> Regulatory Affairs

Infarmed: Dados relativos aos processos de financiamento concluídos no 1.º trimestre de 2019

A conclusão de processos de financiamento relativos a novos medicamentos (novas substâncias ativas ou novas indicações terapêuticas) aumentou significativamente no 1.º trimestre de 2019, essencialmente na área da Oncologia. Dos 22 processos concluídos, 10 foram aprovados para financiamento pelo Serviço Nacional de Saúde (SNS), quer para utilização em meio hospitalar quer em ambulatório. Destaca-se também [...]

2019-05-26T12:28:36+00:0026.05.2019|Regulatory Affairs|

(Cas) AEMPS: Información a los laboratorios titulares de Medicamentos de Uso Humano que contienen antagonistas del receptor de angiotensina-II (sartanes) con un grupo tetrazol: “candesartán, irbesartán, losartán, olmesartán y valsartán” (Nº EMA: EMEA/H/A-31/1471) – Actualización del procedimiento específico de implementación

Sorry, this entry is only available in European Spanish. For the sake of viewer convenience, the content is shown below in the alternative language. You may click the link to switch the active language. La Agencia Española de Medicamentos y Productos Sanitarios (AEMPS) informa de la publicación en su página web de la ACTUALIZACIÓN DEL [...]

2019-05-26T13:08:46+00:0026.05.2019|Regulatory Affairs|

Infarmed: Novo medicamento para adultos diabéticos (Tresiba – Insulina degludec – Avaliação da comparticipação concluída)

O medicamento Tresiba (Insulina degludec) obteve autorização de comparticipação na indicação: Tratamento da diabetes mellitus tipo 1, em adultos. Na fase de avaliação farmacoterapêutica o medicamento Tresiba (insulina degludec) apresentou valor terapêutico acrescentado não quantificável em relação à insulina glargina, na população de doentes adultos com DM tipo 1. Na avaliação económica, os valores custo-efetividade [...]

2019-05-24T19:50:46+00:0025.05.2019|Drug Development Strategy, Regulatory Affairs|

Infarmed: Tratamento de mieloma múltiplo com novo medicamento (Darzalex – daratumumab – Avaliação prévia hospitalar concluída)

O medicamento Darzalex (daratumumab) obteve autorização para ser utilizado em meio hospitalar na indicação: Em combinação com bortezomib a e dexametasona no tratamento de doentes adultos com mieloma múltiplo que tenham recebido pelo menos uma terapêutica anterior, nos seguintes grupos de doentes: Doentes com idade ≤ 75 anos e tratados previamente com menos de 3 [...]

2019-05-25T11:02:35+00:0025.05.2019|Regulatory Affairs|

EMA: Update of EU recommendations for 2019–2020 seasonal flu vaccine composition

EMA has issued an  update of the EU recommendations for the influenza virus strains that vaccine manufacturers should include in vaccines for the prevention of seasonal influenza from autumn 2019. The recommendations now also contain a decision on suitable H1N1 and H3N2 viruses for seasonal live attenuated influenza vaccines (LAIV). The list of reagents for vaccine standardisation [...]

2019-05-24T21:34:01+00:0024.05.2019|Drug Development Strategy, Regulatory Affairs|

Infarmed: Lista de grupos homogéneos e preços de referência atualizada

No âmbito do Sistema de Preços de Referência, a lista dos grupos homogéneos e dos preços de referência unitários, a vigorar no 2.º trimestre de 2019, foi atualizada. Consulte a área Sistema de Preços de Referência, na página Comparticipação, nomeadamente a Circular Informativa N.º 87/CD/100.20.200, de 16/05/2019 e a Deliberação N.º 43/CD/2019. Posted on the Infarmed website on 16 [...]

2019-05-21T20:54:17+00:0021.05.2019|Regulatory Affairs|

FDA approves first anticoagulant (blood thinner) for pediatric patients to treat potentially life-threatening blood clots

The U.S. Food and Drug Administration today approved Fragmin (dalteparin sodium) injection, for subcutaneous use, to reduce the recurrence of symptomatic venous thromboembolism (VTE) in pediatric patients one month of age and older. VTE can include deep vein thrombosis (blood clot in the deep veins of the leg) and pulmonary embolism (blood clot in the [...]

2019-05-21T20:48:54+00:0021.05.2019|Drug Development Strategy, Regulatory Affairs|

Infarmed: Implementação das obrigações legais no que respeita aos dispositivos de segurança

A implementação da Diretiva 2011/62/EU, “Diretiva dos Medicamentos Falsificados” e do Regulamento Delegado (UE) 2016/161, da Comissão, de 2 de outubro de 2015, pelos estados membros da União Europeia alterou significativamente o circuito do medicamento, não só pela obrigatoriedade de colocação de dispositivos de segurança nas embalagens de determinados medicamentos, permitindo a deteção de medicamentos [...]

2019-05-15T21:24:42+00:0015.05.2019|Regulatory Affairs|

ANSM: Cannabis à visée thérapeutique en France: Les experts poursuivent leurs travaux sur les modalités de mise à disposition

Le Comité d’experts, créé par l’ANSM, sur le cannabis à visée thérapeutique en France va se réunir à nouveau le 15 mai afin de poursuivre ses travaux sur les modalités de mise à disposition dans le cadre de la phase expérimentale. Le comité se réunit le 15 mai avec pour objectif de poursuivre le recueil [...]

