> Quality System and Audit

FDA sends warning to company for marketing dangerous unapproved stem cell products that put patients at risk and puts other stem cell firms, providers on notice

The U.S. Food and Drug Administration has warned Genetech, Inc. of San Diego, California and its president, Edwin N. Pinos for marketing stem cell products without FDA approval and for significant deviations from current good tissue practice (CGTP) and current good manufacturing practice (CGMP) requirements, including some violations that may have led to microbial contamination, potentially causing [...]

(Cas) AEMPS: Declaración Responsable de actividades de fabricación y/o importación de Productos Cosméticos. Actualización de la información y de los modelos para su presentación

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 17 de diciembre de 2018 se ha actualizado la información y los modelos de Declaración Responsable de actividades de fabricación [...]

2018-12-20T23:01:00+00:0021.12.2018|Quality System and Audit, Regulatory Affairs|

ANSM: Lancement d’une consultation publique – Projet de transposition des lignes directrices relatives aux bonnes pratiques de fabrication européennes spécifiques aux médicaments de thérapie innovante

La transposition des Lignes directrices du 22 novembre 2017 relatives aux bonnes pratiques de fabrication européennes (BPF) des médicaments de thérapie innovante (MTI) est soumise à consultation publique. Les BPF-MTI ont été adoptées par la Commission européenne le 22 novembre 2017 et ont intégré la partie IV du volume 4 d’Eudralex. Par ailleurs, une nouvelle [...]

2018-12-18T17:04:49+00:0018.12.2018|Quality System and Audit, Regulatory Affairs|

FDA warns API manufacturer involved in valsartan recall, provides information for patients taking these medications

The U.S. Food and Drug Administration today released a warning letter issued to Zhejiang Huahai Pharmaceutical Co. Ltd. (ZHP), in Linhai, Taizhou Zhejiang China, the manufacturer of the active pharmaceutical ingredient (API) found in valsartan that is the subject of an ongoing FDA investigation into probable cancer-causing impurities in certain commonly prescribed heart medicines. The letter outlines [...]

(Cas) AEMPS: Información de la AEMPS sobre las garantías sanitarias de los productos sanitarios

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 las garantías sanitarias de los productos sanitarios. Los productos sanitarios [...]

2018-12-07T11:01:15+00:0007.12.2018|Quality System and Audit, Regulatory Affairs|

EMA: Five additional countries to benefit from EU-US mutual recognition agreement for inspections

In November 2018, the US Food and Drug Administration (FDA) confirmed the capability of five additional EU Member States to carry out good manufacturing practice (GMP) inspections at a level equivalent to the United States (US). Belgium, Denmark, Finland and Latvia were included into the mutual recognition agreement between the European Union (EU) and the United States (US) on 16 November and Estonia on 28 November [...]

2018-12-02T23:50:18+00:0003.12.2018|Quality System and Audit, Regulatory Affairs|

EMA: Valsartan from Mylan laboratories in India can no longer be used in EU medicines due to NDEA impurity

Authorities in the EU are taking action after an impurity, N-nitrosodiethylamine (NDEA), was found in some batches of valsartan made by Mylan Laboratories Limited in Hyderabad, India. EDQM has now suspended the manufacturer’s CEP (a certificate of compliance with European standards for quality testing), effectively prohibiting the use of its valsartan in EU medicines. In addition, national [...]

FDA warns StemGenex Biologic Laboratories LLC of illegally marketing an unapproved cellular product manufactured in a facility with significant manufacturing violations, putting patients at risk

The U.S. Food and Drug Administration has warned StemGenex Biologic Laboratories LLC (StemGenex) of San Diego, Calif; its owner/manager Rita F. Alexander and laboratory and medical director Jenny R. Galloway, M.D. about marketing a purported stem cell product without FDA approval and for significant deviations from current good manufacturing practice requirements, including some that could lead to [...]

(Cas) AEMPS: Distribución irregular de principios activos por la empresa Intabiotech SLU, concesionaria de ND Pharma & Biotech

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. Nota informativa sobre la distribución de principios activos sin cumplir con las obligaciones y los controles de calidad exigidos en la [...]

2018-10-21T11:39:33+00:0021.10.2018|Quality System and Audit, Regulatory Affairs|

EMA: EU authorities take further action in ongoing review of sartans: Zheijiang Huahai placed under increased supervision; Aurobindo Pharma stopped from supplying irbesartan to the EU

EU authorities are placing the Chinese company Zheijiang Huahai under increased supervision following European and US inspections which revealed weaknesses in quality management at the company’s Chuannan site in Linhai, China. The inspection findings included deficiencies in the way the company investigated impurities in its valsartan products and led EU authorities to issue a statement of non-compliance with [...]

