> Quality System and Audit

ANSM: Grossistes-répartiteurs: l’ANSM prend des mesures à l’encontre des “short-liners”

Face aux enjeux des ruptures de stock et aux risques d’introduction de médicaments falsifiés dans le circuit légal, l’ANSM a poursuivi en 2018 ses actions vis-à-vis des grossistes-répartiteurs. Les inspections, conduites par les Agences Régionales de Santé (ARS) en lien avec l’ANSM, ont mis en évidence qu’il existe encore des grossistes-répartiteurs qui ne remplissent pas [...]

2019-05-09T22:40:51+00:0009.05.2019|Quality System and Audit, Regulatory Affairs|

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

In April 2019, the US Food and Drug Administration (FDA) confirmed the capability of two additional European Union Member States to carry out good manufacturing practice (GMP) inspections at a level equivalent to the United States (US). Bulgaria and Cyprus were included into the mutual recognition agreement between the EU and the US on 29 April 2019. The agreement mutually recognises inspections of manufacturing sites [...]

2019-05-05T21:14:04+00:0005.05.2019|Quality System and Audit, Regulatory Affairs|

Infarmed: Novo portal Inspeção+ simplifica a gestão de processos de inspeção

Inspeção + é o nome do novo portal do Infarmed que pretende simplificar a gestão de processos de inspeção. À semelhança do desenvolvimento de outras plataformas informáticas no Infarmed também este portal surge no âmbito do SIMPLEX+, visando, entre outros aspetos, a desmaterialização e agilização da conclusão dos processos de inspeção às entidades do circuito [...]

2019-04-12T20:37:56+00:0012.04.2019|Quality System and Audit, Regulatory Affairs|

EMA: EU and Switzerland to improve information-sharing on good manufacturing practice through use of the EudraGMDP database

The Swiss Agency for Therapeutic Products (Swissmedic) has started in 2019 to enter information on Good manufacturing practice (GMP) compliance as well as on manufacturing authorisations related to Swiss manufacturers into the European Union’s EudraGMDP database. This applies for all new or renewed manufacturing authorisations and the related GMP-certificates issued using new templates (similar to those of EMA). This [...]

2019-02-21T22:15:31+00:0022.02.2019|Quality System and Audit, Regulatory Affairs|

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

In February 2019, the US Food and Drug Administration (FDA) confirmed the capability of two additional European Union Member States to carry out good manufacturing practice (GMP) inspections at a level equivalent to the United States (US). Poland and Slovenia were included into the mutual recognition agreement between the EU and the US on 7 February 2019. The agreement mutually recognises inspections of manufacturing [...]

2019-02-13T18:52:28+00:0013.02.2019|Quality System and Audit, Regulatory Affairs|

(Cas) AEMPS: Presencia de nitrosaminas en los medicamentos denominados “sartanes”. Conclusión de la revisión de la Agencia Europea 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. El Comité de Medicamentos de Uso Humano (CHMP) de la Agencia Europea de Medicamentos (EMA) ha concluido el arbitraje realizado por [...]

2019-02-12T20:41:32+00:0013.02.2019|Quality System and Audit, Regulatory Affairs|

EMA launches checklist to facilitate validation for initial marketing authorisation applications

A survey launched by EMA in September 2016 shows that validation issues occur in 90% of initial marketing authorisation applications (MAAs). They create additional workload for companies and potential delays at a critical moment for the timely start of the procedure. To make the validation process more efficient, predictable and easier to navigate, EMA is encouraging applicants [...]

EMA: Sartan medicines: companies to review manufacturing processes to avoid presence of nitrosamine impurities

Companies that make sartan blood pressure medicines (also known as angiotensin II receptor blockers) are being required to review their manufacturing processes so that they do not produce nitrosamine impurities. Companies will have a transition period to make any necessary changes, during which strict temporary limits on levels of these impurities will apply. After this [...]

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|