I worked with INVIMA, the medicine regulatory authority from Colombia since 2006 to 2007, and as a consultant to IFARMA, PAHO and to the National University of Colombia, I have delvolped different projects in pharmacuetical policy and regulation. The purpose of this presentation is to share with you different strategies that INVIMA have been implemented to guarantee quality of medicines in local level, and some important outcomes, and also to give some approaches from my experience in regional level that perhaps will help as inputs to the discussion of this round table.
From sanitary and epidemiology surveillance, quality of medicines has to ensure the maximum benefit to the last consumer (patients) with minimum risk, which is the main interest of the DRAs, that’s the reason why to preserve quality throughout all the medicines chain involves all steps like: research, registration (including medicines promotion and labelling), manufacturing, and use.
Promotion information of labs The solution can’t be generic, the solution must be original… News about Doubts about the quality of some generic medicines in Argentina
In 1995 there were in Colombia 32 international labs and 100 national ones, in 2004 only 11 international labs remained and national ones increases to 126. From the NRAs interest, I think that one of the most important steps that have a positive impact on quality of medicines is the guarantee of GMP. Therefore, NRAs have to make important efforts to maintain a good GMP standard requirement, and to preserve it, this is one of the big efforts of INVIMA in Colombia from middle 90s and still now, and it have important outcomes that support manufacturing capacities in the local pharmaceutical industry, and brings an important standard for quality of medicines.
-Post market surveillance, most of the NRAs from LA lack enough budget for performance focus programs on this issue. In Colombia there is a quality special post market program calls PROVE QUALITY , it is leading by INVIMA and collects year-by-year pharmaceutical samples in different steps of supply and dispenses chain, as a main outcome, INVIMA knows that quality compliance is between 92 and 96%, and identify the main quality problems in market chain in which the NRA has to focus its efforts. Even though, these programmes bring many advantages to the NRAs, they demand many resources. For example, the average budget of PROVE QUALITY in 2009 was US$139.500.
From my experience in Ivnima and as consultant to IFARMA, I know other Medicine Regulatory Authorities experiences and inciatives that perhaps could bring inputs to this meeting. WHO prequalification program aims to meet global standards of quality, but perhaps some issues like BE that is not a decisive quality requirement, have to be carefully reviewed, there are some countries with regulations that follows PANDRH final recomendations, and still now they are working on regulation.
Look at what are doing other agents from Civil society
Enforce weak issues
And with the river of the 5 colors from Colombia I end my intervention, thank you for your attention.
1. 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
2. Agenda <ul><li>The situation </li></ul><ul><li>INVIMA’s experience </li></ul><ul><li>Regional experience from LA </li></ul><ul><li>Recommended strategies </li></ul>
3. THE SITUATION… MEANING OF MEDICINES QUALITY, OUTLOOK FROM DRA ✔ ✔ ✔ ✔
4. THE SITUATION
5. ON THE OTHER HAND… Tomado de: Lopez Roberto ¨ Barreras a la competencia: calidad percibida... entre otras. Presentación realizada en el E ncuentro internacional sobre los avances cientificos y regulatorios en materia de bioequivalencia, calidad y politicas de competencia en el mercado de medicamentos. Colombia. 2005
6. ON THE OTHER HAND… Reggi Valerio. La OMS contra la Falsificación de Productos para la Salud. Grupo IMPACT. V Conferencia Panamericana de la REDPARF, 2008.
7. ON THE OTHER HAND … COMPLAINT PRESENTED TO THE PERMANENT PEOPLE’S TRIBUNAL
8. ON THE OTHER HAND…
9. THE SITUATION
10. INVIMA’S EXPERIENCE GMP <ul><li>GMP CAPACITIES </li></ul><ul><li>There are 174 pharmaceutical plants in Colombia, all of them have GPM certification from INVIMA* </li></ul><ul><li>*Sort: Technical Data from the Biologic and Medicines Area from INVIMA </li></ul>
11. INVIMA’S EXPERIENCE POST MARKET SURVEILLANCE PROGRAM <ul><li>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%. </li></ul><ul><li>Three decades ago the % of compliance was between 30 and 35% in Colombia. </li></ul><ul><li>Most of the findings are related with storage and transportation conditions. </li></ul><ul><li>Consolidation of national web of reference laboratories, alliance with Public Pharmacy Faculties </li></ul><ul><li>*Sort: Technical Data from the Biologic and Medicines Area from INVIMA </li></ul>
12. INVIMA’S EXPERIENCE POST MARKET SURVEILLANCE PROGRAM
13. INVIMA’S EXPERIENCE EPIDEMIOLOGY SURVEILLANCE <ul><li>PHARMACOVIGILANCE </li></ul><ul><ul><li>Voluntary report </li></ul></ul><ul><ul><li>National network of pharmacovigilance </li></ul></ul><ul><ul><li>Periodic bulletins </li></ul></ul><ul><ul><li>Multicentric study </li></ul></ul><ul><ul><li>Information Center of Medicines (Universidad Nacional de Colombia) </li></ul></ul><ul><ul><li>Risk manage </li></ul></ul><ul><ul><li>Alliance with PAHO and Universidad Nacional </li></ul></ul>
14. REGIONAL EXPERIENCE FROM LA <ul><li>Subregional Integration Forums: </li></ul><ul><ul><li>CA-SICA: IDB regional project “Centroamerican Protocol of Quality Control”, improve technical capacities and laboratories local and regional framework. </li></ul></ul><ul><li>PAHO </li></ul><ul><ul><li>Priorities from PAHO: WHO Prequalification Program, biological and biotechnological medicines. </li></ul></ul><ul><ul><li>REDPARF, PAHO harmonization network in issues like GMP, BE, pharmacovigilance </li></ul></ul><ul><ul><li>Five countries are part of WHO Prequalification Program </li></ul></ul><ul><li>OAXACA Meeting of DRA </li></ul><ul><ul><li>GPM joint visits </li></ul></ul>
15. RECOMMENDED STRATEGIES OTHER AGENTS…
16. RECOMMENDED STRATEGIES OTHER AGENTS…
17. RECOMMENDED STRATEGIES OTHER AGENTS…
18. RECOMENDED STRATEGIES OTHER AGENTS…
19. RECOMMENDED STRATEGY NUMBER 1
20. RECOMMENDED STRATEGY NUMBER 2 <ul><li>Post market surveilliance </li></ul><ul><li>Research and development </li></ul><ul><li>Promotion </li></ul><ul><li>Use </li></ul>