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(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|

FDA sends warning to companies for offering unapproved umbilical cord blood products that may put patients at risk

The U.S. Food and Drug Administration has warned Liveyon Labs Inc. (Liveyon Labs) and Liveyon LLC, of Yorba Linda, California, and their presidents and chief executive officers, Roya Panah and John W. Kosolcharoen, for processing and distributing unapproved products derived from umbilical cord blood. They have also been warned regarding significant deviations from current good tissue [...]

(Cas) AEMPS: Información a los laboratorios titulares de Medicamentos de Uso Humano que contienen la sustancia activa “metotrexato”. Decisión de la Comisión C(2019) 7680 final, de fecha 21.10.2019.(Nº EMA: EMEA/H/A-31/1463)

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 Agencia Española de Medicamentos y Productos Sanitarios (AEMPS) informa de la publicación en su página web de la Decisión de [...]

2019-12-02T22:46:57+00:0002.12.2019|Quality System and Audit, Regulatory Affairs|

ANSM: Médicaments dérivés du sang: remise en conformité réglementaire du LFB

L’ANSM lève l’injonction qu’elle avait prononcée en mai 2018 à l’encontre du groupe pharmaceutique LFB. Cela fait suite aux dernières inspections qui ont permis d’établir la conformité réglementaire du laboratoire. L’ANSM continuera de veiller à l’approvisionnement de ces médicaments d’intérêt thérapeutique majeur, au bénéfice des patients. Dans le cadre de ses missions, l’ANSM assure une [...]

2019-11-24T20:12:42+00:0024.11.2019|Quality System and Audit, Regulatory Affairs|

FDA Statement on new testing results, including low levels of impurities in ranitidine drugs

Americans deserve to have confidence in the quality of drugs the U.S. Food and Drug Administration regulates – from the prescription medicines they take to the over-the-counter (OTC) products they use in their daily lives. Helping assure the quality and safety of these products is one of our greatest responsibilities. Over the past several weeks, [...]

2019-11-08T17:37:19+00:0008.11.2019|Quality System and Audit, Regulatory Affairs|

Infarmed: Suspensão de autorizações de distribuição por grosso de medicamentos de uso humano

O Infarmed suspendeu a autorização para o exercício da atividade de distribuição por grosso de medicamentos de uso humano das seguintes entidades: Medivip - Distribuição De Produtos Farmacêuticos, Lda. (Autorização N.º A019/12/H/003/2019, de 2019-04-03), com armazém sito em Rua da Bica, n.º 15, Edifico Vipfarma I e II, Ninho do Mocho – Quinta do Estrangeiro, [...]

2019-11-04T22:10:57+00:0004.11.2019|Quality System and Audit, Regulatory Affairs|

EMA to provide guidance on avoiding nitrosamines in human medicines

EMA’s Executive Director has asked the human medicines committee (CHMP) to provide guidance for avoiding the presence of nitrosamine impurities in human medicines containing chemically synthesised active substances. 'We will continue to work with our partners to address the presence of nitrosamines and reassure patients about the quality of their medicines,' says the Executive Director Professor Guido [...]

FDA warns company for putting consumers at risk with drug manufacturing data integrity violations

Today the U.S. Food and Drug Administration posted a warning letter to Ningbo Huize Commodity Co., an over-the-counter (OTC) drug manufacturer, for significant current good manufacturing practice (CGMP) violations, including data integrity issues. “Americans deserve to have confidence in the quality of drugs the FDA regulates – from the prescription medicines they take to the over-the-counter products [...]

2019-09-02T21:27:23+00:0002.09.2019|Quality System and Audit, Regulatory Affairs|

(Cas) AEMPS: La UE y los EEUU alcanzan un hito en el reconocimiento mutuo de las inspecciones de los fabricantes de medicamentos

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 haberse completado la evaluación de los organismos de inspección, a partir del 11 de julio de 2019 se completa la [...]

2019-07-24T21:25:24+00:0024.07.2019|Quality System and Audit, Regulatory Affairs|

EMA: EU and US reach a milestone in mutual recognition of inspections of medicines manufacturers

With the recognition by the US Food and Drug Administration (FDA)of Slovakia, the European Union and the United States have now fully implemented the mutual recognition agreement (MRA) for inspections of manufacturing sites for certain human medicines in their respective territories. “We welcome the implementation of this agreement, which means authorities on both sides of the Atlantic will [...]

2019-07-17T20:37:39+00:0017.07.2019|Quality System and Audit, Regulatory Affairs|

Infarmed: Declaração CE de conformidade falsa de dispositivos médicos do fabricante Sri Trang Agro-Industry Public Company Ltd (mercado europeu)

Foi identificada, no mercado europeu, a existência de uma Declaração CE de Conformidade falsa, relativa a vários produtos alegadamente do fabricante Sri Trang Agro-Industry Public Company Ltd (Tailândia) e mandatário Sungo Certification Company Ltd (Reino Unido). Este fabricante informou que apenas coloca no mercado europeu luvas de exame e tem como mandatário a empresa Medical [...]

2019-07-08T20:40:06+00:0008.07.2019|Quality System and Audit, Regulatory Affairs|

EMA: One additional country to benefit from EU-US mutual recognition agreement for inspections

On 26 June 2019, Germany was included into the mutual recognition agreement between the European Union and the United States Food and Drug Administration (FDA). The FDA thus confirmed the capability of this additional EU Member State to carry out good manufacturing practice (GMP) inspections at a level equivalent to the US. The agreement mutually recognises inspections of manufacturing sites [...]

2019-07-02T21:39:25+00:0002.07.2019|Quality System and Audit, Regulatory Affairs|