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EMA: First treatment for rare condition primary hyperoxaluria type 1

EMA has recommended granting a marketing authorisation in the European Union for Oxlumo (lumasiran) for the treatment of primary hyperoxaluria type 1 (PH1). Primary hyperoxaluria is a rare inherited disorder characterised by the overproduction of oxalate. Oxalate can form calcium oxalate deposits, which can cause stones in the kidney and urinary tract (structures that carry urine) as [...]

2020-10-21T22:34:28+00:0021.10.2020|Drug Development Strategy, Regulatory Affairs|

EMA: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 12-15 October 2020

Ten new medicines recommended for approval EMA’s human medicines committee (CHMP) recommended ten medicines for approval at its October 2020 meeting. The Committee recommended granting a conditional marketing authorisation for Tecartus* (autologous anti-CD19-transduced CD3+ cells) for the treatment of adult patients with a rare cancer of white blood cells called mantle cell lymphoma. Since Tecartus addresses an unmet [...]

EMA: First CAR-T cell medicine for mantle cell lymphoma

EMA has recommended granting a conditional marketing authorisation in the European Union (EU) for Tecartus (autologous anti-CD19-transduced CD3+ cells) for the treatment of adult patients with a rare cancer of white blood cells called mantle cell lymphoma (MCL) when the symptoms or the disease come back (relapse) or when they are not responding (refractory) after two or more [...]

2020-10-20T16:14:38+00:0020.10.2020|Drug Development Strategy, Regulatory Affairs|

(Cas) AEMPS: Boletín trimestral de la AEMPS sobre productos sanitarios y cosméticos, julio – septiembre 2020

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 [...]

EMA cancer symposium: New approaches in patient-focused cancer medicine development

On Thursday, 29 October, EMA is hosting a symposium to discuss new approaches to facilitating and using input from cancer patients to inform medicine development and regulatory decision-making. The  agenda of the symposium , which will be held virtually due to the ongoing pandemic is available. The event can be followed via live broadcast on the event page. The [...]

2020-10-20T10:11:04+00:0020.10.2020|Drug Development Strategy, Regulatory Affairs|

UK medicines regulator joins up with Australia, Canada, Singapore and Switzerland regulators

The Medicines and Healthcare products Regulatory Agency (MHRA) is the latest regulator to join the Australia-Canada-Singapore-Switzerland (ACSS) Consortium. To accommodate the MHRA joining the group will now be known as the Access Consortium. The aim of the group is to provide patients with timely ‘access’ to high quality, safe and effective therapeutic products across the [...]

2020-10-20T09:49:19+00:0020.10.2020|Drug Development Strategy, Regulatory Affairs|

FDA Approves First Treatment for Ebola Virus

Today, the U.S. Food and Drug Administration approved Inmazeb (atoltivimab, maftivimab, and odesivimab-ebgn), a mixture of three monoclonal antibodies, as the first FDA-approved treatment for Zaire ebolavirus (Ebola virus) infection in adult and pediatric patients. “Today’s action demonstrates the FDA’s ongoing commitment to responding to public health threats—both domestically and abroad—on the basis of science and data,” [...]

2020-10-15T18:58:26+00:0015.10.2020|Drug Development Strategy, Regulatory Affairs|

Infarmed: Informação para os titulares de autorização de introdução no mercado: atualização do estado de comercialização

Para garantir a qualidade da informação disponibilizada aos cidadãos e aos profissionais de saúde, foi atualizada informação relativa ao estado de comercialização de cerca de 100 embalagens, a fim de que a mesma informação conste de forma correta, nomeadamente, nos sistemas de prescrição e dispensa.Neste sentido, os titulares de autorização de introdução no mercado (AIM) [...]

2020-10-14T22:30:52+00:0014.10.2020|Regulatory Affairs|

(Cas) La AEMPS, a través de la Red EAMI, celebra un encuentro con países iberoamericanos para compartir información sobre el acceso a la vacuna contra la COVID-19 en la región

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 objetivo de esta reunión es facilitar una acción conjunta y poner a disposición de los miembros de la Red EAMI [...]

2020-10-14T21:36:17+00:0014.10.2020|Drug Development Strategy, Regulatory Affairs|

(Cas) AEMPS: La EMA inicia la evaluación de la segunda propuesta de vacuna contra la COVID-19

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 Europea del Medicamento someterá a un proceso de revisión continua la propuesta desarrollada por BioNTech en colaboración con Pfizer [...]

2020-10-09T20:41:53+00:0009.10.2020|Drug Development Strategy, Regulatory Affairs|

EMA: New online platform for scientific advice

From 19 October 2020, developers of human or veterinary medicines should use EMA’s IRIS Regulatory & Scientific Information Management Platform to request scientific advice. At any stage of a medicine's development, the developer can ask for guidance and direction from EMA, known as scientific advice, on the best methods and study designs to generate robust data on how well [...]

