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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|

EMA: Restrictions in use of cyproterone due to meningioma risk

On 13 February 2020, EMA’s safety committee (PRAC) recommended that medicines with daily doses of 10 mg or more of cyproterone should only be used for androgen-dependent conditions such as hirsutism (excessive hair growth), alopecia (hair loss), acne and seborrhoea (excessively oily skin) once other treatment options, including treatment with lower doses, have failed. Once higher [...]


EMA: No change is needed in use of direct oral anticoagulants following EMA-funded study

No change to the conditions of use of the direct oral anticoagulants Eliquis (apixaban), Pradaxa (dabigatran etexilate) and Xarelto (rivaroxaban) is needed following a review of the results of a European study of real-world data for these medicines. The study, commissioned by EMA and using real-world data from Denmark, France, Germany, Spain, the Netherlands and [...]


EMA: Recommendations to restrict use of fosfomycin antibiotics

EMA has recommended that fosfomycin medicines given by infusion (drip) into a vein should only be used to treat serious infections when other antibiotic treatments are not suitable. Fosfomycin medicines given by mouth can continue to be used to treat uncomplicated bladder infections in women and adolescent girls. They can also be used to prevent [...]


EMA: Benefits of medicines containing combination of methocarbamol and paracetamol continue to outweigh risks

EMA has concluded that the benefits of medicines containing methocarbamol and paracetamol continue to outweigh their risks in the short-term treatment of painful muscle spasms. EMA’s review was started because recent publications1,2,had raised questions about the effectiveness of the combination of these substances at treating conditions such as low back pain in the doses at [...]


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|

(Cas) La AEMPS recuerda los riesgos de comprar medicamentos falsificados para el tratamiento del COVID-19 a través de webs ilegales

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. Únicamente deben comprarse medicamentos sin prescripción médica en oficinas de farmacia autorizadas, que estén registradas para la venta online. No existe [...]


L’ANSM sécurise l’accès aux traitements Plaquenil et Kaletra pour les patients atteints de maladie chronique

L’ANSM a été alertée de difficultés d’accès dans les pharmacies en ville aux traitements Plaquenil (hydroxychloroquine) et Kaletra et son générique (lopinavir/ritonavir) pour les malades chroniques à qui ces médicaments sont destinés (VIH, lupus, polyarthrite rhumatoïde…). A ce jour ni le Plaquenil ni le Kaletra n’ont d’indication dans la prise en charge du COVID-19 en [...]

2020-03-27T16:25:38+00:0027.03.2020|Sin categoría|

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|