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EMA Guidance on the Management of Clinical Trials during the COVID-19 (Coronavirus) pandemic

The European Medicines Agency (EMA), Good Clinical Practice (GCP) Inspectors Working Group, the Clinical Trials Facilitation and Coordination Group (CTFG, a working group of the Heads of Medicines Agency (HMA)), the Clinical Trials Expert Group (CTEG, a working group of the European Commission representing Ethics Committees and National Competent Authorities) and the European Commission (EC) [...]

2020-03-31T22:37:57+00:0031.03.2020|Regulatory Affairs, Training|

(Cas) AEMPS: Recomendaciones de la AEMPS para la gestión de medicamentos de uso habitual en las unidades de cuidados intensivos

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 incremento de la demanda de los medicamentos utilizados en unidades de cuidados intensivos está provocando tensiones puntuales en el suministro [...]

2020-03-31T22:31:44+00:0031.03.2020|Regulatory Affairs|

Infarmed: Informação aos distribuidores por grosso e fabricantes de medicamentos de uso humano (COVID-19)

Foi publicada na área COVID-19, no separador "Entidades", informação para os distribuidores por grosso e fabricantes de medicamentos de uso humano (Norma 006/2020, de 26/03/2020). Pelo papel fulcral que representam no circuito do medicamento, os distribuidores por grosso e os fabricantes demedicamentos devem adotar uma serie de medidas que visem proteger os seus colaboradores, contribuindo para impedir a [...]

2020-03-31T21:14:26+00:0031.03.2020|Regulatory Affairs|

EMA: No change to product information for breast cancer medicine Tyverb following re-assessment of data

The product information for Tyverb, a breast cancer medicine, will continue to state that no data are available on the effectiveness of Tyverb used together with an aromatase inhibitor compared with trastuzumab used with an aromatase inhibitor in patients previously treated with trastuzumab. In July 2018, results of a study involving women with ‘HR+/HER2+’ breast cancer and [...]

2020-03-31T21:07:09+00:0031.03.2020|Pharmacovigilance, Regulatory Affairs|

EMA: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 23-26 March 2020

Eight new medicines recommended for approval EMA’s human medicines committee (CHMP) recommended eight medicines for approval at its March 2020 meeting. In line with EMA’s measures to limit the spread of COVID-19, the meeting was held virtually. The Committee recommended granting a conditional marketing authorisation for Zolgensma* (onasemnogene abeparvovec), an advanced therapy medicinal product (ATMP) for the treatment of babies and young children [...]

EMA: New gene therapy to treat spinal muscular atrophy

EMA has recommended granting a conditional marketing authorisation in the European Union for the gene therapy Zolgensma (onasemnogene abeparvovec) to treat babies and young children with spinal muscular atrophy (SMA), a rare and often fatal genetic disease that causes muscle weakness and progressive loss of movement. There are currently limited treatment options for children with SMA in [...]

2020-03-30T19:52:06+00:0030.03.2020|Drug Development Strategy, Regulatory Affairs|

Infarmed: Medidas excecionais no âmbito da realização de Ensaios Clínicos durante o período de risco para a saúde pública (COVID-19)

Na sequência de emergência de Saúde Pública de âmbito Internacional, declarada pela Organização Mundial de Saúde em 30/01/2020 para a infeção por SARS-CoV-2 (novo coronavírus 2019), e no que se refere à realização de ensaios clínicos em Portugal, o INFARMED, I.P. admite que promotores, centros de ensaio clínico e equipas de investigação considerem necessária a [...]

2020-03-29T20:40:25+00:0029.03.2020|Regulatory Affairs|

(Cas) La AEMPS prorroga el plazo para que los TACs presenten el análisis de riesgo de formación de nitrosaminas debido a la situación sanitaria actual

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 nueva fecha límite para completa la primera fase (STEP 1) del análisis del riesgo de formación y presencia de impurezas [...]

2020-03-27T20:22:30+00:0027.03.2020|Quality System and Audit, Regulatory Affairs|

FDA Continues to Support Transparency and Collaboration in Drug Approval Process as the Clinical Data Summary Pilot Concludes

As our society becomes more global, it has become increasingly clear that the U.S. Food and Drug Administration needs to take a more collaborative approach to our drug approval process. Today, drugs that are approved by the FDA to be marketed in the United States are developed both in and out of the United States. [...]

2020-03-27T16:18:01+00:0027.03.2020|Drug Development Strategy, Regulatory Affairs|

UK MHRA: Chloroquine and Hydroxychloroquine not licensed for coronavirus (COVID-19) treatment

Recent media reports have suggested that chloroquine can protect patients from coronavirus or treat COVID-19, the illness caused by a coronavirus. We understand these are challenging times, and patients may be worried, but we are doing everything we can to continue to ensure patient safety. Chloroquine and hydroxychloroquine are not licensed to treat COVID-19 related [...]

2020-03-26T20:36:43+00:0026.03.2020|Drug Development Strategy, Regulatory Affairs|

EMA: Global regulators map out data requirements for phase 1 COVID-19 vaccine trials

Global regulators have published a report today presenting the outcomes of a workshop on COVID-19 vaccine development that was convened under the umbrella of the International Coalition of Medicines Regulatory Authorities (ICMRA). The meeting report provides an overview of regulatory considerations related to COVID-19 vaccine development and data required for regulatory decision-making on two key points: Pre-clinical [...]

