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HowcanwetouchKoreaPharmaceuticalMarket2007

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HowcanwetouchKoreaPharmaceuticalMarket2007 Powered By Docstoc
					     How can we touch
Korean Pharmaceutical Market
                May 30th - June 1st , 2007
                                                             Korea
                                                             &
                                                             Asia




   We are dedicated to professional, individualized and market-specific
                                 solutions
  to make our clients expansion into Korea and global markets successful
Contents


 I. Overview of Korea Market

 II. Health Authorities

 III. Registration of Pharmaceutical Products in Korea

 IV. Health Insurance System (Reimbursement)

 V. Hot Issues in 2007
I.       Overview of Korea Market
     1. Pharmaceutical biz vs GNI
     2. Pharma Manufacturing Biz Vs Total Korea Manufacturing Biz
     3. Overview by Manufacturing Volume.
     4. Local Leading Pharmaceutical Companies
     5. Overview of Manufacturing Vs Imported products

II. Health Authorities
III. Registration of Pharmaceutical Products in Korea
IV. Health Insurance System (Reimbursement)
V. Hot Issues in 2007
I. Overview of Korea Market
     - Pharmaceutical biz vs GNI
                                                                             (Unit: Billion USD/%)




 Data Source: www.bok.or.kr Korea Pharmaceutical Manufacturers Association
  I. Overview of Korea Market
       - Pharma Manufacturing biz Vs Total Korea Manufacturing Biz          (Unit: Billion UDS/%)




Data Source: www.bok.or.kr Korea Pharmaceutical Manufacturers Association
I. Overview of Korea Market
     - Overview by Manufacturing Volume.   (Unit: Million UDS)
I. Overview of Korea Market
     - Local Leading Pharmaceutical companies
                                                (Unit: USD)
I. Overview of Korea Market
     - Production (2001-2005)
                                (Unit: USD)
I. Overview of Korea Market
     - Importing (2001-2005)
                                                        (Unit: USD)




Data Source: Korea Pharmaceutical Traders Association
I. Overview of Korea Market
     - Imported products (country of origin) -2005-
                                                        (Unit: USD)




Data Source: Korea Pharmaceutical Traders Association
I.    Overview of Korea Market
II. Health Authorities
 1. Role of MOHW and Korea FDA
 2. KFDA Organization
III. Registration of Pharmaceutical products in Korea
IV. Health insurance system (Reimbursement)
V. Hot Issues in 2007
II. Health Authorities/
The Role of MOHW (Ministry of Health&Welfare) and KFDA(Korea FDA)


        MOHW
                                 KFDA Headquarter              6 Regional KFDA
•Health Insurance
               Policy
•Health & Medical         •Product Registration          •Product Notification
                          - Drug                         - Drug
               Policy                                    - Quasi Drug
                          - Quasi Drug
                          - Medical Device               - Medical Device
                          - Functional Food              - Functional Food
                          - Cosmetic
                                                         •Business Authorization
          HIRA
                          •Business Authorization        -Drug Importer
                                                         - Functional Food Importer
•Health Insurance         - Manufacturer license
                          - KGMP Inspection (Drug, MD)
• Evaluation of           - GLP & GCP Inspection         •Quality Management
Pharmacoeconomic                                          System Audit
•Evaluation of Price      •Post Market Surveillance
II. Health Authorities/
KFDA(Korea FDA) Organization

Headquarter : 6 Bureaus
  - Pharmaceutical Bureau
  - Biological Bureau
  - Medical Device Bureau
  - Functional Food Bureau
  - Food Bureau
  - Policy & publicity Bureau
6 Regional KFDA
CPAC ( Central Pharmaceuticals Affairs Council)
NITR( National Institute of Toxicology Research)
II. Health Authorities/
KFDA(Korea FDA) Organization/Pharmaceutical Bureau


•   Pharmaceutical Safety Policy Team
•   Pharmaceutical Management Team
•   Narcotic Control Team
•   Drug Evaluation Department (6 teams)
•   Herbal Medicines Evaluation Department (2 teams)

cf) Biologics Bureau(8 teams) is separated from the Pharmaceuticals
    Bureau
II. Health Authorities
KFDA(Korea FDA) Organization/ Diagram
                                      청       장
                                                             감 사 관
                                      차       장
                                                           혁신기획관



      정책홍보관리      식   품   본   부   영양기능식품              의 약 품 본 부      생물의약품본부             의료기기본부
 운    본    부                      본    부
 영
 지
 원
 팀    재 정 기 획 팀   식품안전정책팀         건강기능식품팀             의약품안전정책팀       생 물 의 약 품 팀         의료기기안전팀
      행 정 법 무 팀   식 품 관 리 팀       건강기능식품규격팀           의 약 품 관 리 팀    세   균   백   신   팀   의료기기관리팀
      통 상 협 력 팀   수 입 식 품 팀       영   양   평   가   팀   마 약 관 리 팀      바 이러 스백신팀
      정 책 홍 보 팀   식품안전기준팀         식 품 첨 가 물 팀                        혈   액   제   제   팀
      고 객 지 원 팀   위해정보관리팀                                            재 조합 의약품팀
      연구기획조정팀                                                        유 전자 치료제팀
                                                                     세포조직공학제제팀
                                                                     생 물진 단제제팀
  국립독성연구원

