ANVISA - Enhancing marketing authorization of drugs and medical devices in accordance to the international best practices

ANVISA - Enhancing marketing authorization of drugs and medical devices in accordance to the international best practices Balbiana Verazez Sampaio Oliveira

AGENDA 1. Strategic Plan 2016-2019 objectives and projects related to marketing authorization of drugs and medical devices. 2. Regulatory framework - recent changes (2014-2016). 3. International Regulatory Convergence and Cooperation 4. Final Remarks

STRATEGIC PLAN 2016-2019 The review began in the second half of 2015. Assessment - understanding of the current internal and external environments. Strategic Map 2016-2019 objectives and strategic portfolio of projects. Review of the mission, vision and value. Reformulation of the value chain.

ANVISA: Mission, Vision and Institutional Values Mission To protect and promote the health of the population, intervening the risks associated with production and use of products and services subject to health regulation, in a coordinated and integrated action within the National Health System (SUS) Vision To be nationally and internationally recognized as an institution that promotes health, citizenship and development, operating in an efficient and transparent manner, demonstrating itself as a leader in the field of regulation and health control Institutional Values Ethics and responsibility as public agent Capacity of articulation and integration Excellence in managing with its focus on results Knowledge as a source for action Transparency

VALUE CHAIN Management of Premarket Activities Management of Postmarket Activities Value Good Manufacturing Practice Certification and Business Authorization Authorization for Goods and Services Reduction of health risk in the release of new services and goods Fiscalization of Goods and Services Health Control for Foreign Trade and Border Crossing Points Monitoring of Goods and Services Market Monitoring and Economic Advisory Compliance with regulatory rules Health risk mitigation Reduction in irregular and failed access to products Protection and promotion of the population s health Demand Citizens Governance Strategic Management Support to Organizational Management Regulation Management Brazilian Health Regulatory System Coordination Institutional Relations Health Professionals Regulated Sectors

STRATEGY MAP 2016-2019 RESULTING OBJECTIVES 1. Increase the population s SAFE ACCESS to goods and services subject to health regulation 2. Improve REGULATORY FRAMEWORK for health ENABLING OBJETIVES 3. Optimize PREMARKET ACTIVITIES based on health risk assessment 4. Improve POSTMARKET SURVEILLANCE ACTIVITIES, focusing on control and monitoring 5. Strengthen the coordination activities of the BRAZILIAN HEALTH REGULATION SYSTEM 6. Increase the EFFICIENCY of operations in PORTS, AIRPORTS AND BORDERS 7. Improve the activities of INTERNATIONAL COOPERATION and REGULATORY CONVERGENCE 8. Implement a GOVERNANCE model that encourages integration, innovation, and institutional development* 9. Strengthen the activities of EDUCATION AND COMMUNICATION in health regulation and the model of institutional relations ** * Considering human resources, management dynamics, infrastructure, information systems, and internal communication. **Citizens, health professionals, the regulated sector, other governmental agencies, the legislative power, the judiciary, civil society organizations, and others.

STRATEGIC INDICATORS - 2016-2019 Strategic Objective 3. Optimize premarket activities based on health risk assessment 3.1 Average time for registration, for object 3.2 Percentage of requests of products registration with simplified process 3.3 Time spent by Anvisa to make inspections in drugs manufacturers located in other countries 3.4 Time spent by Anvisa to make inspections in medical devices manufacturers located in other countries

STRATEGIC INDICATORS - 2016-2019 Strategic Objective 7. Improve the activities of international cooperation and regulatory convergence 7.1 Percentage of convergence among ANVISA s regulatory instruments with standards, guidelines or International references MDSAP 7.2 Percentage of Auditors Bodies authorized in scope of Medical Device Single Audit Program (MDSAP) internalized by Anvisa within the deadline 7.3 Percentage of participation of MDSAP in International certification of medical devices 7.4 Anvisa s Internationalization Degree

ANVISA Strategic Portfolio of Projects Projects - 2016/2019 1. Improvement of registration procedures of products subject to health regulation based on international best practices 2. Improvement of health inspection procedures and Good Manufacturing Practices (GMP) certification of GMP based on international best practices 3. Reformulation of models and work processes in ports, airports, borders and customs areas 4. Strengthening postmarket surveillance model 5. Improving the impact assessment methodologies (ex ante and ex post) and the regulatory stock 6. Expansion of consistency and transparency in the issue of technical requirements practices 7. Development of an analytical model of health risks 8. Improvement of health regulatory action for health services 9. Restructuring the network model of laboratories for regulatory action 10. Harmonization of duties and procedures and establishing flows to the Brazilian Health Regulation System (SNVS) practices 11. Construction and implementation of the strategic agenda for the modernization and expansion of the Brazilian Health Regulation System (SNVS) effectiveness 12. Preparation of the learning path of Anvisa professional, following the competency-based management model 13. Restructuring the IT governance model