2020-03-26T20:30:21+00:0026.03.2020|Drug Development Strategy, Regulatory Affairs|

EMA – COVID-19: Beware of falsified medicines from unregistered websites

EMA is urging the general public not to buy medicines from unauthorised websites and other vendors aiming to exploit fears and concerns during the ongoing pandemic of coronavirus disease (COVID-19). Vendors may claim that their products can treat or prevent COVID-19 or may appear to provide easy access to legitimate medicines that are otherwise not readily [...]

2020-03-26T20:24:35+00:0026.03.2020|Pharmacovigilance, Regulatory Affairs|

Infarmed: Atualização da lista de medicamentos abrangidos pela notificação prévia de exportação ou distribuição para outros Estados-membros

No âmbito das medidas de combate à pandemia por SARS-CoV-2 (novo coronavírus 2019), agente infeccioso causador da doença COVID-19, ao abrigo do disposto no Artigo 4.º do Decreto-Lei n.º 176/2006, de 30 de agosto, na sua atual redação, foi decidida a atualização da Lista de Notificação Prévia (LNP), prevista na alínea b) do n.º 2 [...]

2020-03-25T20:04:29+00:0025.03.2020|Regulatory Affairs|

Infarmed: Novo medicamento para doença renal crónica (Veltassa – Patirómero – Avaliação prévia hospitalar concluída)

O medicamento Veltassa (Patirómero) obteve autorização para ser utilizado em meio hospitalar na indicação: Tratamento da hipercaliemia em adultos com doença renal crónica estádios 3-4 sob terapêutica com inibidores do eixo renina-angiotensina-aldosterona. Concluiu-se que existe sugestão de valor terapêutico acrescentado não quantificável do patirómero em relação a cuidados padrão [que inclui dieta pobre em potássio, [...]

2020-03-25T19:54:27+00:0025.03.2020|Drug Development Strategy, Regulatory Affairs|

FDA Statement: Insulin Gains New Pathway to Increased Competition

Today is a historic day and a landmark moment for patients with diabetes and other serious medical conditions, as insulin and certain other biologic drugs transition to a different regulatory pathway. This regulatory transition, mandated by Congress and implemented by the FDA, is incredibly important for patients. For the first time, a pathway will be open [...]

2020-03-25T19:47:46+00:0025.03.2020|Drug Development Strategy, Regulatory Affairs|

FDA Guidance: Policy for Certain REMS Requirements During the COVID-19 Public Health Emergency Guidance for Industry and Health Care Professionals

FDA is issuing this guidance to communicate its temporary policy for certain risk evaluation and mitigation strategies (REMS) requirements for the duration of the public health emergency (PHE) declared by the Secretary of Health and Human Services (HHS) on January 31, 2020.   Posted on the FDA website on 22 March 2020

2020-03-25T17:39:05+00:0025.03.2020|Regulatory Affairs, Training|

FDA provides update on patient access to certain REMS drugs during COVID-19 public health emergency – Coronavirus (COVID-19) Update

Today, as part of the U.S. Food and Drug Administration’s ongoing efforts to address the coronavirus pandemic (COVID-19), the agency issued a new guidance to sponsors and healthcare providers regarding certain Risk Evaluation and Mitigation Strategy (REMS)-required testing during this time. “The FDA recognizes that during the COVID-19 public health emergency, the completion of some REMS-required laboratory [...]

2020-03-25T17:28:08+00:0025.03.2020|Drug Development Strategy, Regulatory Affairs|

UK MHRA guidance on Coronavirus (COVID-19)

The MHRA is working closely with DHSC and other healthcare partners on COVID-19. We are prioritising work including: Supporting and authorising the development of vaccines Clinical trials of new medicines Managing the supply of medicines and healthcare products We also provide information to patients, manufacturers and healthcare professionals through our established information channels and alert systems. The [...]

FDA Issues first Emergency Use Authorization for Point of Care Diagnostic – Coronavirus (COVID-19) Update

Today, the U.S. Food and Drug Administration issued the first emergency use authorization for a point-of-care COVID-19 diagnostic for the Cepheid Xpert Xpress SARS-CoV-2 test. “The test we’re authorizing today will be able to provide Americans with results within hours, rather than days like the existing tests, and the company plans to roll it out by March [...]

2020-03-24T18:20:06+00:0024.03.2020|Drug Development Strategy, Regulatory Affairs|

ANSM: Essais cliniques: procédures accélérées pour l’évaluation des traitements du COVID-19 et recommandations aux promoteurs sur les essais en cours

L’ANSM est mobilisée auprès des équipes de recherche afin que les essais cliniques en cours se poursuivent dans les meilleures conditions, tout en continuant d’assurer la sécurité des patients. En effet, la poursuite des essais cliniques dans les hôpitaux va être perturbée en raison de la mobilisation des équipes médicales et des risques potentiels liés [...]

2020-03-24T18:12:08+00:0024.03.2020|Drug Development Strategy, Regulatory Affairs|