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Infarmed: Aprovada lista dos grupos homogéneos e dos preços de referência unitários – 4.º trimestre de 2019

A lista dos Grupos Homogéneos e dos preços de referência unitários a vigorar no 4.º trimestre de 2019 foi aprovada. Consulte a área Sistema de Preços de Referência, na página Avaliação de Tecnologias de Saúde, nomeadamente a Circular Informativa N.º 140/CD/100.20.200, de 12/09/2019 e a Deliberação N.º 76/CD/2019. Posted on the Infarmed website on 17 September 2019

2019-09-19T20:49:58+00:0019.09.2019|Regulatory Affairs|

FDA takes first action under new international collaboration with Australia and Canada designed to provide a framework for concurrent review of cancer therapies, approving treatment for patients with endometrial carcinoma

The U.S. Food and Drug Administration is announcing Project Orbis, an initiative of the FDA Oncology Center of Excellence (OCE). Project Orbis provides a framework for concurrent submission and review of oncology drugs among its international partners. Under this project, the FDA, the Australian Therapeutic Goods Administration (TGA) and Health Canada collaboratively reviewed applications for two [...]

2019-09-19T20:04:29+00:0019.09.2019|Drug Development Strategy, Regulatory Affairs|

EMA to provide guidance on avoiding nitrosamines in human medicines

EMA’s Executive Director has asked the human medicines committee (CHMP) to provide guidance for avoiding the presence of nitrosamine impurities in human medicines containing chemically synthesised active substances. 'We will continue to work with our partners to address the presence of nitrosamines and reassure patients about the quality of their medicines,' says the Executive Director Professor Guido [...]

Infarmed: Suspensão de atividades do distribuidor por grosso Nvn Iapharm Pharmaceuticals Ldt (Chipre)

A autorização de distribuição por grosso de medicamentos da entidade NVN IAPHARM PHARMACEUTICALS LDT foi suspensa após a deteção de não conformidades com as Boas Práticas de Distribuição, conforme divulgado pela Agência do Medicamento do Chipre. O relatório destas não conformidades pode ser consultado na base de dados de acesso público EudraGMDP, estando a suspensão [...]

2019-09-16T19:32:08+00:0016.09.2019|Regulatory Affairs|

FDA Statement on improving adverse event reporting of compounded drugs to protect patients

Compounded drugs can serve an important medical need for certain patients, however, they also present risksExternal Link Disclaimer to patients since they are not evaluated by the FDA for safety, effectiveness and quality. The FDA’s compounding program aims to help protect patients from poor-quality compounded drugs, while preserving access to lawfully-marketed compounded drugs for patients who have [...]

2019-09-12T21:50:02+00:0012.09.2019|Pharmacovigilance, Regulatory Affairs|

Infarmed: Disponibilidade do medicamento: regulamento em consulta pública

O Decreto-lei n.º 112/2019, recentemente publicado, reforça o dever geral de serviço público de fornecimento e dispensa de medicamentos e as obrigações de todos os intervenientes da cadeia do medicamento, atendendo ao princípio basilar de que a salvaguarda do acesso ao medicamento é um dever do Estado, bem como de todos aqueles que intervêm no [...]

2019-09-12T20:30:50+00:0012.09.2019|Regulatory Affairs|

FDA approves first treatment for patients with rare type of lung disease

The U.S. Food and Drug Administration today approved Ofev (nintedanib) capsules to slow the rate of decline in pulmonary function in adults with interstitial lung disease associated with systemic sclerosis or scleroderma, called SSc-ILD. It is the first FDA-approved treatment for this rare lung condition. “Patients suffering from scleroderma need effective therapies, and the FDA [...]

2019-09-12T20:21:43+00:0012.09.2019|Drug Development Strategy, Regulatory Affairs|

FDA sends warning to company for selling unapproved umbilical cord blood and umbilical cord products that may put patients at risk; continues to warn patients of the risk of unapproved stem cell therapy

The U.S. Food and Drug Administration has warned Stemell, Inc. (Stemell), of San Juan Capistrano, California, and its president and Chief Executive Officer, Peyman Taeidi, Ph.D., for manufacturing and distributing unapproved products derived from umbilical cord blood and umbilical cord and for significant deviations from current good tissue practice (CGTP) and current good manufacturing practice (CGMP) requirements, [...]

2019-09-11T11:07:36+00:0011.09.2019|Pharmacovigilance, Regulatory Affairs|

ANSM: Surdosage et overdose d’opioïdes: point sur l’offre thérapeutique de la naloxone en France

A l’occasion de l’Overdose Awareness Day ce samedi 31 août, l’Agence Nationale de Sécurité du Médicament et des produits de santé (ANSM) réalise un point de situation sur l’offre thérapeutique des antidotes aux opioïdes en France. L’ANSM a octroyé deux autorisations de mise sur le marché (AMM) pour des kits de naloxone prête à l’emploi: [...]

