1. 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

2. 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

3. 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

4. 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

5. 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

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

7. 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

8. 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

9. 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

10. 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

11. 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

12. 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:

13. 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

14. 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

15. 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

16. 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

17. 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

18. Štátny ústav pre kontrolu liečiv
Kvetná 11
Bratislava 26