2020-10-09T20:37:13+00:0009.10.2020|Drug Development Strategy, Regulatory Affairs|

EMA starts second rolling review of a COVID-19 vaccine

EMA’s human medicines committee (CHMP) has started a ‘rolling review’ of data on a vaccine for COVID-19 known as BNT162b2, which is being developed by BioNTech in collaboration with Pfizer. The start of the rolling review means that the committee has started evaluating the first batch of data on the vaccine, which come from laboratory studies (non-clinical [...]

2020-10-08T19:18:58+00:0008.10.2020|Drug Development Strategy, Regulatory Affairs|

Infarmed: Reguladores do medicamento da UE defendem transparência e independência para os tratamentos e vacinas COVID-19

A Agência Europeia de Medicamentos (EMA na sigla em inglês), reafirmou hoje que manterá o seu compromisso de longa data, relativamente à independência e transparência na avaliação dos tratamentos e vacinas para a COVID-19. Comunicado de Imprensa - Reguladores do medicamento da UE defendem transparência e independência para os tratamentos e vacinas COVID-19  Posted on [...]

2020-10-08T19:13:31+00:0008.10.2020|Regulatory Affairs|

EMA: EU regulators fully uphold transparency and independence standards for COVID-19 treatments and vaccines

The European Medicines Agency (EMA) has re-affirmed today that it will uphold its long-standing commitment to independence and transparency in its evaluation of COVID-19 treatments and vaccines. In an open letter  sent to European Ombudsman Emily O’Reilly in response to an enquiry on the role of EMA and its pandemic task force during the COVID-19 crisis, the Agency explains [...]

2020-10-07T20:57:17+00:0007.10.2020|Regulatory Affairs|

FDA Approves Drug Combination for Treating Mesothelioma

Today, the U.S. Food and Drug Administration approved Opdivo (nivolumab) in combination with Yervoy (ipilimumab) for the first-line treatment of adults with malignant pleural mesothelioma that cannot be removed by surgery. This is the first drug regimen approved for mesothelioma in 16 years and the second FDA-approved systemic therapy for mesothelioma. “Today’s approval of nivolumab [...]

2020-10-07T20:26:18+00:0007.10.2020|Drug Development Strategy, Regulatory Affairs|

EMA: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 28 September – 1 October 2020

PRAC reviews a signal with Veklury EMA’s safety committee (PRAC) has started a review of a safety signal to assess reports of acute  kidney injury in some patients with COVID-19 taking Veklury (remdesivir). Veklury has been given a ‘conditional marketing authorisation’ in the EU for the treatment of COVID-19 in adults and adolescents from 12 years of age [...]

2020-10-05T20:51:42+00:0005.10.2020|Pharmacovigilance, Regulatory Affairs|

EMA reminds physicians to use Tecentriq with nab-paclitaxel for treating breast cancer

EMA is reminding physicians to use Tecentriq (atezolizumab) only in combination with nab-paclitaxel and not with conventional paclitaxel when treating patients with locally advanced or metastatic triple-negative breast cancer that cannot be surgically removed. EMA’s advice follows the release of results from a study, IMpassion131, which did not show that combining Tecentriq with conventional paclitaxel [...]

2020-10-05T20:46:57+00:0005.10.2020|Drug Development Strategy, Regulatory Affairs|

EMA starts first rolling review of a COVID-19 vaccine in the EU

EMA’s human medicines committee (CHMP) has started the first ‘rolling review’ of a COVID-19 vaccine, which is being developed by the company AstraZeneca in collaboration with the University of Oxford. The start of the rolling review means that the committee has started evaluating the first batch of data on the vaccine, which come from laboratory studies [...]

2020-10-05T20:39:14+00:0005.10.2020|Drug Development Strategy, Regulatory Affairs|

Infarmed: EMA recomenda a utilização de dexametasona nos doentes com COVID-19 que requerem terapia com oxigénio

O INFARMED, I.P. informa que o Comité de Medicamentos para Uso Humano (CHMP) da Agência Europeia de Medicamentos (EMA na sigla em inglês) concluiu recentemente a revisão dos resultados do estudo RECOVERY, que envolveu especificamente o uso do medicamento dexametasona, no tratamento de doentes com COVID-19 internados e no hospital, e emitiu um parecer favorável a 18/09/2020 [...]

2020-10-02T19:06:34+00:0002.10.2020|Regulatory Affairs|

FDA Approves First Drug to Treat Group of Rare Blood Disorders in Nearly 14 Years

Today, the U.S. Food and Drug Administration approved Nucala (mepolizumab) for adults and children aged 12 years and older with hypereosinophilic syndrome (HES) for six months or longer without another identifiable non-blood related cause of the disease. The new indication for Nucala is the first approval for HES patients in nearly 14 years. “Today’s approval [...]

2020-10-02T15:54:04+00:0002.10.2020|Drug Development Strategy, Regulatory Affairs|