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(Cas) AEMPS: Información a los Laboratorios Titulares de Medicamentos de uso Humano que contienen la sustancia activa ‘CIPROTERONA’

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. Este organismo informa de la publicación del Dictamen del CMDh de fecha de 27 de marzo de 2020 en la página [...]

2020-05-29T17:38:28+00:0029.05.2020|Regulatory Affairs|

(Cas) AEMPS: Ampliación del plazo de adecuación del etiquetado y las instrucciones de uso de productos sanitarios como 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. La AEMPS amplía el plazo hasta el 25 de mayo de 2021 para la adecuación del etiquetado y de las instrucciones [...]

2020-05-29T17:32:05+00:0029.05.2020|Regulatory Affairs|

(Cas) AEMPS: Orientaciones para los laboratorios del Programa Nacional de Cumplimiento de BPL ante la situación originada por 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 grupo de Buenas Prácticas de Laboratorio (BPL) del Comité Técnico de Inspección (CTI) informa a los laboratorios BPL de las [...]

2020-05-29T17:25:23+00:0029.05.2020|Quality System and Audit, Regulatory Affairs|

EMA: Global regulators commit to cooperate on observational research in the context of COVID-19

Regulators from around the world have agreed three priority areas for cooperation on observational research during COVID-19. They will collaborate on pregnancy research, on medicines used in clinical practice and on vaccine safety and effectiveness monitoring. High-quality observational research is an important complement to the evidence on the safety and effectiveness of vaccines and treatments for [...]

2020-05-28T20:48:23+00:0029.05.2020|Regulatory Affairs|

Infarmed: Novas medidas para evitar erros de administração de medicamentos contendo leuprorrelina

A Agência Europeia do Medicamento (EMA na sigla inglesa) e o Infarmed recomendam novas medidas para administração de medicamentos contendo leuprorrelina de libertação prolongada (formulação depot) para evitar erros de manuseamento que podem resultar em subdosagem e falta de eficácia. Os medicamentos contendo leuprorrelina (administrados por via subcutânea ou intramuscular de libertação contínua prolongada) são utilizados no [...]

2020-05-28T20:41:20+00:0028.05.2020|Sin categoría|

UK MHRA: Drug Safety Update (May 2020)

Coronavirus (COVID-19): new dedicated Yellow Card reporting site for medicines and medical devices Reporting to the new site will enable the MHRA to rapidly identify new and emerging side effects and medical device incidents in COVID-19 treatment, inclluding side effects for medicines taken by patients to manage long-term … Valproate Pregnancy Prevention Programme: temporary advice [...]


WHO Pharmaceuticals Newsletter (No.2, 2020)

This edition of the Newsletter also includes the recommendations from the 42nd Annual Meeting of Representatives of National Pharmacovigilance Centres participating in the WHO Programme for International Drug Monitoring. Given the current interest over the use of chloroquine and hydroxychloroquine in COVID-19, we have also included a summary of case safety reports in Vigibase for [...]

EMA: Global regulators work towards alignment on policy approaches and regulatory flexibility during COVID-19 – update #2

The International Coalition of Medicines Regulatory Authorities (ICMRA) convened a virtual meeting of regulators from around the world on 14 May 2020 to discuss high-level policy issues and regulatory requirements to respond to the ongoing COVID-19 pandemic. The strategic meeting underlined the need and commitment by global regulators to cooperate and align their approaches to clinical trial management, [...]

2020-05-28T20:05:54+00:0028.05.2020|Regulatory Affairs|

FDA Authorizes First Standalone At-Home Sample Collection Kit That Can Be Used With Certain Authorized Tests

The U.S. Food and Drug Administration has authorized an at-home sample collection kit that can then be sent to specified laboratories for COVID-19 diagnostic testing. Specifically, the FDA issued an emergency use authorization (EUA) to Everlywell, Inc. for the Everlywell COVID-19 Test Home Collection Kit. Everlywell’s kit is authorized to be used by individuals at home who [...]

2020-05-25T21:23:33+00:0025.05.2020|Drug Development Strategy, Regulatory Affairs|

FDA Approves First Drug for Fourth-Line Treatment of Advanced Gastrointestinal Stromal Tumors

Today, the U.S. Food and Drug Administration approved Qinlock (ripretinib) tablets as the first new drug specifically approved as a fourth-line treatment for advanced gastrointestinal stromal tumor (GIST), a type of tumor that originates in the gastrointestinal tract. Qinlock is indicated for adult patients who have received prior treatment with three or more kinase inhibitor [...]

