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Infarmed: Normas para logística, distribuição e utilização das vacinas contra a COVID-19

Tendo sido autorizada a introdução no mercado europeu da vacina Comirnaty, a 21 de dezembro de 2020, e podendo dar-se início à campanha de vacinação após a sua receção em território nacional, torna-se premente a divulgação das normas a serem aplicadas à logística, distribuição e utilização das referidas vacinas. As vacinas são recebidas em Portugal num [...]

2020-12-30T11:12:12+00:0030.12.2020|Quality System and Audit, Regulatory Affairs|

UK MHRA: Independent batch release testing of COVID-19 (coronavirus) vaccines by the NIBSC

The National Institute for Biological Standards and Control will carry out independent testing in the UK for any potential COVID-19 vaccines. As is the case for current, licensed vaccines, the quality of each batch of any potential COVID-19 vaccine will be evaluated by an independent laboratory. The independent laboratory will also carry out a thorough [...]

2020-12-29T10:37:53+00:0029.12.2020|Quality System and Audit, Regulatory Affairs|

FDA Holds Advisory Committee Meeting to Discuss Authorization of COVID-19 Vaccine Candidate as Part of Agency’s Review of Safety and Effectiveness Data

The following is attributed to FDA Commissioner Stephen M. Hahn, M.D. For nearly 11 months, we have all been learning to live and function in a state of uncertainty, adjusting to a “new normal” as the COVID-19 pandemic has drastically affected the way most of us live, and has also tragically claimed the lives of [...]

Infarmed: EMA publica orientações sobre flexibilização quanto à informação do medicamento (Folheto Informativo e Rotulagem) para as vacinas contra a COVID-19

No âmbito das medidas de flexibilidade quanto à rotulagem e embalagem das vacinas contra a COVID-19, o Infarmed informa que a Agência Europeia de Medicamentos (EMA na sigla em inglês) publicou o documento Questions and answers on labelling flexibilities for COVID19 vaccines , com orientações sobre a forma como poderá ser agilizado o desenvolvimento das vacinas no [...]

2020-12-09T20:39:51+00:0009.12.2020|Quality System and Audit, Regulatory Affairs|

FDA, Homeland Security Agencies Take Additional Action to Prevent Import of Illegal and Harmful Medical Products Through International Mail Facilities

Recently, leadership from the U.S. Food and Drug Administration, the U.S. Customs and Border Protection (CBP), and the U.S. Immigration and Customs Enforcement, Homeland Security Investigations (ICE-HSI) signed a Memorandum of Understanding (MOU) to stop harmful products that pose a threat to public health and attempt to enter the U.S. through International Mail Facilities (IMFs). [...]

2020-11-04T21:07:01+00:0004.11.2020|Quality System and Audit, Regulatory Affairs|

Infarmed: Novo Sistema de Informação para Dispositivos Médicos (SIDM)

Com o objetivo de garantir que os dispositivos médicos (DM) existentes no mercado nacional respeitam os requisitos regulamentares de qualidade, segurança e desempenho, assegurando assim os mais elevados níveis de segurança e proteção da Saúde Pública, o sistema de informação existente foi revisto de forma a otimizar a gestão de informação relacionada com DM, agilizando [...]

2020-10-24T16:21:35+00:0024.10.2020|Quality System and Audit, Regulatory Affairs|

(Cas) La AEMPS actualiza la información para los Titulares de Autorizaciones de Comercialización de medicamentos de uso humano, autorizados por procedimiento nacional (incluyendo PRM/PDC) en relación con el art. 5(3) del Reglamento (CE) N° 726/2004

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. Con fecha 06 de agosto de 2020, la Agencia Europea de Medicamentos (en adelante, EMA) y el Grupo Europeo de Coordinación [...]

2020-09-25T13:23:15+00:0025.09.2020|Quality System and Audit, Regulatory Affairs|

FDA Provides Guidance to Industry for Detecting and Preventing Nitrosamines in Drugs

Since the outset of our discovery of impurities called nitrosamines in some types of drugs more than two years ago, the U.S. Food and Drug Administration has undertaken a thorough investigation in an effort to protect patients. While nitrosamines are common in water and foods, nitrosamine impurities may increase the risk of cancer if people [...]