ANVISA Strategic Portfolio of Projects Projects - 2016/2019 1. Improvement of registration procedures of products subject to health 2. Improvement of health inspection procedures and Good Manufacturing Practices (GMP) certification of GMP based regulation international based best on practices international best practices 3. Reformulation of models and work processes in ports, airports, borders and customs areas 4. Strengthening postmarket surveillance model 5. Improving the impact assessment methodologies (ex ante and ex post) and the regulatory stock 7. 6. Development Expansion of an analytical of consistency model of health and risks transparency in the issue of technical requirements practices 8. Improvement of health regulatory action for health services 9. Restructuring the network model of laboratories for regulatory action 10. Harmonization of duties and procedures and establishing flows to the Brazilian Health Regulation System (SNVS) practices 11. Construction and implementation of the strategic agenda for the modernization and expansion of the Brazilian Health Regulation System (SNVS) effectiveness 12. Preparation of the learning path of Anvisa professional, following the competency-based management model 13. Restructuring the IT governance model

P1 IMPROVEMENT OF REGISTRATION PROCEDURES OF PRODUCTS SUBJECT TO HEALTH REGULATION BASED ON INTERNATIONAL BEST PRACTICES Objective To improve the products registration process, considering regulatory pratices adopted by other bodies with similar object of action and pratices already adopted internally by the Agency, in order to provide greater celerity and transparency to the products registration process and valuing the quality assurance principles, safety and efficacy of products subjected to health regulation. Escope Benchmarking actions on registration seeking for better pratices. To identify subjects with opportunity to increase convergence. Redesign of processes focus on sanitary risk. Disclosure of data, BI. Waiting results Reduction of time, increasing of products scope with simplified rite, increase of regulatory convergence.

P6 EXPANSION OF CONSISTENCY AND TRANSPARENCY IN THE ISSUE OF TECHNICAL REQUIREMENTS PRACTICES Objective To improve actions and adopt necessary measures to increasing consistency and transparency related to technical requirements emission practices during the process of registration analisis of products subject to health regulation, in order to contribute to work processes efficiency and the agility of registration processes. Escope Definition of the most common requirements reasons and the reasons of processual instruction faillure. Actions of qualification and improvement of technical analisis, and understanding standardization. Actions of interaction with the regulated sector to promote improvements on dossiers creation and the presentation of mandatory documents (Guidelines, Workshops, Check-lists). Waiting results Reduction of volume, variability and effort (internal and external).

REGULATORY FRAMEWORK: DRUG REGISTRATION 2014 - Anvisa reviewed the resolutions for registration for synthetic drugs: new drugs, similar and generics: one unique resolution was construct to the three categories harmonizing the administrative and quality requirements. the quality part of the dossier was reformulated based on CTD requirements. reviewed the criteria to the registration new drug intended for preventing or treating severely life-threatening or highly debilitating diseases, as long as an unmet medical need. Registration of New Drugs RDC Nº 60/2014.

REGULATORY FRAMEWORK: CLINICAL TRIALS The resolution was reviewed in 2015 - main objectives: increase the convergence with international regulatory framework, optimization of the working procedures, reduction of deadlines, increase predictability, provide more robust evidence for the registration process. Contribute to promote the development of research in the national territory! Approval for clinical trials with drugs RDC N 9, february/2015. Approval for clinical trials with medical devices RDC N 10, february/2015

REGULATORY FRAMEWORK: MEDICAL DEVICE PRE MARKET ACTIVITIES RDC nº 36/2015 - Defines the risk classification, registration and notification control rules and labeling requirements for in vitro diagnostis devices, including their instruments. RDC nº 40/2015 - Defines the requirements for medical devices notification. These regulations mean the implementation of the technical dossier for medical devices, according to IMDRF WG N9 e N13 documents (ToC). IN nº 04/2015 - Update of technical standards (ISO/IEC) regarding mandatory certification of electromedical equipments.

INTERNATIONAL REGULATORY COOPERATION AND CONVERGENCE Anvisa s perspectives on ongoing collaborative initiatives Enhance Anvisa s capabilities. Comparison of regulatory systems; Development of competencies. Equivalence on regulatory practices; Workshare. Think in a national and global way. Better use of limited resources; Reduce barriers to innovation; Promote access to new markets. Build confidence Understanding the assessment of each partner; Exchange knowledge and information.

INTERNATIONAL REGULATORY COOPERATION AND CONVERGENCE International Approach International Technical Cooperation 13 Formal Cooperation Agreement Brazilian Cooperation Agency Mainly Latin American Countries Regulatory Dialogue 35 MoUs, Agreements and Confidential Commitments Several Countries: USA, Canada, UK, Switzerland, Mexico, Japan, China, Korea, Australia, Argentina, Colombia, Cuba, Chile, France, Portugal, Sweden Forums of Regulatory Convergence

REGULATORY CONVERGENCE

FINAL REMARKS Strategic Plan 2016-2019 represent the directions for the next years. It s where Anvisa will put most of their efforts. Regulaty Agenda 2017-2020 the precedures for constructions were approved last week (27 of october). Regulatory Framework for Drugs: stability studies (review), analytic validation (review), simplified procedures for registration (new). Regulatory Framework for Medical Devices: reuse of medical devices (review). Public Consultation n 207/2016 Proposal to ban the manufacture and use of clinical thermometers and sphygmomanometers with mercury.

REGULATORY CONVERGENCE Arigatō! Obrigado! Thank you! Contact Brazilian Health Regulatory Agency Anvisa SIA Trecho 5 - Área especial 57 - Lote 200 Zip code: 71205-050 Brasília - DF Phone: + 55 61 3462 6000 www.anvisa.gov.br www.twitter.com/anvisa_oficial Anvisa Atende: 0800-642-9782 ouvidoria@anvisa.gov.br