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ANSM: Maladie de Parkinson: remise à disposition et évolution de Sinemet LP 200 mg/50 mg

Le médicament antiparkinsonien Sinemet LP 200 mg/50 mg, comprimé à libération prolongée sera à nouveau disponible à partir du mois d’avril 2021 alors qu’il était indisponible depuis mi-avril 2019. Cette remise à disposition est associée à un changement d’usine de fabrication qui est de nouveau localisée en Italie, alors qu’elle se trouvait aux Etats-Unis depuis [...]

2021-04-16T20:18:27+00:0016.04.2021|Regulatory Affairs|

FDA Issues Emergency Use Authorization for the Symbiotica COVID-19 Self-Collected Antibody Test System

The U.S. Food and Drug Administration today announced it has issued an emergency use authorization (EUA) for the Symbiotica COVID-19 Self-Collected Antibody Test System, the first antibody test authorized for use with home collected dried blood spot samples. Samples collected at home are then sent to a Symbiotica, Inc. laboratory for analysis. “The authorization of the first [...]

2021-04-14T21:18:56+00:0014.04.2021|Drug Development Strategy, Regulatory Affairs|

L’ANSM publie sa décision sur la demande de RTU pour l’ivermectine dans la prise en charge de la maladie COVID-19

Nous avons reçu une demande de recommandation temporaire d’utilisation (RTU) de l’ivermectine pour la prise en charge de la maladie Covid-19, de la part d’un avocat représentant une association et des professionnels de santé. Pour rappel, l’ivermectine par voie orale a une autorisation de mise sur le marché (AMM) en France et à l’étranger dans [...]

2021-04-12T21:38:57+00:0012.04.2021|Regulatory Affairs|

Pharmacovigilance Specialist based in Barcelona

Job Title Pharmacovigilance Specialist Job Summary Under the supervision of the Head of Pharmacovigilance, the position is responsible for supporting the Viglya activities in the following activities and roles. Primary Duties and Responsibilities Deputy EU QPPV for assigned projects. Local (deputy) QPPV for assigned projects - Spain. Project Lead for assigned projects. Maintain Safety Management [...]

Infarmed: Nota Informativa – Ponto de situação sobre os autotestes COVID-19

Com vista à autorização de autotestes COVID-19 pelo INFARMED, I.P., ao abrigo da Portaria n.º 56/2021, foram definidos os critérios de inclusão no regime excecional para a utilização de testes rápidos de antigénio de uso profissional por leigos. Neste âmbito, desde o dia 22 de março, o Infarmed tem recebido diversos pedidos, em relação aos [...]

2021-04-08T21:53:19+00:0008.04.2021|Regulatory Affairs|

FDA Makes Two Revisions to Moderna COVID-19 Vaccine Emergency Use Authorization to Help Increase the Number of Vaccine Doses Available

Today, the U.S. Food and Drug Administration announced two revisions regarding the number of doses per vial available for the Moderna COVID-19 Vaccine. The first revision clarifies the number of doses per vial for the vials that are currently available, in that the maximum number of extractable doses is 11, with a range of 10-11 [...]

2021-04-07T20:58:00+00:0007.04.2021|Regulatory Affairs|

FDA Continues to Advance Over-the Counter and Other Screening Test Development

Following recent U.S. Food and Drug Administration actions to support test development, the FDA took swift action this week to get more tests for screening asymptomatic individuals on the market. Today, the agency authorized several tests for over-the-counter (OTC) use without a prescription when used for serial screening. In addition to the tests authorized for [...]

2021-04-07T20:51:41+00:0007.04.2021|Drug Development Strategy, Regulatory Affairs|

EMA: EU recommendations for 2021-2022 seasonal flu vaccine composition

EMA has issued the recommendations for the influenza virus strains that vaccine manufacturers should include in vaccines for the prevention of seasonal influenza from autumn 2021. Manufacturers of egg-based or live attenuated trivalent vaccines for the 2021/2022 season should include these three virus strains: an A/Victoria/2570/2019 (H1N1)pdm09-like virus; an A/Cambodia/e0826360/2020 (H3N2)-like virus; a B/Washington/02/2019 (B/Victoria lineage)-like virus [...]

2021-04-06T22:22:50+00:0006.04.2021|Drug Development Strategy, Regulatory Affairs|

Infarmed: Disponibilidade de medicamentos: novas orientações e ferramentas de pesquisa

No âmbito da disponibilidade do medicamento, foram desenvolvidas as seguintes ações:   1) Melhoria no acesso à informação de ruturas e cessações de comercialização A partir de dia 30/03/2021, é possível verificar se determinado medicamento está em rutura ou deixou de ser comercializado através das pesquisas disponíveis na área da disponibilidade de medicamentos. Nesta área é possível aceder [...]

