[pt] vO objetivo da dissertação é propor um modelo de autoavaliação para empresas farmacêuticas no Brasil, que possa ser utilizado para verificar sua capacidade em relação ao cumprimento das diretrizes e requisitos das Boas Práticas de Fabricação (BPF) de Medicamentos no Brasil, segundo a RDC número 301/2019 da Anvisa. Busca-se demonstrar a aplicabilidade do modelo mediante o desenvolvimento de um estudo empírico em uma empresa farmacêutica selecionada para este propósito. A pesquisa pode ser considerada aplicada, descritiva e metodológica. Quanto aos meios de investigação, a metodologia compreende: (i) pesquisa bibliográfica e análise documental sobre os temas centrais da pesquisa; (ii) construção da estrutura analítica hierárquica em alinhamento aos requisitos e itens da RDC número 301/2019 da Anvisa; (iii) aplicação do método Analytic Hierarchy Process (AHP) para definição dos pesos dos requisitos e itens da RDC número 301/2019; (iv) definição e aplicação do instrumento de autoavaliação junto ao Gerente Industrial da empresa selecionada para o estudo empírico e apuração do nível da capacidade da empresa quanto ao cumprimento de cada requisito/item da RDC número 301/2019; e (v) emprego do método Importance-Performance Analysis (IPA) para identificação dos requisitos/itens que devam ser priorizados em um plano de ação, visando a obtenção do certificado de BPF de medicamentos pela Anvisa. Destaca-se como resultado principal desta dissertação uma sistemática inovadora de autoavaliação de empresas farmacêuticas, na perspectiva de apoiar processos decisórios referentes à certificação dessas empresas segundo a RDC número 301/2019 da Anvisa. / [en] The dissertation aims to propose a self-assessment model for pharmaceutical firms that can verify their capacity to meet the requirements established in the Anvisa RDC n. 301/2019, concerned with the Good Manufacturing Practices for Pharmaceutical Products. It seeks to demonstrate the model s applicability by developing an empirical study in a pharmaceutical company selected for this purpose. The methodology comprises: (i) literature review and documentary analysis on the central research themes; (ii) definition of the analytical structure based on the Analytic Hierarchy Process (AHP) method, aligned with Good Manufacturing Practices (GMP) for Pharmaceutical Products; (iii) application of the AHP method for assigning weights to the requirements of Anvisa RDC n. 301/2019; (iv) application of the self-assessment instrument addressed to the Industrial Manager of the mentioned pharmaceutical firm and determination of its capacity level to meet each requirement/item of the RDC; and (v) employment of the Importance-Performance Analysis (IPA) method to identify requirements that should be prioritized aiming future certification by Anvisa. An innovative self-assessment model based on Good Manufacturing Practices for Pharmaceutical Products stands out as the main result of this dissertation. It can support decision-making processes related to the certification of pharmaceutical firms by Anvisa.

La thèse démontre que l'environnement protectionniste en Inde a contribué à bâtir une industrie pharmaceutique solide. L'arrivée simultanée de l'Accord ADPIC et de la libéralisation économique a créé des « push factors » à la fois compétitifs et favorables, obligeant les firmes pharmaceutiques indiennes (FPI) à chercher de nouvelles voies de croissance à l’étranger. Les politiques des pays africains en faveur des génériques, l’action des organisations internationales et la nouvelle gouvernance des marchés financés par les bailleurs de fonds ont aussi induits des « pull factors » permettant aux FPI de s'engager davantage sur ces marchés. Cette thèse montre à travers le cas du Mali que le marché en Afrique de l’Ouest francophone est divisé en quatre segments – le marché public financé par l'État et par des donateurs et le marché privé formel et informel – avec des réglementations différentes. Les FPI n'utilisent que l'exportation dans ces pays, mais leurs organisations varient selon le segment dans lequel elles souhaitent opérer. Enfin, ce travail utilise l’étude du Synriam, un nouvel antipaludéen pour montrer que Ranbaxy a utilisé le partenariat avec Medicines for Malaria Venture pour développer ses capacités, accéder à de nouveaux marchés et gagner en légitimité. Cette étude met en évidence que les organisations internationales peuvent créer des barrières institutionnelles et influencer les stratégies d'entrée des firmes. En conclusion, cette thèse illustre la richesse et la complexité du marché pharmaceutique africain et démontre également que les stratégies d'entrée sur le marché et d'exploitation des FPI sont influencées par l'environnement institutionnel sous-jacent. / This dissertation first shows that the early protectionist environment in India helped build a robust indigenous pharmaceutical industry. The simultaneous arrival of TRIPS and economic liberalization created both competitive and supportive push factors forcing Indian firms to look for new avenues of growth beyond national boundaries. Generic supporting policies of African countries, the action of international organizations and the new governance of donor-funded markets also acted as pull factors for Indian firms to engage in these markets.Next, taking the case of Mali, the thesis shows that the pharmaceutical market in Francophone West African countries is divided into four specific segments – government and donor-funded public and formal and informal private markets – with different regulatory characteristics. Indian firms are using only export to operate in these countries, but the organization of export varies according to the segment in which a firm intends to operate. Lastly, it takes the case of Synriam, a new antimalarial to show that Ranbaxy used the partnership with Medicines for Malaria Venture for developing capabilities, accessing new markets and gaining legitimacy. The case also reflects that international organizations may create institutional barriers and influence the market entry strategy of firms. To conclude, this thesis illustrates the richness and complexities of the African pharmaceutical market and shows that market entry and operation strategies of Indian firms are influenced by the underlying institutional environment.