Home > Regulatory Affairs

(Cas) AEMPS: Recomendaciones para desarrollar el potencial del big data para la salud pública en la UE

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. El grupo de trabajo conjunto sobre big data formado por expertos de la Agencia Europea de Medicamentos (EMA) y Jefes de Agencias de [...]

2020-01-22T21:41:54+00:0022.01.2020|Drug Development Strategy, Regulatory Affairs|

EMA: Ten recommendations to unlock the potential of big data for public health in the EU

The joint Big Data Task Force of EMA and the Heads of Medicines Agencies (HMA) proposes ten priority actions for the European medicines regulatory network to evolve its approach to data use and evidence generation, in order to make best use of big data to support innovation and public health, in a report published today . Big data are extremely large, rapidly [...]

2020-01-22T20:40:25+00:0022.01.2020|Drug Development Strategy, Regulatory Affairs|

(Cas) AEMPS: Boletín mensual de la AEMPS sobre medicamentos de uso humano del mes de noviembre 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 [...]

Infarmed: Atualização da lista de grupos homogéneos e preços de referência

No âmbito do Sistema de Preços de Referência, a lista dos grupos homogéneos e dos preços de referência unitários, a vigorar no 4.º trimestre de 2019, foi atualizada. Consulte a área Sistema de Preços de Referência, na página Comparticipação, nomeadamente a Circular Informativa N.º 16/CD/100.20.200, de 09/01/2020 e a Deliberação N.º 03/CD/2020. Posted on the Infarmed website on 15 [...]

2020-01-19T19:35:30+00:0019.01.2020|Regulatory Affairs|

ANSM: BCG thérapie dans le traitement des tumeurs de la vessie: précisions sur les critères d’attribution des flacons

Information actualisée le 14 janvier 2020 Compte tenu des difficultés d’approvisionnement en BCG thérapie dans le traitement des tumeurs de la vessie, et afin de réserver les unités disponibles aux patients dont le besoin est le plus urgent, en accord avec l’ANSM et l’AFU, le laboratoire Medac met en place un contingentement exceptionnel et temporaire [...]

2020-01-19T19:32:19+00:0019.01.2020|Regulatory Affairs|

Infarmed: Esclerose múltipla com novo medicamento (Ocrevus – DCI: ocrelizumab – Avaliação prévia hospitalar concluída)

O medicamento Ocrevus (DCI: ocrelizumab) obteve autorização para ser utilizado em meio hospitalar na indicação: Tratamento de doentes adultos com esclerose múltipla por surtos (EMS) com doença ativa, definida clínica ou imagiologicamente; Tratamento de doentes adultos com esclerose múltipla progressiva primária (EMPP) inicial em termos e duração da doença e nível de incapacidade, e com [...]

2020-01-12T12:55:55+00:0013.01.2020|Regulatory Affairs|

Infarmed: Novo medicamento na profilaxia da reativação da doença por CMV em adultos (Prevymis – Letermovir – Avaliação prévia hospitalar concluída)

O medicamento Prevymis (Letermovir) obteve autorização para ser utilizado em meio hospitalar na indicação: Profilaxia da reativação da doença por citomegalovírus (CMV) em adultos CMV-positivos submetidos a transplante alogénico de células estaminais hematopoiéticas (TCEH). Concluiu-se que o letermovir demonstrou valor terapêutico não quantificável na profilaxia da reativação da doença por CMV em adultos CMV positivos [...]

2020-01-12T12:48:17+00:0013.01.2020|Regulatory Affairs|

Infarmed: Orientações europeias dirigidas a fabricantes de dispositivos médicos da classe I

No passado dia 18 de dezembro de 2019 foi publicado, pela Comissão Europeia, o documento "MDCG 2019-15 Guidance notes for manufacturers of Class I medical device" relativo às orientações dirigidas a fabricantes para a colocação no mercado de dispositivos médicos de classe I. Esta publicação resultou da revisão e atualização das anteriores orientações já existentes, à luz do [...]

2020-01-12T12:39:01+00:0012.01.2020|Quality System and Audit, Regulatory Affairs|

FDA approves the first targeted therapy to treat a rare mutation in patients with gastrointestinal stromal tumors

Today, the U.S. Food and Drug Administration approved Ayvakit (avapritinib) for the treatment of adults with unresectable (unable to be removed with surgery) or metastatic (when cancer cells spread to other parts of the body) gastrointestinal stromal tumor (GIST) – a type of tumor that occurs in the gastrointestinal tract, most commonly in the stomach [...]

2020-01-12T12:31:30+00:0012.01.2020|Drug Development Strategy, Regulatory Affairs|

EMA Human medicines: highlights of 2019

EMA has published an overview of its key recommendations in 2019 on the authorisation and safety monitoring of medicines for human use. Innovative medicines are essential to advancing public health as they bring new opportunities to treat certain diseases. In 2019, EMA recommended 66 medicines for marketing authorisation. Of these, 30 had a new active substance which had never been authorised [...]