2021-04-06T20:41:41+00:0006.04.2021|Regulatory Affairs|

Pharmacovigilance Specialist based in Barcelona

Job Title Pharmacovigilance Specialist Job Summary Under the supervision of the Head of Pharmacovigilance, the position is responsible for supporting the Viglya activities in the following activities and roles. Primary Duties and Responsibilities Deputy EU QPPV for assigned projects. Local (deputy) QPPV for assigned projects - Spain. Project Lead for assigned projects. Maintain Safety Management [...]

FDA Approves First Cell-Based Gene Therapy for Adult Patients with Multiple Myeloma

The U.S. Food and Drug Administration approved Abecma (idecabtagene vicleucel), a cell-based gene therapy to treat adult patients with multiple myeloma who have not responded to, or whose disease has returned after, at least four prior lines (different types) of therapy. Abecma is the first cell-based gene therapy approved by the FDA for the treatment [...]

2021-03-31T10:02:04+00:0031.03.2021|Drug Development Strategy, Regulatory Affairs|

Pharmacovigilance Specialist based in Barcelona

Job Title Pharmacovigilance Specialist Job Summary Under the supervision of the Head of Pharmacovigilance, the position is responsible for supporting the Viglya activities in the following activities and roles. Primary Duties and Responsibilities Deputy EU QPPV for assigned projects. Local (deputy) QPPV for assigned projects - Spain. Project Lead for assigned projects. Maintain Safety Management [...]

FDA Authorizes Marketing of Device to Improve Gait in Multiple Sclerosis Patients

Today, the U.S. Food and Drug Administration authorized marketing of a new device indicated for use as a short-term treatment of gait deficit due to mild to moderate symptoms from multiple sclerosis (MS). The device is intended to be used by prescription only as an adjunct to a supervised therapeutic exercise program in patients 22 [...]

2021-03-31T09:53:21+00:0031.03.2021|Drug Development Strategy, Regulatory Affairs|

FDA Approves First in the World Device to Treat Patients with Congenital Heart Disease

Today, the U.S. Food and Drug Administration approved the first in the world non-surgical heart valve to treat pediatric and adult patients with a native or surgically-repaired right ventricular outflow tract (RVOT), the part of the heart that carries blood out of the right ventricle to the lungs. The device is designed for patients who [...]

2021-03-31T09:45:00+00:0031.03.2021|Drug Development Strategy, Regulatory Affairs|

EMA: Increase in vaccine manufacturing capacity and supply for COVID-19 vaccines from AstraZeneca, BioNTech/Pfizer and Moderna

EMA’s human medicines committee (CHMP) has adopted several important recommendations that will increase manufacturing capacity and supply of COVID-19 vaccines in the EU. New manufacturing site for AstraZeneca’s COVID-19 vaccine A new manufacturing site has been approved for the production of AstraZeneca’s COVID-19 vaccine active substance. The Halix site is located in Leiden, the Netherlands, and will bring [...]

2021-03-31T09:40:40+00:0031.03.2021|Quality System and Audit, Regulatory Affairs|

EMA issues advice on use of regdanvimab for treating COVID-19

EMA’s human medicines committee (CHMP) has completed its review on the use of the monoclonal antibody regdanvimab (also known as CT-P59) to treat patients with COVID-19. This review was undertaken to provide a harmonised scientific opinion at EU level to support national decision-making on the possible use of the antibody prior to marketing authorisation. The Agency concluded that [...]

2021-03-31T09:32:05+00:0031.03.2021|Drug Development Strategy, Regulatory Affairs|

EMA: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 22-25 March 2021

Five new medicines recommended for approval EMA’s human medicines committee (CHMP) recommended five medicines for approval at its March 2021 meeting. The Committee recommended granting a marketing authorisation for Copiktra (duvelisib) for the treatment of adults with relapsed or refractory chronic lymphocytic leukaemia (CLL) or refractory follicular lymphoma (FL). The CHMP adopted a positive opinion for Ponvory (ponesimod) for the treatment of active [...]

2021-03-29T20:48:13+00:0029.03.2021|Drug Development Strategy, Regulatory Affairs|

UK MHRA pilots patient involvement in new applications

A pilot project that puts patient involvement at the heart of clinical trials and medicine development has been launched by the Medicines and Healthcare products Regulatory Agency (MHRA). From today, when new applications for selected medicines (new active substances and new indications) are received, the applicant company will be asked for evidence on the patient [...]

2021-03-28T11:22:21+00:0028.03.2021|Drug Development Strategy, Regulatory Affairs|

Pharmacovigilance Specialist based in Barcelona

Job Title Pharmacovigilance Specialist Job Summary Under the supervision of the Head of Pharmacovigilance, the position is responsible for supporting the Viglya activities in the following activities and roles. Primary Duties and Responsibilities Deputy EU QPPV for assigned projects. Local (deputy) QPPV for assigned projects – Spain. Project Lead for assigned projects. Maintain Safety Management [...]