Publicação
Medicines registration in Portuguese-speaking African countries, focusing in the following countries: Angola, Cap Verde and Mozambique
| Resumo: | This work aims to present the regulation perspective on the medicines registration in PALOPs – Países Africanos de Língua Oficial Portuguesa (Portuguese‐speaking African countries), their regulatory requirements, constraints and opportunities, focusing on the following countries: Angola, Cape Verde and Mozambique. This thesis has as purpose to deepen and systematize knowledge with regard to the registration procedure of medicines in the selected countries. Regulatory perspective is framed in the context of the health sector and its development and national regulatory agencies in developing countries in Africa. The information used was gathered from the Ministry of Health Websites in each country and/or regulatory authority of medicines, international entities and bibliography regarding the PALOP and other African countries. Health systems existing in referred countries are subject to a SWOT analysis, with discussion of the strengths and improvement opportunities for each one. The regulatory authorities of developing countries in Africa face problems of lack of funding and human resources but there is an improvement effort by several countries including the adoption of legislation in order to ensure a tighter control of medicines that are placed on the market. The drug registration is a crucial process in the evaluation of medicinal products with the purpose to place them on the market, seeking to minimize the use of low quality drugs, ineffective or counterfeit. The authorities of developing countries face the challenge of evaluating drugs without prior evaluation by more experienced officials, and simultaneously requiring qualified personnel for this purpose. As a result have been observed in recent years efforts to implement procedures, adoption of international guidelines and training of qualified personnel. It has been adopted in some countries the registration process by recognition of the evaluation made by more experienced authorities. |
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| Autores principais: | Figueiredo, Alina Maria Moreira de |
| Assunto: | Biomedicina farmacêutica Indústria farmacêutica - Países de língua oficial portuguesa Medicamentos - Regulamentação |
| Ano: | 2015 |
| País: | Portugal |
| Tipo de documento: | dissertação de mestrado |
| Tipo de acesso: | acesso aberto |
| Instituição associada: | Universidade de Aveiro |
| Idioma: | inglês |
| Origem: | RIA - Repositório Institucional da Universidade de Aveiro |
| Resumo: | This work aims to present the regulation perspective on the medicines registration in PALOPs – Países Africanos de Língua Oficial Portuguesa (Portuguese‐speaking African countries), their regulatory requirements, constraints and opportunities, focusing on the following countries: Angola, Cape Verde and Mozambique. This thesis has as purpose to deepen and systematize knowledge with regard to the registration procedure of medicines in the selected countries. Regulatory perspective is framed in the context of the health sector and its development and national regulatory agencies in developing countries in Africa. The information used was gathered from the Ministry of Health Websites in each country and/or regulatory authority of medicines, international entities and bibliography regarding the PALOP and other African countries. Health systems existing in referred countries are subject to a SWOT analysis, with discussion of the strengths and improvement opportunities for each one. The regulatory authorities of developing countries in Africa face problems of lack of funding and human resources but there is an improvement effort by several countries including the adoption of legislation in order to ensure a tighter control of medicines that are placed on the market. The drug registration is a crucial process in the evaluation of medicinal products with the purpose to place them on the market, seeking to minimize the use of low quality drugs, ineffective or counterfeit. The authorities of developing countries face the challenge of evaluating drugs without prior evaluation by more experienced officials, and simultaneously requiring qualified personnel for this purpose. As a result have been observed in recent years efforts to implement procedures, adoption of international guidelines and training of qualified personnel. It has been adopted in some countries the registration process by recognition of the evaluation made by more experienced authorities. |
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