2020-05-25T20:17:54+00:0025.05.2020|Drug Development Strategy, Regulatory Affairs|

EMA: EU actions to support availability of medicines during COVID-19 pandemic – update #6

The EU Executive Steering Group on Shortages of Medicines Caused by Major Events held a virtual meeting on 13 May 2020. Participation to the meeting of the steering group was extended to all the heads of the national competent authorities (NCAs) of the EU Member States to discuss the measures taken by EU authorities to ensure the continued availability [...]

2020-05-25T20:06:12+00:0025.05.2020|Regulatory Affairs|

EMA: International coordination needed to encourage conduct of large, decision-relevant COVID-19 clinical trials

Regulators are highlighting the need for a comprehensive international coordination mechanism to allow the conduct of adequately powered, randomised controlled trials, which can generate sound evidence on the effects of therapeutics or vaccines against COVID-19. This follows a call made by EMA’s Human Medicines Committee (CHMP) for the research community to pool resources into large, well-designed, multi-arm clinical [...]

2020-05-25T19:57:43+00:0025.05.2020|Drug Development Strategy, Regulatory Affairs|

EMA: Update of EU recommendations for 2020/2021 seasonal flu vaccine composition

EMA has issued an update of the EU recommendations for the influenza virus strains that vaccine manufacturers should include in vaccines for the prevention of seasonal influenza from autumn 2020. The recommendations now also contain a decision on a suitable H1N1 virus for seasonal live attenuated influenza vaccines. The list of reagents for vaccine standardisation has also [...]

2020-05-25T19:53:10+00:0025.05.2020|Drug Development Strategy, Regulatory Affairs|

EMA: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 11-14 May 2020

PRAC concludes review of new information on the known risk of breast cancer with hormone replacement therapy EMA’s safety committee (PRAC) recommends updating the current safety information for hormone replacement therapy (HRT) used to treat symptoms of the menopause. The updates are based on evidence from a large study published in The Lancet in August 2019, [...]


EMA: Leuprorelin depot medicines: PRAC recommends new measures to avoid handling errors

EMA’s safety committee (PRAC) is recommending measures to avoid handling errors in the preparation and administration of leuprorelin depot medicines. A review by the PRAC found that handling errors resulted in some patients receiving insufficient amounts of their medicine. The errors reported included incorrect use of the needle or syringe, causing the medicine to leak from the [...]


FDA: Federal judge enters temporary injunction against Xephyr LLC doing business as N-Ergetics, preventing sale of Colloidal Silver Products for COVID-19

A federal court has entered a temporary restraining order against Xephyr LLC, doing business as N-Ergetics, and three individuals associated with the entity, requiring them to immediately stop distributing colloidal silver products. The defendants offered these products for sale to treat coronavirus, which includes Coronavirus Disease 2019 (COVID-19) and many other diseases. In granting the [...]

2020-05-22T17:59:03+00:0022.05.2020|Pharmacovigilance, Regulatory Affairs|

FDA issues warning letters to two breast implant manufacturers as part of ongoing efforts to protect patients

Allergan cited for failure to comply with post-approval study requirements; Ideal Implant Inc. cited for failures relating to quality system and medical device reporting regulations Today, the U.S. Food and Drug Administration issued warning letters to two breast implant manufacturers for failure to comply with various regulatory requirements. The agency issued a warning letter to breast implant [...]

2020-05-22T17:53:08+00:0022.05.2020|Quality System and Audit, Regulatory Affairs|

ANSM: Traitement de l’artériopathie oblitérante des membres inférieurs (AOMI): l’utilisation de ballons ou de stents au paclitaxel doit toujours être réservée aux patients les plus sévères

A l’issue d’une réunion d’échange ayant réuni le 3 mars des représentants de patients, des professionnels de santé du domaine ainsi que les autorités de santé, l’ANSM maintient ses recommandations de mai 2019 d’utiliser préférentiellement les options thérapeutiques alternatives aux ballons et aux stents au paclitaxel pour traiter les patients atteints d’artériopathie oblitérante des membres [...]

2020-05-22T17:39:48+00:0022.05.2020|Sin categoría|