msf geneve substandard medicines

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REGULATORY CAPACITIES IN QUALITY ASSURANCE OF MEDICINES An Outlook from LA and INVIMA Roundtable III: Role of medicine regulatory authorities in developing countries and how to strengthen regulatory capacity Angela Acosta

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Page 1: MSF Geneve Substandard Medicines

REGULATORY CAPACITIES IN QUALITY ASSURANCE OF

MEDICINES An Outlook from LA and

INVIMA

Roundtable III: Role of medicine regulatory authorities in developing countries and how to

strengthen regulatory capacity

Angela Acosta

Page 2: MSF Geneve Substandard Medicines

Agenda

The situation

INVIMA’s experience

Regional experience from LA

Recommended strategies

Page 3: MSF Geneve Substandard Medicines

THE SITUATION…MEANING OF MEDICINES QUALITY,

OUTLOOK FROM DRA

✔✔ ✔✔

Page 4: MSF Geneve Substandard Medicines

THE SITUATION

Page 5: MSF Geneve Substandard Medicines

ON THE OTHER HAND…

Tomado de: Lopez Roberto ¨ Barreras a la competencia: calidad percibida... entre otras. Presentación realizada en el Encuentro internacional sobre los avances cientificos y regulatorios en materia de bioequivalencia, calidad y politicas de competencia en el mercado de medicamentos. Colombia. 2005

Page 6: MSF Geneve Substandard Medicines

ON THE OTHER HAND…

Reggi Valerio. La OMS contra la Falsificación deProductos para la Salud. Grupo IMPACT. V ConferenciaPanamericana de la REDPARF, 2008.

Page 7: MSF Geneve Substandard Medicines

ON THE OTHER HAND …

COMPLAINT PRESENTED TO THE PERMANENT PEOPLE’S TRIBUNAL

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ON THE OTHER HAND…

Page 9: MSF Geneve Substandard Medicines

THE SITUATION

Page 10: MSF Geneve Substandard Medicines

INVIMA’S EXPERIENCE GMP

GMP CAPACITIES

There are 174 pharmaceutical plants in Colombia, all of them have GPM certification from INVIMA*

*Sort: Technical Data from the Biologic and Medicines Area from INVIMA

57

98

3326

40

2634

4

60

7

0

20

40

60

80

100

2003 2004 2005 2006 POA 2006

NACIONAL INTERNACIONAL

Page 11: MSF Geneve Substandard Medicines

INVIMA’S EXPERIENCEPOST MARKET SURVEILLANCE

PROGRAM

INVIMA knows that quality compliance of medicines in Colombia is between 92 and 96%., from 2005 to 2009, similar programs of FDA and ANVISA have an non compliance % among 8 an 10%.

Three decades ago the % of compliance was between 30 and 35% in Colombia.

Most of the findings are related with storage and transportation conditions.

Consolidation of national web of reference laboratories, alliance with Public Pharmacy Faculties

*Sort: Technical Data from the Biologic and Medicines Area from INVIMA

Page 12: MSF Geneve Substandard Medicines

INVIMA’S EXPERIENCEPOST MARKET SURVEILLANCE

PROGRAM

Page 13: MSF Geneve Substandard Medicines

INVIMA’S EXPERIENCEEPIDEMIOLOGY SURVEILLANCE

PHARMACOVIGILANCE Voluntary report National network of pharmacovigilance Periodic bulletins Multicentric study Information Center of Medicines (Universidad

Nacional de Colombia) Risk manage Alliance with PAHO and Universidad Nacional

Page 14: MSF Geneve Substandard Medicines

REGIONAL EXPERIENCE FROM LA

Subregional Integration Forums: CA-SICA: IDB regional project “Centroamerican Protocol of

Quality Control”, improve technical capacities and laboratories local and regional framework.

PAHO Priorities from PAHO: WHO Prequalification Program,

biological and biotechnological medicines. REDPARF, PAHO harmonization network in issues like GMP,

BE, pharmacovigilance Five countries are part of WHO Prequalification Program

OAXACA Meeting of DRA GPM joint visits

Page 15: MSF Geneve Substandard Medicines

RECOMMENDED STRATEGIES

OTHER AGENTS…

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RECOMMENDED STRATEGIES

OTHER AGENTS…

Page 17: MSF Geneve Substandard Medicines

RECOMMENDED STRATEGIES

OTHER AGENTS…

Page 18: MSF Geneve Substandard Medicines

RECOMENDED STRATEGIESOTHER AGENTS…

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RECOMMENDED STRATEGY NUMBER 1

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RECOMMENDED STRATEGY NUMBER 2

Post market surveilliance

Research and development

Promotion

Use

Page 21: MSF Geneve Substandard Medicines

Thanks…