FDA approves first generics of Eliquis

The U.S. Food and Drug Administration has approved two applications for the first generics of Eliquis (apixaban) tablets to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation. Apixaban is also indicated for the prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE), in patients who [...]

2020-01-07T20:57:25+00:0007.01.2020|Drug Development Strategy, Regulatory Affairs|

FDA approves new treatment for adults with migraine

The U.S. Food and Drug Administration today approved Ubrelvy (ubrogepant) tablets for the acute (immediate) treatment of migraine with or without aura (a sensory phenomenon or visual disturbance) in adults. Ubrelvy is not indicated for the preventive treatment of migraine. It is the first drug in the class of oral calcitonin gene-related peptide receptor antagonists [...]

2020-01-07T20:48:46+00:0007.01.2020|Drug Development Strategy, Regulatory Affairs|

FDA Guidance for Industry: Recommended Content and Format of Non-Clinical Bench Performance Testing Information in Premarket Submissions

The Food and Drug Administration (FDA) has developed this document to describe relevant information that should be included in test report summaries, test protocols and complete test reports for non-clinical bench performance testing provided in a premarket submission (i.e., premarket approval (PMA) applications, humanitarian device exemption (HDE) applications, premarket notification (510(k)) submissions, investigational device exemption (IDE) applications, [...]

2019-12-30T17:30:35+00:0030.12.2019|Regulatory Affairs, Training|

FDA Guidance for Industry: Submitting Study Datasets for Vaccines to the Office of Vaccines Research and Review

This technical specifications document provides you, sponsor/applicant detailed information and specifications for the content of datasets submitted to FDA’s Center for Biologics Evaluation and Research (CBER) Office of Vaccines Research and Review (OVRR) and is designed to aid clinical and statistical reviewers in the review of vaccine applications, e.g., biologics license applications.  We, FDA, recommend [...]

2019-12-30T17:25:47+00:0030.12.2019|Regulatory Affairs, Training|

(Cas) AEMPS: Nueva información sobre nitrosaminas para titulares de autorizaciones de comercialización: Evaluación del riesgo de la presencia de impurezas de nitrosamina en todos los medicamentos de uso humano de síntesis química

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 de una actualización del documento de preguntas y respuestas: [...]

2019-12-30T14:36:06+00:0030.12.2019|Regulatory Affairs|

FDA approves new treatment option for patients with HER2-positive breast cancer who have progressed on available therapies

Today, the U.S. Food and Drug Administration granted accelerated approval to Enhertu (fam-trastuzumab deruxtecan-nxki) for the treatment of adults with unresectable (unable to be removed with surgery) or metastatic (when cancer cells spread to other parts of the body) HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens in the metastatic setting. [...]

2019-12-30T14:27:43+00:0030.12.2019|Drug Development Strategy, Regulatory Affairs|

EMA Management Board: highlights of December 2019 meeting

The December meeting of EMA’s Management Board was hosted by the Dutch government as the Agency’s interim building is now closed to prepare for the move to the new EMA building in Amsterdam Zuidas in January 2020. The move to the final building opens a new chapter for EMA and will allow the Agency to fully refocus [...]

FDA takes efforts to improve quality of compounded drugs from outsourcing facilities through collaboration and education as part of new Center of Excellence

Compounded drugs can serve an important role in meeting patients’ medical needs that cannot be met by an FDA-approved drug. Outsourcing facilities, a significant part of the industry producing compounded drugs used by hospitals, clinics, providers, and other health care systems, have rapidly evolved since the passage of the Drug Quality and Security Act (DQSA) in [...]

2019-12-28T12:18:46+00:0028.12.2019|Quality System and Audit, Regulatory Affairs|

First FDA-approved vaccine for the prevention of Ebola virus disease, marking a critical milestone in public health preparedness and response

The U.S. Food and Drug Administration announced today the approval of Ervebo, the first FDA-approved vaccine for the prevention of Ebola virus disease (EVD), caused by Zaire ebolavirus in individuals 18 years of age and older. Cases of EVD are very rare in the U.S., and those that have occurred have been the result of [...]

2019-12-28T12:12:35+00:0028.12.2019|Drug Development Strategy, Regulatory Affairs|

FDA approves new type of therapy to treat advanced urothelial cancer

Today, the U.S. Food and Drug Administration granted accelerated approval to Padcev (enfortumab vedotin-ejfv), a Nectin-4-directed antibody and microtubule inhibitor conjugate, meaning the drug specifically targets cancer cells – in this case, the cell adhesion molecule Nectin-4, which is highly expressed in urothelial cancers. Padcev is indicated for the treatment of adult patients with locally [...]

2019-12-27T14:51:02+00:0027.12.2019|Drug Development Strategy, Regulatory Affairs|