2019-05-15T21:16:42+00:0015.05.2019|Regulatory Affairs|

FDA warns manufacturers of products labeled as homeopathic for putting consumers at risk with significant violations of manufacturing quality standards

The U.S. Food and Drug Administration has posted warning letters to five companies who produce products labeled as homeopathic for significant violations of current good manufacturing practice (CGMP) regulations. Four of the warning letters pertain to companies who jointly produced a product labeled as homeopathic that posed a significant safety risk to consumers because their [...]

2019-05-14T20:08:32+00:0014.05.2019|Regulatory Affairs|

(Cas) AEMPS: Decisión (UE) 2019/701 de la Comisión de 5 de abril de 2019 de los Reglamentos, Decisiones y Directrices de la Comisión para la aplicación del Reglamento (CE) Nº 1223/2009

Sorry, this entry is only available in European Spanish. For the sake of viewer convenience, the content is shown below in the alternative language. You may click the link to switch the active language.La Agencia Española de Medicamentos y Productos Sanitarios ha publicado en su página web la Decisión (UE) 2019/701 de la Comisión de 5 [...]

2019-05-12T14:21:01+00:0012.05.2019|Regulatory Affairs|

Infarmed publica estudo sobre anti-histamínicos

Um anti-histamínico é um fármaco que é normalmente utilizado para alivio de alergias no tratamento de reações de hipersensibilidade. O estudo agora publicado revela que a utilização de anti-histamínicos aumentou durante todo o período de análise apresentado. Apesar de se observar um ligeiro decréscimo em 2017, em 2018 voltou a aumentar, atingindo 6,3 milhões de [...]

2019-05-12T14:39:42+00:0012.05.2019|Drug Development Strategy, Regulatory Affairs|

ANSM: Grossistes-répartiteurs: l’ANSM prend des mesures à l’encontre des “short-liners”

Face aux enjeux des ruptures de stock et aux risques d’introduction de médicaments falsifiés dans le circuit légal, l’ANSM a poursuivi en 2018 ses actions vis-à-vis des grossistes-répartiteurs. Les inspections, conduites par les Agences Régionales de Santé (ARS) en lien avec l’ANSM, ont mis en évidence qu’il existe encore des grossistes-répartiteurs qui ne remplissent pas [...]

2019-05-09T22:40:51+00:0009.05.2019|Quality System and Audit, Regulatory Affairs|

FDA approves first treatment for children with Lambert-Eaton myasthenic syndrome, a rare autoimmune disorder

The U.S. Food and Drug Administration today approved Ruzurgi (amifampridine) tablets for the treatment of Lambert-Eaton myasthenic syndrome (LEMS) in patients 6 to less than 17 years of age. This is the first FDA approval of a treatment specifically for pediatric patients with LEMS. The only other treatment approved for LEMS is only approved for [...]

2019-05-08T20:26:33+00:0008.05.2019|Drug Development Strategy, Regulatory Affairs|

FDA approves new treatments for heart disease caused by a serious rare disease, transthyretin mediated amyloidosis

On May 3, the U.S. Food and Drug Administration approved Vyndaqel (tafamidis meglumine) and Vyndamax (tafamidis) capsules for the treatment of the heart disease (cardiomyopathy) caused by transthyretin mediated amyloidosis (ATTR-CM) in adults. These are the first FDA-approved treatments for ATTR-CM. Vyndaqel and Vyndamax have the same active moiety, tafamidis, but they are not substitutable [...]

2019-05-08T20:14:32+00:0008.05.2019|Drug Development Strategy, Regulatory Affairs|

ANSM: Avis et recommandations du Comité des médicaments pédiatriques (PDCO) de l’Agence européenne des médicaments (EMA) – Réunion du 26 – 29 Mars 2019

Ce Comité est chargé notamment de l’évaluation des PIPs (Plans d’Investigations Pédiatriques) qui encadrent les programmes de développement en qualité, préclinique et clinique des médicaments destinés à la population pédiatrique (de la naissance à 17 ans inclus), ainsi que des dérogations et reports de développement en pédiatrie. Le PDCO vérifie la réalisation du programme d’études [...]

2019-05-08T20:05:45+00:0008.05.2019|Drug Development Strategy, Regulatory Affairs|

FDA: First FDA-approved vaccine for the prevention of dengue disease in endemic regions

The U.S. Food and Drug Administration announced today the approval of Dengvaxia, the first vaccine approved for the prevention of dengue disease caused by all dengue virus serotypes (1, 2, 3 and 4) in people ages 9 through 16 who have laboratory-confirmed previous dengue infection and who live in endemic areas. Dengue is endemic in [...]

2019-05-07T20:05:30+00:0007.05.2019|Drug Development Strategy, Regulatory Affairs|

(Cas) AEMPS: Boletín trimestral de la AEMPS sobre productos sanitarios y cosméticos Enero – Marzo 2019

Sorry, this entry is only available in European Spanish. For the sake of viewer convenience, the content is shown below in the alternative language. You may click the link to switch the active language.Recoge información sobre la evolución de la legislación de estos productos, los documentos técnicos y científicos publicados, las actuaciones de vigilancia y [...]

FDA approves first treatment for all genotypes of hepatitis C in pediatric patients

The U.S. Food and Drug Administration today approved Mavyret (glecaprevir and pibrentasvir) tablets to treat all six genotypes of hepatitis C virus (HCV) in children ages 12 to 17. Mavyret was previously approved to treat HCV in adults in 2017. “Direct-acting antiviral drugs reduce the amount of HCV in the body by preventing the virus from [...]

2019-05-07T19:43:56+00:0007.05.2019|Drug Development Strategy, Regulatory Affairs|