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Avenida de Mayo 869 (C1084AAD) - Ciudad Autónoma de Buenos Aires - Argentina - Tel: 54-11-4340-0800 / 54-11-5252-8200 Experiences on harmonization and.

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Presentación del tema: "Avenida de Mayo 869 (C1084AAD) - Ciudad Autónoma de Buenos Aires - Argentina - Tel: 54-11-4340-0800 / 54-11-5252-8200 Experiences on harmonization and."— Transcripción de la presentación:

1 Avenida de Mayo 869 (C1084AAD) - Ciudad Autónoma de Buenos Aires - Argentina - Tel: 54-11-4340-0800 / 54-11-5252-8200 Experiences on harmonization and mechanisms of sub-regional integration Argentinean Experience II Workshop on Medicines Regulation in the Caribbean Strengthening of National Medicines Regulation Authorities

2 Avenida de Mayo 869 (C1084AAD) - Ciudad Autónoma de Buenos Aires - Argentina - Tel: 54-11-4340-0800 / 54-11-5252-8200 Administración Nacional de Medicamentos Alimentos y Tecnología Médica

3 Avenida de Mayo 869 (C1084AAD) - Ciudad Autónoma de Buenos Aires - Argentina - Tel: 54-11-4340-0800 / 54-11-5252-8200 National Administration of Medicines, Food and medical Technologies (devices)

4 Avenida de Mayo 869 (C1084AAD) - Ciudad Autónoma de Buenos Aires - Argentina - Tel: 54-11-4340-0800 / 54-11-5252-8200 DEPENDENT THE MINISTRY OF HEALTH OF THE NATION MISSION: TO SUPERVISE AND CONTROL ALL PRODUCTS FOR USE IN HUMAN HEALTH MINISTERIO DE SALUD

5 Avenida de Mayo 869 (C1084AAD) - Ciudad Autónoma de Buenos Aires - Argentina - Tel: 54-11-4340-0800 / 54-11- 5252-8200 NATIONAL INSTITUTE OF MEDICINE MEDICAL TECHNOLOGY DIRECTION MEDICINE EVALUATION DIRECTION LEGAL AFFAIRS DIRECTION ADMINISTRATIVE DIRECTION PLANIFICATION AND INTERNATIONAL RELATIONS DIRECTION NATIONAL DIRECTION NATIONAL INSTITUTE OF FOOD

6 Avenida de Mayo 869 (C1084AAD) - Ciudad Autónoma de Buenos Aires - Argentina - Tel: 54-11-4340-0800 / 54-11-5252-8200 OPS MERCOSUR ICH (EWG Q10 -PQS) PIC/S INTERNATIONAL RELATIONS AND PARTICIPATIONS

7 Avenida de Mayo 869 (C1084AAD) - Ciudad Autónoma de Buenos Aires - Argentina - Tel: 54-11-4340-0800 / 54-11-5252-8200 MERCOSUR BRAZIL URUGUAY PARAGUAY ARGENTINA CHILE, VENEZUELA, COLOMBIA, BOLIVIA, ECUADOR y PERU

8 Avenida de Mayo 869 (C1084AAD) - Ciudad Autónoma de Buenos Aires - Argentina - Tel: 54-11-4340-0800 / 54-11-5252-8200 SGT 11 of HEALTH PRODUCTS SEVERAL AD HOC GROUPS Psychotropic and Narcotic Herbal Medicines Blod Derivates Counterfeit Cosmétics Vaccines Others GMP

9 Avenida de Mayo 869 (C1084AAD) - Ciudad Autónoma de Buenos Aires - Argentina - Tel: 54-11-4340-0800 / 54-11-5252-8200 GMP WG DIFFICULTIES FOR HARMONIZATION of COMMON STANDARDS Diferent national laws Differences of criteria Disparity in resources Diferent procedures and mechanisms

10 Avenida de Mayo 869 (C1084AAD) - Ciudad Autónoma de Buenos Aires - Argentina - Tel: 54-11-4340-0800 / 54-11-5252-8200 STEPS FOLLOWED Identify the needs of each country Harmonization of common standards Harmonization of procedures Joint training of inspectors Joint Inspections

11 Avenida de Mayo 869 (C1084AAD) - Ciudad Autónoma de Buenos Aires - Argentina - Tel: 54-11-4340-0800 / 54-11-5252-8200 Workshops Workshops with international experts