2020-09-07T21:38:35+00:0007.09.2020|Quality System and Audit, Regulatory Affairs|

(Cas) AEMPS: Información a los laboratorios titulares de medicamentos de uso humano que contienen la sustancia activa ‘LEUPRORELINA’ de liberación prolongada

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 informa de la publicación del Dictamen del CMDh de fecha de 26 de junio, publicado en la página web [...]

2020-08-24T19:17:00+00:0024.08.2020|Quality System and Audit, Regulatory Affairs|

Infarmed: Suspensão da atividade do distribuidor por grosso Steinbock Apotheke OG (Áustria)

A autorização da atividade de distribuição por grosso de medicamentos da entidade Steinbock Apotheke OG foi suspensa após a deteção de não-conformidades com as boas práticas de distribuição, conforme divulgado pela autoridade competente austríaca. Face ao exposto, as entidades não devem comercializar medicamentos com o referido distribuidor, pelo que as entidades que tenham adquirido medicamentos [...]

2020-08-06T12:38:25+00:0006.08.2020|Quality System and Audit, Regulatory Affairs|

EMA: Panexcell Clinical Laboratories: suspension of medicines over flawed studies

EMA’s human medicines committee (CHMP) has recommended the suspension of the marketing authorisations of generic medicines tested by Panexcell Clinical Laboratories Priv. Ltd at its site in Mumbai, India. The recommendation comes after Austrian and German inspectors found irregularities in how the company carried out bioequivalence studies. These are studies used to show that a generic medicine produces the same amount of active substance in [...]

(Cas) AEMPS: Información a los Laboratorios Titulares de Medicamentos de Uso Humano que contienen ‘FLUOROURACILO y sustancias afines (CAPECITABINA, TEGAFUR Y FLUCITOSINA)’

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 de la Decisión de Ejecución de la Comisión C (2020) 4718 final, de fecha 7.7.2020, [...]

2020-07-29T20:49:31+00:0029.07.2020|Quality System and Audit, Regulatory Affairs|

(Cas) La AEMPS presenta su Memoria Anual de Actividades 2019

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 documento refleja, de una forma global, los procesos desempeñados en la AEMPS durante el año 2019. Al cierre de dicho [...]

Infarmed: EMA finaliza parecer sobre presença de nitrosaminas em medicamentos

O comité de medicamentos para uso humano (CHMP) da Agência Europeia de Medicamentos (EMA, na sigla inglesa) emitiu um parecer exigindo aos laboratórios da indústria farmacêutica que tomem medidas para limitar o máximo possível, a presença de nitrosaminas em medicamentos de uso humano e para garantir que os níveis dessas impurezas não excedam os limites [...]

2020-07-17T21:34:25+00:0017.07.2020|Pharmacovigilance, Quality System and Audit|

EMA finalises opinion on presence of nitrosamines in medicines

EMA’s human medicines committee (CHMP) has issued an opinion requiring companies to take measures to limit the presence of nitrosamines in human medicines as far as possible and to ensure levels of these impurities do not exceed set limits. The measures will ensure that nitrosamines are either not present or are present below levels identified [...]

2020-07-16T21:00:26+00:0016.07.2020|Pharmacovigilance, Quality System and Audit|

EMA: Global regulators work towards alignment on policy approaches and regulatory flexibility during COVID-19 – update #3

As part of its coordinated response to the pandemic, the International Coalition of Medicines Regulatory Authorities (ICMRA) convened its regular high-level meeting of regulators from around the world on 27 May 2020 to discuss COVID-19 policies, regulatory aspects of  COVID-19 medicine development and pragmatic approaches to address challenges posed by the ongoing pandemic. ICMRA has established a [...]

2020-06-07T12:27:52+00:0007.06.2020|Quality System and Audit, Regulatory Affairs|

(Cas) La AEMPS realizará inspecciones de Buena Práctica de Farmacovigilancia en remoto debido 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. Esta modalidad alternativa se hace necesaria para continuar con la actividad de inspección ante la situación sanitaria creada por la COVID [...]

2020-06-04T21:27:15+00:0004.06.2020|Pharmacovigilance, Quality System and Audit|

(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|

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|