2018-10-17T20:12:18+00:0017.10.2018|Pharmacovigilance, Quality System and Audit|

Infarmed: Autoridade da Concorrência e Infarmed assinaram protocolo de cooperação

A Autoridade da Concorrência (AdC) e o Infarmed assinaram hoje um protocolo inédito de cooperação para a constituição de instrumentos de articulação e de intercâmbio de informação, capazes de incrementar a eficácia de atribuições e competências das duas entidades. A deteção atempada de falhas de mercado ou distorções concorrenciais é um dos objetivos partilhados pela [...]

2018-09-24T19:03:12+00:0025.09.2018|Quality System and Audit, Regulatory Affairs|

EMA: Portugal to also benefit from EU-US mutual recognition agreement for inspections

Agreement now operational between 15 EU Member States and FDA The mutual recognition agreement between the European Union (EU) and the United States (US) to recognise inspections of manufacturing sites for human medicines conducted in their respective territories has made further progress. The US Food and Drug Administration (FDA) confirmed on 14 September 2018 the capability of one additional EU Member [...]

2018-09-24T18:55:46+00:0025.09.2018|Quality System and Audit, Regulatory Affairs|

L’ANSM engagée dans une coordination internationale pour l’inspection des fabricants de substances actives

La supervision des fabricants de substances actives en pays tiers à l’espace économique européen représente un enjeu sanitaire majeur pour les autorités compétentes européennes. C’est pourquoi l’ANSM est impliquée depuis 2008 dans une collaboration internationale sur l’inspection des fabricants de substances actives. Ce réseau permet de partager des informations sur les inspections des Bonnes Pratiques [...]

2018-09-24T18:20:04+00:0024.09.2018|Quality System and Audit, Regulatory Affairs|

Infarmed: Food and Drug Administration (FDA) reconhece qualidade das inspeções do Infarmed

A Food and Drug Administration (FDA), autoridade reguladora do medicamento dos Estados Unidos, reconheceu a capacidade e a qualidade das inspeções desenvolvidas pelo Infarmed. Isto significa que a FDA deixará de realizar inspeções em Portugal e vai reconhecer os resultados associados às inspeções de Boas Práticas de Fabrico de medicamentos realizadas pelo Infarmed. Além de [...]

2018-09-20T22:39:21+00:0021.09.2018|Quality System and Audit, Regulatory Affairs|

FDA global efforts to help assure product quality and transparency at foreign drug manufacturing facilities

Over the past 25 years, globalization of drug manufacturing has prompted the FDA to change its regulatory landscape. The shift to overseas production of U.S. goods, including some drugs and their components, predominantly occurred in the early 2000s. It added new complexities to our supply chain. This required the FDA to take different steps to [...]

2018-09-05T21:56:10+00:0005.09.2018|Quality System and Audit, Regulatory Affairs|

EMA: EU and Japan reinforce their collaboration on inspections of medicine manufacturers

Update of 2004 mutual recognition agreement extends scope to sterile products, active pharmaceutical ingredients and biologicals including vaccines The European Union (EU) and Japan have agreed to broaden the range of medicines for which they will recognise each other’s inspections of manufacturing sites. The current mutual recognition agreement (MRA) between the EU and Japan has been operational since 29 [...]

2018-07-22T10:36:19+00:0022.07.2018|Quality System and Audit, Regulatory Affairs|

(Cas) AEMPS: Consideraciones sobre los productos sanitarios utilizados para la obtención de células autólogas y la clasificación del producto resultante como medicamento de terapia avanzada

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 informa sobre la consideración que tienen los productos sanitarios que se ofrecen para [...]

2018-07-15T21:51:20+00:0016.07.2018|Quality System and Audit, Regulatory Affairs|

L’ANSM confirme la bonne qualité de la nouvelle formule du Levothyrox

Suite aux résultats d’analyses sur la nouvelle formule de Levothyrox récemment rendus publics par l’Association française des malades de la thyroïde (AFMT), l’ANSM a réalisé dans ses laboratoires de nouveaux contrôles sur des comprimés de Levothyrox nouvelle formule et ancienne formule (Euthyrox) qui visaient à confirmer la conformité du principe actif (lévothyroxine). Les analyses chromatographiques (05/07/2018)  (729 ko) démontrent [...]

2018-07-05T22:05:41+00:0006.07.2018|Pharmacovigilance, Quality System and Audit|

EMA: Reinforced EU/US collaboration on medicines

Update on the European Commission/EMA–FDA bilateral of 18-19 June 2018 Senior officials from the European Commission (EC), the European Medicines Agency (EMA) and the United States Food and Drug Administration (FDA) held their 2018 bilateral meeting in Brussels, Belgium, on 18 and 19 June. The two-day bilateral regulatory dialogue allowed the strategic partners to review their ongoing cooperative initiatives, [...]

2018-06-26T21:37:37+00:0026.06.2018|Quality System and Audit, Regulatory Affairs|