                  식 품 평 가 부                           의 약 품 평 가 부    생 약 평 가 부           의료기기평가부
     지방청(6)
                  식 품 규 격 팀                           의 약 품 규 격 팀    생 약 규 격 팀           의료기기규격팀
                  식 품 미 생 물 팀                         항생항암의약품팀       생 약 제 제 팀           전자의료기기팀
                  잔류화학물질팀                             기관게용의약품팀                           방 사 선 표 준 팀
                  식품오염물질팀                             마약신경계의약품팀                          방 사 선 방 어 팀
                  용 기 포 장 팀                           의약품동등성팀
                                                      화장품의약외품팀
I.         Overview of Korea Market
II. Health Authorities
III. Registration of Pharmaceutical Products in Korea
     1. Biz License
     2. Product registration
     3. KGMP, KGSP, KGCP,PMS

III. Health Insurance System (Reimbursement)
IV. Hot Issues in 2007
III. Registration/ Biz Licenses


 Product registration can be applied by Local manufacturer and importer only
 Manufacturer license :
    - Issued by central KFDA
    - Korea GMP (each dosage forms each products)
 Importer license :
    - Issued by Regional KFDA
    - Importing quality management system
 Distributor license :
    - Issued by Central KFDA
    - KGSP and 500 Mil. Won (Min. initial fund)
III. Registration/ Classification




  New Drugs
  Non-new drugs, but requiring S&E data submission
  Non-new drugs, but requiring only S&TM data submission
  Notified Drugs
  Active Pharmaceutical Ingredients
III. Registration/ Classification/New Drug


 Definition : A drug preparation containing New Medicinal Substance(s)* as
              APIs(Active Pharmaceutical Ingredients) .

  * New Medicinal Substance : substances with entirely different chemical structure
    or material composition from those of drugs which have been approved in Korea.

  * Exception : A drug listed in the KP(Korea Pharmacopoeia) or foreign
    official pharmacopoeia/compendium of drugs(USP, JP etc.) or KPC(KFDA
    Notification of S&TM)

 Process : S&TM Evaluation (Specification and Test Method)
            S&E Evaluation (Safety and Efficacy)
            DMF(Drug Master File) for APIs
            IND(Investigational New Drug) etc.
III. Registration/ Classification/Non-new Drugs, but Requiring S&E Data
Submission

 Definition : A drug that is not a “New Drug” but is subject to S&E data submission

* The subject drugs of S&E Evaluation;
        a) drug with a New API (isomer etc.) : almost New drug
        b) drug with a New Composition of API (combined) : subject to New drug
        c) drug with Increased / Decreased Contents of API
        d) drug with a New Administration route
        e) drug with a New Dosage form
        f) and when KFDA considers the drug needs S&E Evaluation.


 Process : S&TM Evaluation (Specification and Test Method)
            S&E Evaluation (Safety and Efficacy)
            DMF(Drug Master File) for APIs in some cases
III. Registration/ Classification/Non-new drugs, but only requiring S&TM
data submission- normal Generic drug

  Definition : A drug that is not a “New Drug” and not is subject to S&E data
                submission, but requiring S&TM data

 * The subject drugs of S&TM Evaluation only ;
         a) drug is identical with a drug already approved in Korea in terms of
            API, its specification & composition and dosage form.
         b) drug is listed in the KP or foreign official pharmacopoeia/
            compendia of drugs or KPC S&E Evaluation.

  * Foreign official pharmacopoeia/ compendia of drugs
   : USP, JP, EP,BP / PDR, Japan compendia of drugs, ABPI data sheet compendium,
     RoteListe, Vidal, L’ininformatore Farmaceutico, Arzneimittel Kompendium der
     Schweiz, Compendium of Pharmaceuticals and Specialties(Canada)
 III. Registration/ Classification/Notified Drugs


 Definition : A drug that is not a “New Drug” and not is subject to S&E data
              submission and not requiring S&TM data

* The subject drugs of Notification ;
         a) drug is listed in the KP
         b) drug is identical with a drug already approved in Korea and listed in
            foreign official pharmacopoeia/compendia of drugs.
          c) Subjects notified by KFDA
III. Registration/ Classification/API

 Definition : A medicinal substance that actually gives efficacy to the preparation.

