1. The Counter Measures for Counterfeit Drugs Control in Korea Pharmaceutical Regulatory Affairs Management May 2012

2. Global Policy Trend □ (Safety Management) Development of customized pharmaceuticals ＊ R&D of customized pharmaceuticals ＊ Trade expansion of imported pharmaceutical ingredients in China, India, etc. -> Enhancing global management □ (Pharmaceutical Market) Rising emerging pharmaceutical market, Expecting reorganization of global market ＊ Global market size: $856 billion, Annual growth rate: 6.0% ＊ Surge of Chinese market, low growth rate in developed market ＊ Patent cliff of originals, fierce competition of generics ＊ Accelerated new drug development with use of cutting-edge biotech

3. Domestic Policy Trend □ (Safety Management) Access to pharmaceuticals, Increased demand for safety management according to scientific development Establishment of national response to ADR (e.g. risk management in advance) □ (Pharmaceutical Market) Restructure of pharmaceutical industry, Management paradigm shift ※ Market size: \19.1 trillion, annual growth rate: 8.9% Globalization of pharmaceutical products □ (FTA Effect) Decline in generic, threaten domestic pharmaceutical supply ※ Drop \100 billion, income decrease of \70 billion for 10 years Expand realistic and effective support (e.g. investment in R&D)

4. The year of Establishment of National Pharmacovigilance System Globalization of Drug Approval System Enhancing RiskCentered Quality Management System

5. □ Obligation management by regulating ‘drug approval’ under the condition of prohibited behaviors □ Basic points to achieve the minimum goal of pharmaceutical administration - Surveillance/inspection and disposal, etc. □ What is the goal of pharmaceutical administration ? - To find and prevent faults What is ‘Pharmacovigilance’ ?

6. □ Pharmacovigilance Tasks Regional KFDA City·Governor (City·County·Gu; borough) ○ 6 Regional KFDA (Pharmaceutical Product Safety Division) ▶ Seoul, Busan, Gyeongin, Daegu, Gwangju, Daejeon ▶ Pharmacist/inspector : 32 ○ 16 Local Governments ▶ Seoul, 6 metropolitan city, 9 provinces ▶ Pharmacist/inspector : 740 ○ Pharmaceutical manufacturer·importer ▶ Finished products and pharmaceutical ingredients ○ Pharmaceutical distributor ▶ Wholesale ▶ Pharmacist, medical center

7. Secure world-class level public health with pharmaceutical safety Establishment of post-approval management governance system for new drugs and narcotics Vision Protect and improve public health and secure pharmaceutical safety Mission Enhancing capability Strengthening preventive inspection Establishing distribution rules

8. On-site pharmacovigilance on distributors Wholesale (KGSP included), pharmacies Pharmaceutical illegal distributor (Unlicensed places e.g. imported goods selling shops, shops for adult sexual pleasure) ※ on-line illegal distribution

9. □ Enhancing preemptive and preventive inspection Change inspection style: uniform and repeated inspection to select and focus inspection (Annual on-site inspection: 1/year) Enhancing cooperative inspection between (regional) KFDA and local governments □ Autonomic inspection of local governments, enhancing cooperative system with KFDA Enhancing cooperative inspection between KFDA and local governments Risk information share between KFDA and local governments, establishment of cooperative system Objective

10. Basic direction The autonomic management by the head of each local government for pharmaceutical distiributors, Wholesale: Autonomic inspection once a year

11. Directions to promote □ Inspection KGSP satisfying wholesales Education about KGSP autonomic inspection Result of the autonomic inspection: Submit and evaluate once a year □ Use of the result Frequent inspection (‘select & choice’) on non-participating and unsatisfied wholesales Analysis of current status of autonomic inspection As for the wholesale which suggests its problem, improvements and others for itself after the autonomic inspection, paper review or instructive visit is to be conducted.

12. Base Requests from (regional) KFDA and claims & suggestions from local governments Methods □ Intermediate inspection on claims and requests Conduct inspection on raised claims and requests

13. Through inspection on fulfillment of administrative disposal Distributors not following administrative disposal: Inspection on their fulfillment of administrative disposal and internal report of the results - Thorough and strict inspection during the period of disposal fulfillment

14. Enhancing inspection on withdrawal management If sales of marketing banned pharmaceuticals are confirmed or to-be- withdrawn pharmaceuticals are not reported to the 「 Pharmaceutical withdrawal management system 」, inspect the distributor. If a pharmaceutical must be withdrawn, wholesales (KGSP) shall report the holding amount to 「 Pharmaceutical withdrawal management system 」 (KFDA).

15. Withdrawal management system Ordering institution (Competent regional KFDA) Subject (Manufacturer ㆍ importer) Distributors (Pharmacies, wholesales, medical centers/hospitals) 1) Order of withdrawal 6) Report progress 3) Release reports 4) Report holding amount (Recommended) 5) Withdrawal 8) Request for discard 10) Report result 11) Evaluation 12) Termination 2) Report withdrawal plan 7) Real-time check 9) Confirm disposal (improvements) Managing institutions (Competent local governments) Report supply list Real-time monitoring ♧ Withdrawal system and use of withdrawal management system

16. □ Q UALITY MANAGEMENT SYSTEM KFDA ○ Plan and coordinate quality management - Establish and manage basic plan for quality management - Collect and analyze risk information - Manage related statistical data Regional KFDA ○ Special/specific collect inspection - Risk suspected products - Products with social probelms - Based on information City·Province ○ Collect inspection of being distributed pharmaceuticals - Focus on incompliance- concerned pharmaceuticals I NFORMATION EXCHANGE ( DISCUSSION ) Pharmaceutical collect inspection

17. Monitoring Investigation office : 5 Regional KFDA : 6 KFDA : 1 Primary evaluation Types of violation Conduct investigation Website address Follow-ups Conduct investigation Inspection Close website ○ Inspecting illegal website and follow ups ○ Result (2006~10) ( UNIT : PCS ) Year'07'08'09'10‘11 Close website3941684498222,413 On-line illegal distribution

18. ○ Management of advertisement and labeling crack-down - KFDA cracks down pharmaceutical advertisement - Appropriate labeling of pharmaceutical approval facts (e.g. efficacy and effectiveness, directions and dose, etc.) Advertisement/Labeling crack-down

19. Within next 10 years…..? International cooperation to crack down risk substance manufacturing facilities Immediate disposal at crack-down On-site order Information share with mobile phones Tracking location with bar-code IT-based GMP inspection Inspectors network On-site quality inspection Monitoring artificial intelligence illegal advertisement Inspection with mobile phones

20. On-line Pharm-library □ S ERVICE TYPE : A PPLICATION STORE IN THE SMARTPHONE □ START : F EBRUARY, 2012~ □ C ONTENTS ○ Pharmaceutical approval facts (efficacy, directions, cautions in use) ○ Product information (e.g. leaflet, picture of imprinted tablet ○ Bar-code search ○ Safety letter and information about withdrawn ○ ADR report and poor quality food report

21. On-line Pharm Library Beecom tbl. Search

22. ADR report Illegal and low quality drug report

23. Newsletter (Real-time)

24. Withdrawal/disposal information

25. Monitoring advertisement information  Review board : Korea Pharmaceutical Manufacturers Association (Phone : 02-597-2741)  Review commission : Advertisement review institutes, consumer organizations, pharmaceutical society, the law society, etc.  Result Classification2008200920102011 Number1,0099321,1321,351 Appropriate578474715919 Review after modification 399402368402 Inappropriate32564930 □ Advertisement review system