Presenter to insert their organization’s logo and information here BIOEQUIVALENCE AND GOOD MANUFACTURING PRACTICES (GMP) IN CHILE

2 Based on American normatives (FDA), European regulations, WHO recommendations and type IV Agencies: Establish the requirements for: Submissions of study protocols or designs before performing bioequivalence studies Submissions of BE study results performed under the jurisdictions of regulatory agencies accepted by the Agencia Nacional de Medicamentos (ANAMED) or Submissions of prequalified drug products as bioequivalent under the WHO prequalification program (HIV, Tuberculosis) BIOEQUIVALENCE STUDIES

3 The requirement is a stepwise process Pharmaceutical labs programming 12 drugs December 2013 December Registered products 732 Registered products 930 Registered products 21 drugs October Registered products Decree drugs 49 drugs Decree 981 Group A +++ Decree 500 December drugs 309 Registered products Decree 981 Group B Decree 981 Group C Chronogram of requirements to demonstrate BE acording to the decrees

4 ISP Oversees a 100% of manufacturing pharmaceutical companies and follows up to verify compliance with good manufacturing practices OVERSIGHT OVERSIGHT AND DRUG CONTROLS number June

5 OVERSIGHT GMP COMPLIANCE THROUGH JUNE 2013 It is important to point out that GMP are tools of the quality system and as such they contain elements for the continuous improvement and therefore, there will always be parameters to get better All pharmaceutical companies comply at certain levels with the requirements established under the inspection guideline based on the recommendation of the WHO Number of pharmaceutical companies according to their type Years number

6 NATIONAL BE CENTERS AUTHORIZED BY ISP Bioequivalence National centersnumber% IN VITRO/BIOWAIVER1263% IN VIVO737% Total19 BIOWAIVER CENTERS 1 LABORATORIO BAGÓ DE CHILE S.A. 2LABORATORIOS ANDRÓMACO S.A. 3LABORATORIO CHILE S.A. 4LABORATORIOS RECALCINE S.A. 5LABORATORIOS SAVAL S.A. 6LABORATORIO DAVIS S.A. 7INSTITUTO SANITAS S.A. 8 LABORATORIO MINTLAB Co. S.A. 9LABORATORIOS GARDEN HOUSE FARMACÉUTICA LTDA. 10LABORATORIOS BIOEQ 11LABORATORIOS MEDIPHARM 12LABORATORIOS EUROMED CHILE S.A. IN VIVO CENTERS 1LABORATORIO DE INVESTIGACIONES FARMACOLÓGICAS Y TOXICOLÓGICAS (IFT) UNIVERSIDAD DE CHILE 2UNIDAD DE BIOEQUIVALENCIA CENTRO DE INVESTIGACIÓN CLÍNICA UNIVERSIDAD CATÓLICA DE CHILE 3CENTRO DE ESTUDIOS DE BIOEQUIVALENCIA DE LA SOCIEDAD DE LABORATORIOS DEL DESARROLLO S.A. (CEBE) 4LABORATORIO DE ANÁLISIS DE MEDICAMENTOS EN FLUIDOS BIOLÓGICOS DE AGRIQUEM AMÉRICA S.A. 5CENTRO DE DESARROLLO EN TECNOLOGÍA FARMACÉUTICA (CEDETEF) DE LA FACULTAD DE CIENCIAS QUÍMICAS Y FARMACÉUTICAS DE LA UNIVERSIDAD DE CHILE 6CENTRO DE INVESTIGACIONES AVANZADAS EN BIOMEDICINA DE LA UNIVERSIDAD DE CONCEPCIÓN (CIAB-UdeC) 7SERVICIOS Y ASESORIAS INNOLAB LIMITADA

7 Bioequivalence Foreign centers authorized by ISP Foreign centernumber% IN VITRO/BIOWAIVER431% IN VIVO969% Total13 IN VITRO CENTERS / BIOWAIVER 1 BIOSERVICIOS S.R.L. (Argentina) 2DOMÍNGUEZ LABORATORIO (Argentina) 3ICF SOLUCÕES EM PESQUISAS (Brasil) 4BIOCINESE CENTRO DE ESTUDOS BIOFARMACÉUTICOS (Brasil) IN VIVO CENTERS 1GRUPO CENTRALAB (Argentina) 2DOMÍNGUEZ LABORATORIO (Argentina) 3F.P. CLINICAL PHARMA S.R.L. (Argentina) 4ALKEM LABORATORIES LTD. (India) 5CENTRO DE ESTUDIOS CIENTIFICOS Y CLÍNICOS PHARMA S.A. DE C.V. (CECYC) (México) 6OM SAI CLINICAL RESEARCH PVT. LTD. (India) 7CENTRO DE BIOEQUIVALENCIA BIOPHADE CLINICAL RESEARCH. (BIOPHADE) (México) 8PIRAMAL CLINICAL RESEARCH LTD.PVT. (INDIA) 9SEMLER RESEARCH CENTER LTD. PVT. (INDIA)  Authorized centers by high sanitary vigilance agencies are accepted, ANVISA alone has certified 21 BE centers in Brazil and 38 overseas

8 Bioequivalence number 2013 year

9 APPLICATIONS RECEIVED FOR CERTIFICATION OF BE PRODUCTS Bioequivalence Total submission295 Registered products181 New applications114 number 61% 39%

10 Bioequivalence Total applicationsIn vivoIn vitro295 Registered prod New applications1140 number 22% IN VITRO APPLICATIONS RECEIVED FOR CERTIFICATION OF BE PRODUCTS ACCORDING TO THE STUDY TYPE 78% IN VIVO IN VIVO

11 Health problemdrugDrug products Cardiovascular 7 7 Metabolic 2 2 Central nervious system 3 3 HIV 12 Infective(AB) MAIN DRUGS Resolution 244/31-Jan-2011 – ISP Chile

12 THANKS!!! Instituto de Salud Pública de Chile