS in CP, DCP and MRP (vet) New MAA in CP and DCP (vet) in VNeeS All other in CP and all MRP submissions (vet) All submissions in CP, DCP and MRP (vet) in VNeeS egateway (CP) (human and vet) CESP (human and vet) egateway (CP, human) Use of eaf in all procedures (human and vet) in CP in all other procedures Single submission portal - combined CESP/Gateway in CP (human) Single submission portal - combined CESP/Gateway in all other procedures (human and vet) eaf in all procedures (human and vet) Single Submission Portal with integration of eaf for all submissions (human and vet) NCA use of Common Repository for CP submissions (human) NCA use of Common Repository for all CP submissions (human) Use of PSUR Repository for CAPs and NAPs (human) Use of PSUR Repository for all CAPs and NAPs (human) ESUBMISSION ROADMAP TIMELINES