2019-09-10T20:23:47+00:0010.09.2019|Drug Development Strategy, Regulatory Affairs|

EMA: Global public meeting on draft ICH guideline on clinical trials

The global guidance for the conduct of clinical trials is currently undergoing a major revision. As part of the worldwide consultation process, the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is organising a public meeting to review its draft E8 (R1) Guideline ‘General Considerations for Clinical Trials’. EMA is encouraging its stakeholders to register [...]

2019-09-04T18:07:29+00:0004.09.2019|Drug Development Strategy, Regulatory Affairs|

FDA recommends health care facilities and manufacturers begin transitioning to duodenoscopes with disposable components to reduce risk of patient infection

Today, the U.S. Food and Drug Administration is recommending that duodenoscope manufacturers and health care facilities transition to different types of duodenoscopes that may pose less risk to patient safety. Specifically, because of challenges with cleaning these devices for reuse (reprocessing) and persistent high levels of contamination, the agency is recommending moving away from using duodenoscopes with [...]

2019-09-04T18:03:34+00:0004.09.2019|Regulatory Affairs|

ANSM: Cancer du sein: L’ANSM met à disposition deux nouveaux traitements innovants

Pour permettre un accès rapide et anticipé aux traitements innovants, l’ANSM a octroyé deux autorisations temporaires d’utilisation (ATU ) de cohorte à deux médicaments : Atezolizumab dans le traitement du cancer du sein triple négatif et Trastuzumab emtansine dans le traitement adjuvant  du cancer du sein de type HER2 positif avec une maladie résiduelle invasive. L’ANSM permet [...]

2019-09-03T17:00:57+00:0003.09.2019|Drug Development Strategy, Regulatory Affairs|

FDA approves new add-on drug to treat off episodes in adults with Parkinson’s disease

The U.S. Food and Drug Administration today approved Nourianz (istradefylline) tablets as an add-on treatment to levodopa/carbidopa in adult patients with Parkinson’s disease (PD) experiencing "off" episodes. An "off" episode is a time when a patient’s medications are not working well, causing an increase in PD symptoms, such as tremor and difficulty walking. "Parkinson’s disease is a [...]

2019-09-03T16:58:10+00:0003.09.2019|Drug Development Strategy, Regulatory Affairs|

Infarmed: Alterações ao Estatuto do Medicamento – Decreto-Lei n.º 112/2019, de 16 de agosto

No seguimento da entrada em vigor do Decreto-Lei n.º 112/2019, de 16 de agosto, que procedeu à décima segunda alteração ao Decreto-Lei n.º 176/2006, de 30 de agosto (Estatuto do Medicamento), destacam-se as seguintes alterações: Titulares de AIM Os titulares de autorização de introdução no mercado (TAIM), ou os seus representantes locais, estão dispensados de obter [...]

2019-09-03T16:48:06+00:0003.09.2019|Regulatory Affairs|

FDA warns company for putting consumers at risk with drug manufacturing data integrity violations

Today the U.S. Food and Drug Administration posted a warning letter to Ningbo Huize Commodity Co., an over-the-counter (OTC) drug manufacturer, for significant current good manufacturing practice (CGMP) violations, including data integrity issues. “Americans deserve to have confidence in the quality of drugs the FDA regulates – from the prescription medicines they take to the over-the-counter products [...]

2019-09-02T21:27:23+00:0002.09.2019|Quality System and Audit, Regulatory Affairs|

FDA approves new antibiotic to treat community-acquired bacterial pneumonia

The U.S. Food and Drug Administration today approved Xenleta (lefamulin) to treat adults with community-acquired bacterial pneumonia. “This new drug provides another option for the treatment of patients with community-acquired bacterial pneumonia, a serious disease,” said Ed Cox, M.D., M.P.H., director of FDA’s Office of Antimicrobial Products. “For managing this serious disease, it is important [...]

2019-09-02T21:20:49+00:0002.09.2019|Drug Development Strategy, Regulatory Affairs|

(Cas) La AEMPS informa de que los desfibriladores externos automáticos fabricados por Defiteq International B.V. o GGT Holding B.V. tienen un marcado CE falso

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 AEMPS informa de que los desfibriladores externos automáticos (DEA) modelos Telefunken “HR1” y “FA1” y HeartReset, fabricados por Defiteq International B.V., Holanda, o [...]

2019-08-13T19:20:58+00:0013.08.2019|Pharmacovigilance, Regulatory Affairs|

(Cas) AEMPS: Boletín mensual de la AEMPS sobre medicamentos de uso humano del mes de junio de 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 nuevos medicamentos, cambios de especial interés en medicamentos ya autorizados, información sobre seguridad y otra información de interés. En la sección [...]

(Cas) AEMPS: Información sobre la venta de medicamentos a través de sitios web y aplicaciones para móviles

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 sobre la venta de medicamentos a través de sitios web y [...]

2019-08-12T19:59:26+00:0012.08.2019|Pharmacovigilance, Regulatory Affairs|