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TRANSCRIPT
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
Agenda
The situation
INVIMA’s experience
Regional experience from LA
Recommended strategies
THE SITUATION…MEANING OF MEDICINES QUALITY,
OUTLOOK FROM DRA
✔✔ ✔✔
THE SITUATION
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
ON THE OTHER HAND…
Reggi Valerio. La OMS contra la Falsificación deProductos para la Salud. Grupo IMPACT. V ConferenciaPanamericana de la REDPARF, 2008.
ON THE OTHER HAND …
COMPLAINT PRESENTED TO THE PERMANENT PEOPLE’S TRIBUNAL
ON THE OTHER HAND…
THE SITUATION
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
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
INVIMA’S EXPERIENCEPOST MARKET SURVEILLANCE
PROGRAM
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
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
RECOMMENDED STRATEGIES
OTHER AGENTS…
RECOMMENDED STRATEGIES
OTHER AGENTS…
RECOMMENDED STRATEGIES
OTHER AGENTS…
RECOMENDED STRATEGIESOTHER AGENTS…
RECOMMENDED STRATEGY NUMBER 1
RECOMMENDED STRATEGY NUMBER 2
Post market surveilliance
Research and development
Promotion
Use
Thanks…