 Essential requirements (DMF):
   1) BGMP(Bulk GMP),
   2) Physicochemical properties and stability data
   3) Manufacturing process, packing and IFU
   4) Certificate of analysis, S&TM and Solvent information
   5) Samples to Quality test


 DMF : It should be submitted to KFDA in the following cases;
     a) APIs for “New Drug” of which license application was
        submitted to the KFDA on or after July 1st, 2002.
    b) APIs listed in the “77 drug substances” designated by KFDA.
III. Registration / Process
                      No                         No                                   No
                            S&E Evaluation                 S&TM Evaluation                   Notified Drug ?
   New Drug ?
                              Required ?                     Required ?
            Yes                       Yes                            Yes                               Yes

 S&TM Evaluation           S&TM Evaluation               Conform to Standard               Product Notification
 ( 90 working days)          Required ?                Manufacturing Monograph ?            ( 10 working days)
                                      Yes        No
                                                         No                 Yes
       IND                  S&TM Evaluation
   Clinical Trial,                                       S&TM            S&TM
                            ( 55 working days)        ( 55 working    ( 45 working
  Bridging Study
                                                          days)           days)

  S&E Evaluation             S&E Evaluation
                            ( 45 working days)           Product         Product
 ( 60 working days)
                                                        Approval       Notification
                                                      ( 25 working    ( 10 working
                                                          days)           days)
       DMF                   Product Approval
    ( 120 days)             ( 25 working days)


                           * S&TM Review & S&E Review : KFDA HQ ‘Drug Evaluation Department’
  Product Approval         * Product Approval : KFDA/ HQ
 ( 25 working days)        * Product Notification : KFDA/ Regional Office
                           * Working days : KFDA Review time
III. Registration / S&E Evaluation


   1   Data related to origin or discovery, and development background

       Data on determination of structure, physicochemical and biological properties, including
   2   specification and test methods

   3   Stability Data           Long-term or accelerated stability data, Stress test

                                Single dose / Repeated dose toxicity, Reproductive toxicity,
   4   Toxicology Data          Genotoxicity, Immunotoxicity, Carcinogenicity, Dependency, Local
                                toxicity

   5   Pharmacology Data        Efficacy, General pharmacology, ADME


   6   Clinical Data            New Drug: Phase I, II, III, Bridging data

   7   Registration status in foreign countries

   8   Data related to similar products currently available in Korea
III. Registration / S&TM Evaluation


   1   Data related to origin or discovery, and development background

   2   Data related to registration status in foreign countries

                          Specification and test method / Certificate of Analysis
       Data on            Sample and Data on standard material and reagent
   3   preparation
                          Data on inactive ingredients
                          Data on Specific formulation, if necessary


                          Data on structural elucidation
                          Physical, Chemical and Biological Properties
       Data on each
   4                      Synthesizing Process
       API
                          Specification & Test Method / Certificate of Analysis
                          Sample and Data on standard material and reagent
III. Registration / KGMP, KGSP, PMS




                     KGMP              KGSP         PMS




   Product         Manufacturing
                    /Importing
                                      Supplying   Marketing
  Registration




                  Importer QMS
III. Registration / Korea GMP


   Preparations
      KGMP Certification per each dosage form now:
       will be changed to each product
      (Tablets/Capsules for internal use, Injection, Eye drop,
       Solution for internal / external use, Ointment, etc.)

   Active Pharmaceutical Ingredients :
     BGMP (Bulk GMP) per each manufacturing process
      (Synthesis, Fermentation, Extraction, etc.)

   Inspection
    - Periodic inspection by KFDA
    - Graded KGMP Management system
III. Registration / PMS


 Comprehensive set of measures to collect & study Safety and Efficacy data and
 necessary information for proper use of registered drugs.

 1. Drugs requiring PMS for 6 years
    a) New Drug
    b) Ethical Drug with different APIs or different administration route,
       when comparing them to approved drugs.

 2. Drugs requiring PMS for 4 years
    a) Ethical Drug with same API & administration route, but a New
       Indication.
    b) And when KFDA considers the drug needs PMS
I. Overview of Korea Market
II. Health Authorities
III. Registration of Pharmaceutical Products in Korea
IV. Health Insurance System (Reimbursement)
V. Hot Issues in 2007
  - Enforcement of Bioequivalence Test
  - Distribution with Small Package
  - Extending and Enforcing BE Test Subjects
 V. Hot Issues/cGMP and Product GMP

 Main contents in New cGMP system
  It requires Certificate of GMP for every single product instead of general
  formulation GMP certificate.

 Road map to enforcement of certification
    - New drug and ETC : 2008.7
    - OTC : 2009.7
    - API and Quasi-drug : 2010. 7
    - BE product had been enforced sine July 1st, 2006

 Enforcing Validation :
   1) Process validation
   2) Test method validation
   3) Washing validation
   4) Manufacturing support validation
   5) Computer system validation
V. Hot Issues/Compulsory Distribution with Small Package


 Execution : Effective on October 7th, 2006

 Subject: Tablets and Capsules

 Main Content :
  Manufacturer and Importer should supply at least 10% small package
  of total sale’s quantity

 Identification of small package:
  Equivalent quantity for use of 1 month and less than 100 tabs and caps
V. Hot Issues/ Extending and Enforcing BE Test Subjects


 New Designated subjects
 - Single API and Top 30% sale ETC products by HIRA checking system.
 - Single API and Expensive ETC products by HIRA check system.
 - Other : Products asked by KFDA

* Current designated subjects : No matter sale’s volume and price, ETC Products
  approved since Jan 1st, 1989 and Tablets, Capsules and Suppositories

				
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