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.
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
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
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.
ON THE OTHER HAND … COMPLAINT PRESENTED TO THE PERMANENT PEOPLE’S TRIBUNAL