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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|

FDA updates on surveillance inspections during COVID-19 – Coronavirus (COVID-19) Update

During COVID-19, the U.S. Food and Drug Administration will continue to utilize and implement additional alternative inspection tools and approaches while postponing domestic and foreign routine surveillance inspections. This will continue as local, national and international conditions warrant, with the exception of certain mission critical inspections. Mission critical inspections are identified on a case-by-case basis [...]

2020-05-18T20:21:04+00:0018.05.2020|Quality System and Audit, Regulatory Affairs|

FDA Authorizes First Diagnostic Test Using At-Home Collection of Saliva Specimens – Coronavirus (COVID-19) Update

Today, the U.S. Food and Drug Administration authorized the first diagnostic test with the option of using home-collected saliva samples for COVID-19 testing. Specifically, the FDA issued an emergency use authorization (EUA) to Rutgers Clinical Genomics Laboratory for their COVID-19 laboratory developed test (LDT), which had been previously added to the high complexity molecular-based LDT “umbrella” EUA, [...]

UK MHRA regulatory flexibilities resulting from coronavirus (COVID-19)

Guidance for industry on flexible approaches to regulation we are taking during the COVID-19 outbreak. We are working closely with the Department of Health and Social Care (DHSC) and other healthcare partners and stakeholders to rapidly develop a package of ‘flexibilities’ to regulatory guidance, in order to support the medicines supply chain and wider healthcare [...]

2020-04-06T11:12:55+00:0006.04.2020|Quality System and Audit, 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 y la Red EAMI apuestan por el fortalecimiento de los procesos de evaluación de medicamentos biosimilares en Iberoamérica

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 ha organizado, a través de la Red EAMI, el curso online “Capacitación técnica de medicamentos biosimilares”, con el fin [...]

2020-03-12T20:23:25+00:0012.03.2020|Quality System and Audit, Regulatory Affairs|

FDA Foreign Inspections: Coronavirus Disease 2019 (COVID-19) Update

Today, we are providing an update on the status of U.S. Food and Drug Administration inspections outside of the U.S. in response to the COVID-19 outbreak. After careful consideration, the FDA is postponing most foreign inspections through April, effective immediately. Inspections outside the U.S. deemed mission-critical will still be considered on a case-by-case basis. The [...]

2020-03-12T20:14:26+00:0012.03.2020|Quality System and Audit, Regulatory Affairs|

FDA steps to ensure quality of foreign products – Coronavirus Update

Recently, we provided an update on FDA-wide activities we are engaged in related to the novel coronavirus outbreak:  COVID-19. We continue to take a multi-pronged approach to this public health emergency, including focusing on actively facilitating efforts to diagnose, treat and prevent the disease; surveilling the medical product supply chain for potential shortages or disruptions [...]

2020-02-26T21:48:42+00:0026.02.2020|Quality System and Audit, Regulatory Affairs|

Infarmed: Orientações europeias dirigidas a fabricantes de dispositivos médicos da classe I

No passado dia 18 de dezembro de 2019 foi publicado, pela Comissão Europeia, o documento "MDCG 2019-15 Guidance notes for manufacturers of Class I medical device" relativo às orientações dirigidas a fabricantes para a colocação no mercado de dispositivos médicos de classe I. Esta publicação resultou da revisão e atualização das anteriores orientações já existentes, à luz do [...]

2020-01-12T12:39:01+00:0012.01.2020|Quality System and Audit, Regulatory Affairs|

FDA takes efforts to improve quality of compounded drugs from outsourcing facilities through collaboration and education as part of new Center of Excellence

Compounded drugs can serve an important role in meeting patients’ medical needs that cannot be met by an FDA-approved drug. Outsourcing facilities, a significant part of the industry producing compounded drugs used by hospitals, clinics, providers, and other health care systems, have rapidly evolved since the passage of the Drug Quality and Security Act (DQSA) in [...]

2019-12-28T12:18:46+00:0028.12.2019|Quality System and Audit, Regulatory Affairs|

EMA: Launch of international pilot programme on inspection of manufacturers of sterile medicines

EMA and its European and international partners are launching a pilot programme to increase their cooperation in the inspection of manufacturers of sterile medicines for human use. This new initiative is built on the success of and experience gained from a similar collaboration, the international active pharmaceutical ingredients (APIs) inspection programme. This collaboration will allow EMA, EU [...]

2019-12-23T17:19:01+00:0023.12.2019|Quality System and Audit, Regulatory Affairs|