PharmDr. Ján Mazag, director, State Institute for Drug Control Information on SIDC activities "Strengthening the administrative capacity of the State Institute for Drug Control as regards medicinal products for human use" Twinning project, June 15, 2007, Bratislava PharmDr. Ján Mazag, director, State Institute for Drug Control

State Institute for Drug Control - SIDC SIDC ensures the state supervision over quality, safety and efficacy of medicinal products and medical devices SIDC is reporting to the Ministry of Health SR and is a budgetary organisation depending on MoH, not on fees from applications or other sources

RESPONSIBILITY OF SIDC MAIN ACTIVITIES: - Legislative initiative - Registration and certification activity Medicines and Medical devices - Pharmacopoeia and standard setting activity - Information system - Inspection activity (GMP, GLP, GCP, GPP) - Safety of Drugs - Monitoring of the adverse drug reaction - Laboratory Control - Reimbursement process participation in Ministry of Health

INTERNATIONAL: Cooperation with EMEA, EDQM, OECD, PIC/Scheme, WHO, Other Agencies (CZ, H, SLO) Not isolated agency, but member of network in EU agencies and EMEA with neccessity to share the work

STRUCTURE OF SIDC ORGANIZATION 2 Units (Personnel office and Quality Management) „Supportive“ sections a. Administrative Section (secretary, audit, lawyer, IT) b. Economy and Maintenance Section 5 Sections a. Registration Section (for Medicinal Products) 50 b. Medical Device Section 9 c. Inspection Section + Regional Control Laboratories 54 d. Drug Safety and Clinical Trials Section 8 e. Quality Assessment of Medicines Section 47 5 Advisory Bodies

Advisory Bodies Committee for Medicinal Products Assembly for the Quality of Drugs Drug Safety Committee Pharmacopoeial Committee Ethic Committee for Animal Testing

Recent changes in 2006 Section of Medical devices team built up, starting process of standardization in managing the system of work, using and publishing the database, co-operation with NB, pharmacovigilance of medical devices Section of Inspection stabilisation of existing team with new leading manager, reorganizing the structure, building up the inspection teams, training for new tasks and analysing the outcomes of inspections from past, planning the inspections in advance according legislative demads

Recent changes in 2006 Section of Registration Concentration on applications not closed in past, identification of the reasons for opened applications from past, individual tasks and responsibilities, motivation for personnel, tracking the application in process of proceding, organisational changes, using IT in daily work Transparency and information provided : new website with new possibilities, organisation of Agency, Rapid Alert System ensuring effective information flow, searching tools in databases for pharmaceuticals, medical devices, clinical trials, inspections, alert system distribution of information, blind friendly version, system of editing the information

Agenda SIDC 2006 Number of SIDC corenspondence : 17 285 Overview of the submitted applications for information (based on law ) Number of submitted applications for information 253 Number of provided information Appeal for completion of the application Issue of the decision about non-providing of information

Registration statistic of Drugs 2006 Department of national registrations Type of application Starting point Accepted 2006 Finalised 2006 Withdrawn 2006 New application 547 91 113 33 Renewal 1797 503 815 32 Transfer 166 130 156 1 Variation 3148 964 1891 Variation 1A 729 2118 1552 18 Variation 1B 484 1370 1009 11 TOTAL 6871 5176 5536 261

Registration of Drug 2006 Department of EU procedures Type of application Accepted 2006 Finalised 2006 DCP new application 301 6 MRP new application 359 430 MRP notification 2418 1863 MRP variation 708 539 MRP renewal 72 3 Transfer 25 22 Referrals 28 48 TOTAL 3911 2911 CP-QRD n   100% COMP-QRD

Inspection 2006 Inspection activity was performed: - in the facilities providing pharmacy care (public pharmacies, branches of public pharmacies, hospital pharmacies) - in the distribution organizations - inspections in manufacturers - in another facilities (poppy producers, opticians, etc.) Total number of inspections performed: 824 Total number of samples taken: 354

Clinical Trials 2006 Activity Number Application for clinical trial 151 Authorization of clinical trials of drugs 128 Rejection of application for clinical trial 2 Application on approving of amendment to protocol 242 Application/notification on changes in Investigator's Brochure Application on approving of a new study centre 19 Submission of agreement of ethical committee 135 Notice on beginning of clinical trial 38 Notice on end of clinical trial 87 Annual report on process of a clinical trial 103 Report on adverse event from Slovak trial sites 301 Notice on adverse event from abroad 5856 Own activity 69 Other 387 Application for clinical trial with medical device 3 Authorization of clinical trial with medical device Inspection of GCP 8

Medical Devices 2006 Summary of acivities of the Medical Device Section: Number of received registration forms of medical devices 1 106 Notification of adverse effects of medical devices 536 New codes assigned 3 093 Updated codes 4 922 Inspections of wholesale distributors 16 Repeated inspections of wholesale distributors 9 Suggestions for inspections of wholesale distributors 1 Assessment reports for wholesale distribution license 11 Clinical complaints Notification of clinical testing 2

Pharmaceutical system in Slovakia in 2005 (out- patient sector) 1. Registration EMEA / State Institute for Drug Control (SIDC) Quality, safety, efficacy (Directive 2006/27/EC) Act on pharmaceuticals and medical devices 2.Classification State Institute for Durg Controls (SIDC) Categories: POM, POM only prescribes by certain specialists, and OTC ↓ ↓ 3. Pricing Ministry of Health - Determination of the pharmacy retail price - Criteria:international price comparison for imported pharmaceuticals, production costs for locally produced pharmaceuticals Free pricing 4. Reimbursement ↓ Ministry of Health, advised by the Categorisation Cimmittee - Decision on reimbursement price - Criteria:therapeutic benefit, internal price comparison No reimbursement ↓ ↓ 5. Distribution Patients

Challenges and harmonised on national level by Ministry of Health Legislation approved on EU level and harmonised on national level by Ministry of Health Obligations in NCA shoulders mostly Referrals, Clinical trials, PSURs, Pharmacovigilance and RMPs, Advertising and promoting regulations, registration procedures (MRP, DCP, CP, NR), Information to patients, Herbal directive, Standardisation, Patent and data edxclusivity Paediatric regulations and Advanced therapy legislation in process Blood products and inspections in health care facilities

Challenges WORKSHARE PRINCIPLE IN NETWORK If we can not participate then other agency has to prioritize their work, Better solution is to learn to participate the work in Network Section of registration: Improving management system and training employers, possible changes in organigram, Persons responsible for dossier (PTL), identification of processes and responsibilities, Built –up assessors in house, external, training, pool of external assessors

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