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

EMA: Human medicines: highlights of 2020

EMA has published an overview of its key recommendations in 2020 on the authorisation and safety monitoring of medicines for human use. In 2020, EMA recommended 97 medicines for marketing authorisation. Of these, 39 had a new active substance which had never been authorised in the European Union before. The Agency recommended one vaccine and one treatment for COVID-19, and [...]

FDA Approves First Extended-Release, Injectable Drug Regimen for Adults Living with HIV

The U.S. Food and Drug Administration today approved Cabenuva (cabotegravir and rilpivirine, injectable formulation) as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults to replace a current antiretroviral regimen in those who are virologically suppressed on a stable antiretroviral regimen with no history of treatment failure and [...]

2021-01-24T19:53:33+00:0024.01.2021|Drug Development Strategy, Regulatory Affairs|

EMA: Global regulators highlight key role of healthcare professionals in fostering confidence in COVID-19 vaccines

EMA has endorsed a joint statement published today by the International Coalition of Medicines Regulatory Authorities (ICMRA) to inform and help healthcare professionals answer questions about the evaluation, approval and monitoring of safe, effective and high-quality COVID-19 vaccines. ‘Healthcare professionals are the heroes of this pandemic,’ said Emer Cooke, Chair of ICMRA and EMA’s Executive Director. ‘We [...]

Infarmed: Disponibilidade de Imunoglobulina Humana Normal

A 19 de outubro de 2020, o INFARMED, I.P. divulgou a circular informativa n.º 162/CD/2020, a qual divulgava orientações da Comissão Nacional de Farmácia e Terapêutica (CNFT) e advertia as instituições hospitalares e profissionais de saúde para uma utilização criteriosa da Imunoglobulina Humana Normal. A mesma circular alertava também para os efeitos da pandemia na [...]

2021-01-22T18:45:46+00:0022.01.2021|Regulatory Affairs|

ANSM: Point de situation sur la surveillance des vaccins contre la COVID-19

Un dispositif de surveillance renforcée et en temps réel a été mis en place en France par l'ANSM et le réseau des 31 Centres Régionaux de Pharmacovigilance (CRPV) pour identifier les effets indésirables qui pourraient survenir après la vaccination à partir des déclarations réalisées par les professionnels de santé ou par les personnes vaccinées. Depuis [...]

2021-01-22T18:33:07+00:0022.01.2021|Pharmacovigilance|

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 1.º trimestre de 2021, foi atualizada. Consulte a área Sistema de Preços de Referência, na página Comparticipação, nomeadamente a Circular Informativa N.º 03/CD/100.20.200, de 13/01/2021 e a Deliberação N.º 04/CD/2021. Posted on the Infarmed website on 18 [...]

2021-01-19T20:39:53+00:0019.01.2021|Regulatory Affairs|

(Cas) AEMPS: Actualización de la situación de los medicamentos de uso humano y veterinario a consecuencia del brexit

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. Tras el abandono de Reino Unido de la UE, el período de transición también se ha dado por finalizado a 31 [...]

EMA: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 11-14 January 2021

First monthly summary safety report for COVID-19 vaccine Comirnaty Starting this month, EMA’s safety committee (PRAC) will evaluate summary safety reports submitted monthly by marketing authorisations holders of COVID-19 vaccines. The first such report will be for Comirnaty. The company is expected to submit their monthly summary safety report in mid-January. The PRAC will evaluate and discuss it during [...]

2021-01-18T21:37:35+00:0018.01.2021|Pharmacovigilance|

ANSM: Point de situation sur la surveillance des vaccins contre la COVID-19

Le deuxième comité de suivi dédié à la surveillance des effets indésirables rapportés avec les vaccins COVID-19 s’est tenu le 14 janvier 2021 avec le réseau des Centres Régionaux de Pharmacovigilance (CRPV). Six effets indésirables graves avec une évolution favorable ont été observés en France avec le vaccin Comirnaty de Pfizer/BioNTech lors de cette troisième [...]

2021-01-18T21:32:40+00:0018.01.2021|Pharmacovigilance|

(Cas) AEMPS: La EMA recibe la solicitud de autorización condicional de la vacuna frente la COVID-19 de AstraZeneca

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 evaluación de los datos ya comenzó el pasado 1 de octubre a través del llamado rolling review, un mecanismo excepcional por el [...]