12 Avenida de Mayo 869 (C1084AAD) - Ciudad Autónoma de Buenos Aires - Argentina - Tel: 54-11-4340-0800 / 54-11-5252-8200 Harmonization of common standards Res. GMC ( Common Market Group) Nº 59/92 : Guide for inspections of pharmaceutical industry. Res GMC 14/96 Verification of compliance with good manufacturing practices in pharmaceutical establishments (qualification of the Inspections Guide) Res GMC 23/96 Inspection procedures Res GMC 61/00 Adoption of the WHO GMP '92 Currently in harmonization for the use of GMP 'WHO 2003

13 JOIN training of inspectors MERCOSUR phase I training Course (internal in each country) Avenida de Mayo 869 (C1084AAD) - Ciudad Autónoma de Buenos Aires - Argentina - Tel: 54-11-4340-0800 / 54-11-5252-8200 MERCOSUR phase II training Course (international) MERCOSUR phase III training Course (international)

14 Avenida de Mayo 869 (C1084AAD) - Ciudad Autónoma de Buenos Aires - Argentina - Tel: 54-11-4340-0800 / 54-11-5252-8200 Only inspectors with approved Phase II training course can perform MERCOSUR joint inspections

15 Avenida de Mayo 869 (C1084AAD) - Ciudad Autónoma de Buenos Aires - Argentina - Tel: 54-11-4340-0800 / 54-11-5252-8200 The armonization process is Continuous Continuous updating of harmonized standards

16 Avenida de Mayo 869 (C1084AAD) - Ciudad Autónoma de Buenos Aires - Argentina - Tel: 54-11-4340-0800 / 54-11-5252-8200 The GMP group is currently working on a unified report model with minimum standard content So… The armonization and the updating continues

17 Avenida de Mayo 869 (C1084AAD) - Ciudad Autónoma de Buenos Aires - Argentina - Tel: 54-11-4340-0800 / 54-11-5252-8200 NO MUTUAL RECOGNITION OF INSPECTIONS EXCHANGE OF INFORMATION WITH EXCHANGE OF INSPECTION REPORTS AND ANALYSIS OF THOSE REPORTS BY THE RECEPTOR COUNTRY, WHICH HAS THE DECISION POWER TO ACCEPT OR NOT, AND REQUEST THE JOINT INSPECTION.-

18 Avenida de Mayo 869 (C1084AAD) - Ciudad Autónoma de Buenos Aires - Argentina - Tel: 54-11-4340-0800 / 54-11-5252-8200 At that point the exchange of information with the possibility of its acceptance, it was after all we said before: years of joint inspections and joint training of inspectors

19 Avenida de Mayo 869 (C1084AAD) - Ciudad Autónoma de Buenos Aires - Argentina - Tel: 54-11-4340-0800 / 54-11-5252-8200 ASSISTED INSPECTION

20 Avenida de Mayo 869 (C1084AAD) - Ciudad Autónoma de Buenos Aires - Argentina - Tel: 54-11-4340-0800 / 54-11-5252-8200 ANMAT, through INAME, also interacts with PIC/S countries wich is full member since january 2008

21 Avenida de Mayo 869 (C1084AAD) - Ciudad Autónoma de Buenos Aires - Argentina - Tel: 54-11-4340-0800 / 54-11-5252-8200 BENEFITS Information and experiences exchange (with regulators from many countries (Europe, Asia, Africa) Join tarining for inspectors Joint inspections

22 Avenida de Mayo 869 (C1084AAD) - Ciudad Autónoma de Buenos Aires - Argentina - Tel: 54-11-4340-0800 / 54-11-5252-8200 Participation in Expert Circles (ANMAT participates in the expert circle of risk analysis) Rapid Alert Notifications System (receiving, from many countries in the world, quality defects notifications of products that may occasionally reach the Argentine market).

23 Avenida de Mayo 869 (C1084AAD) - Ciudad Autónoma de Buenos Aires - Argentina - Tel: 54-11-4340-0800 / 54-11-5252-8200 THANKS FOR YOUR ATTENTION GRACIAS POR SU ATENCIÓN Rodolfo H. Mocchetto ANMAT – República Argentina rmocchetto@anmat.gov.ar

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