1. Analysing the EU PVG regulations Manoj SHARMA,Ph.D (Clin.Pharmacology, FRANCE) Pharmacovigilance Unit Clinical Research Department Panacea Biotec.

4. Current trend in pharmacovigilance PHARMACOVIGILANCE PVG should start before initiating phase I studies and continue through the Life cycle of the product

8. EU PVG regulations Served as a model for development of ICH E2A and E2C CIOMS working group I and II CIOMS/WHO Working Group on Vaccine Pharmacovigilance Management of Safety Information from Clinical Trials. CIOMS working group VI Current challenges in Pharmacovigilance: Pragmatic approaches CIOMS working group V Benefit-Risk balance for marketed drugs. Evaluating safety signals. CIOMS working group IV Guidelines for preparing core clincial safety information (CCSI) CIOMS working group III The Rules Governing Medicinal Products in the European Union – Guidelines on Pharmacovigilance for Medicinal Products for Human Use Vol 9A Good Clinical Practices E6 Development safety update report E2F Pharmacovigilance planning for the early postmarketing period of a new drug (chemical entities, biotechnology-derived products, and vaccines) E2E Post-approval safety data managament: Definitions ans standards for Expedited reporting E2D Clinical Safety data management: Periodic Safety update report (PSUR) E2C Data elements for transmission of ICSRs E2BM Clinical safety data management: Definitions and standards for expedited reporting E2A

9. The national pharmacovigilance systems of the Member states together form the pharmacovigilance system in the EU Cooperates in a network structure under the co-ordination of the EMEA and in Liasion with the European Commission. EEA: Norway, Iceland and Liechtenstein Pharmacovigilance model

10. Member states and RA Source: European Commission ,Enterprise and Industry Directorate General,2006 Regulatory Authority Member state MHRA United Kingdom Pharmacovigilance Unit Medicinal Product Agency Sweden -Agencia Espanola de Medicamentos y Productos Sanitarios Spain INFARMED, Departmento de Farmacovigilancia Portugal -College ter Beoordeling van Geneesmiddelen/ Medicines Evaluation Board Netherlands Direction de la Santé Division de la Pharmacie at des Médicament Luxembourg Drug Safety ssociate, Pharmacovigilance Unit, Irish Medicines Board Ireland Italian Medicines Agency-AIFA Italy National Organisation for Medicines (EOF) Division of Pharmaceutical Studies and Research Greece Bundesinstitut fur Arzeneimittel und Medizinprodukte (BfArM) Germany Agence Française de Sécurité Sanitaire des Produits de Sante France Clinical Trials Enforcement & Inspection National Agency for Medicines Finland The Danish Medicines Agency Clinical Trials, Inspection and Enforcement Division Denmark Federal Public Service Health, Food Chain Safety and Enviornment Directorate-General Medicinal Products Belgium

13. Legal Basis, Principles and Organisation of EU PVG System

15. European PVG : National or Mutual recognition licensing procedures

16. European PVG for Medicinal Products : National or Mutual Recognition Licensing Procedure Title IX of Directive 2001/83/EC (PVG Obligations) Agency (EMEA) MAH EC European Comission Member States (MS ) Article 106 in relation to publication of PVG guidance Article 105 : collaboration with MS and EC, to set up a data processing network for exchange of PVG information to enable all the competent authorities to share PVG information at the same time Article 101 : reporting of ADRS by HCP to competent authorities Article 105: ensure reporting to agency, otherMS and MAH with in 15 days using agency’s data processing network Article 103: QPPV Article104: Obligations of MAH

19. Marketing Authorization Holder

22. The Agency (EMEA)

23. GUIDANCE Article 106 of Directive 2001/83/EC and Article 26 of Regulation (EC) No. 726/2004 require the Commission, in consultation with the agency, the Member States and interested parties, to produce guidance on the collection, verification and presentation of adverse reaction reports so as to facilitate the exchange of pharmacovigilance information with in the EU

28. European PVG : Centrally Authorised Medicinal Products

29. European PVG : Centrally Authorised Medicinal Products Title II (Chapter 3) of Regulation (EC) No.726/2004 Agency (EMEA) MAH EC European Comission Member States (MS ) Article 26 in relation to publication of PVG guidance Article 22: Obligations of MAH Article23: QPPV Article 24: reporting requirements and PSUR PVG (Human Use) Article 22 : Cooperation with national pharmacovigilance systems. Article 27: Collaboration with WHO Article 57 (1) (d) : Dissemination of information on adverse reactions. Use of database (Eudravigilance) Article 22 : competent authorities of member states to ensure that all relevant information about suspected adverse reactions to centrally authorised products Article 25: member states to record and report them to agency and MAH with in 15 days of reciept of information/

31. The Agency (EMEA): Centrally Authorised Product

33. Marketing Authorization Holder : Centrally Authorised Product QPPV Role MAH MAH

34. Clinical Trial Directive

35. Clinical Trials Directive

37. European Pharmacovigilance-Member State Implementation

38. United Kingdom: Post licensing division and Comission on Human Medicines (CHM) Suspected ADR reporting Yellow Card ADROIT Database For urgent medicinal product hazard warning Dear Health Care Professional Letters Evaluation of reports to identify possible risk factors contributing to the occurrence of the reactions Source:http://www.opsi.gov.uk

41. France Agence française de sécurité sanitaire des produits de sainté Source:http://www.afssaps.fr/

45. Thank You! from