2021-01-16T13:58:46+00:0016.01.2021|Drug Development Strategy, Regulatory Affairs|

Infarmed: Horizon Scanning – Nova plataforma de submissão de informação

Dando continuidade ao projeto de Horizon Scanning iniciado em 2018, é com satisfação que o Infarmed comunica o lançamento de uma plataforma para recolha desta informação. Este projeto permitiu agregar informação relativa à introdução de novas tecnologias no Serviço Nacional de Saúde, viabilizando um melhor planeamento das atividades do Infarmed nesta área e contribuindo para a eficiência [...]

2021-01-16T13:55:29+00:0016.01.2021|Drug Development Strategy, Regulatory Affairs|

ANSM: Acétate de nomégestrol (Lutényl et génériques) /acétate de chlormadinone (Lutéran et génériques), et risque de méningiome: recommandations d’utilisation et de suivi des patientes

Compte tenu du sur-risque démontré de méningiome  associé à la prise d’acétate de nomégestrol (Lutényl et génériques) et d’acétate de chlormadinone (Lutéran et génériques), nous publions des recommandations portant sur l’utilisation de ces traitements et sur le suivi des femmes concernées . Ces recommandations se basent sur les réflexions menées par le comité d’experts  composé de médecins et d’acteurs associatifs [...]

2021-01-16T13:46:08+00:0016.01.2021|Pharmacovigilance|

UK MHRA: New partnership pledges clear and consistent evidence-based guidance on medicines for pregnant and breastfeeding women

The Consortium brings together 16 leading organisations, spanning the NHS, regulators, and leading third sector and charitable organisations A major new initiative to ensure pregnant and breastfeeding women can make informed decisions about their healthcare was announced today by health minister, Nadine Dorries. The Safer Medicines in Pregnancy and Breastfeeding Consortium brings together 16 leading organisations [...]

2021-01-13T22:35:01+00:0013.01.2021|Pharmacovigilance|

(Cas) AEMPS: La EMA incluye la posibilidad de utilizar una dosis extra de los viales de la vacuna Comirnaty frente a 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. El CHMP de la EMA, formado por expertos de las autoridades competentes, entre ellos la AEMPS, ha actualizado la información de [...]

2021-01-12T20:07:48+00:0012.01.2021|Pharmacovigilance|

ANSM: Point de situation sur la surveillance des vaccins contre la COVID-19

Le premier comité de suivi dédié à la surveillance des effets indésirables rapportés avec les vaccins COVID-19 s’est tenu le 7 janvier 2021 avec le réseau des Centres Régionaux de Pharmacovigilance (CRPV). Pour cette deuxième semaine de vaccination, les CRPV ont poursuivi les contacts réguliers avec les établissements ayant débuté les vaccinations avec le vaccin [...]

2021-01-12T20:00:05+00:0012.01.2021|Pharmacovigilance|

EMA receives application for conditional marketing authorisation of COVID-19 Vaccine AstraZeneca

EMA has received an application for conditional marketing authorisation (CMA) for a COVID-19 vaccine developed by AstraZeneca and Oxford University. The assessment of the vaccine, known as COVID-19 Vaccine AstraZeneca, will proceed under an accelerated timeline. An opinion on the marketing authorisation could be issued by 29 January during the meeting of EMA’s scientific committee for human medicines (CHMP), provided [...]

2021-01-12T19:48:04+00:0012.01.2021|Drug Development Strategy, Regulatory Affairs|

UK MHRA: Moderna vaccine becomes third COVID-19 vaccine approved by UK regulator

The vaccine has been approved after meeting the required safety, quality and effectiveness standards. The COVID-19 vaccine developed by Moderna has today been given regulatory approval for supply by the Medicines and Healthcare products Regulatory Agency (MHRA). This follows a thorough and rigorous assessment by the MHRA’s teams of scientists, including advice from the independent Commission on [...]

2021-01-10T11:01:04+00:0010.01.2021|Drug Development Strategy, Regulatory Affairs|

EMA: Extra dose from vials of Comirnaty COVID-19 vaccine

EMA’s human medicines committee (CHMP) has recommended updating the product information for Comirnaty to clarify that each vial contains 6 doses of the vaccine. In order to extract six doses from a single vial, low dead-volume syringes and/or needles should be used. The low dead-volume syringe and needle combination should have a dead volume of no more [...]

2021-01-10T10:56:53+00:0010.01.2021|Pharmacovigilance|