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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|

ANSM: Cannabis à visée thérapeutique en France: l’ANSM souscrit au cadre de la phase expérimentale de mise à disposition proposé par le Comité d’experts

L’Agence nationale de sécurité du médicament et des produits de santé (ANSM) souscrit aux propositions du groupe d’experts (CSST) publiées le 28 juin sur le cadre pratique de l’accès au cannabis à visée thérapeutique en vue d’une expérimentation en France. L’agence et le ministère des solidarités et de la santé engagent dès à présent les [...]

2019-07-17T20:35:26+00:0017.07.2019|Drug Development Strategy, Regulatory Affairs|

FDA Guidance for Industry: Risk Evaluation and Mitigation Strategies: Modifications and Revisions

This guidance provides information on how the FDA defines the types of changes to approved risk evaluation and mitigation strategies (REMS), how application holders should submit changes to an approved REMS, and how the FDA will process submissions from application holders for changes to REMS. Specifically, this guidance provides information, as described in section 505-1(h) [...]

2019-07-15T20:38:35+00:0015.07.2019|Regulatory Affairs, Training|

Infarmed: Suspensão da autorização de distribuição por grosso de medicamentos de uso humano (Milanta Investiments Limited – sucursal em Portugal)

Na sequência da deteção de irregularidades em sede de inspeção, o Infarmed suspendeu a autorização para o exercício da atividade de distribuição por grosso de medicamentos de uso humano da entidade Milanta Investiments Limited – Sucursal em Portugal (autorização n.º A065/14/H/002/2017, de 24 de agosto de 2017), com armazém sito Estrada do Alcolombal n.º 95, [...]

2019-07-15T20:22:18+00:0015.07.2019|Regulatory Affairs|

FDA Guidance for Industry: Compliance Policy for Certain Compounding of Oral Oxitriptan (5-HTP) Drug Products for Patients With Tetrahydrobiopterin (BH4) Deficiency Immediately in Effect

This guidance describes the Food and Drug Administration’s (FDA, we, or the Agency) policy concerning the conditions under which the Agency does not generally intend to take regulatory action against a licensed pharmacist in a State-licensed pharmacy or Federal facility or a licensed physician using the bulk drug substance oxitriptan (also known as 5-hydroxytryptophan or [...]

2019-07-15T20:17:15+00:0015.07.2019|Regulatory Affairs, Training|

ANSM: Application du règlement européen relatif aux dispositifs médicaux: l’ANSM met en place une phase pilote pour la partie investigations cliniques

Afin de préparer la mise en application des dispositions du règlement européen relatif aux dispositifs médicaux (DM) portant sur les investigations cliniques (IC), l’ANSM met en place une phase pilote, en lien avec les parties prenantes concernées : représentants des promoteurs académiques et industriels, des Comités de protection des personnes (CPP), de la Commission nationale [...]

2019-07-11T22:04:17+00:0011.07.2019|Regulatory Affairs|

EMA: Medicine shortages: EU network takes steps to improve reporting and communication

The European Union task force set up to address problems with medicines supply has published two documents today: guidance for marketing authorisation holders on reporting of shortages in the EU good practice guidance for communication to the public on medicines’ availability issues The task force was established by EU regulators to better address potential problems with [...]

2019-07-10T21:03:57+00:0010.07.2019|Regulatory Affairs|

(Cas) AEMPS: Llamada a los promotores para que publiquen los resultados de sus ensayos clínicos

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 Unión Europea recuerda a los promotores de ensayos clínicos la obligación de publicar toda la información sobre el protocolo y [...]

2019-07-10T20:56:53+00:0010.07.2019|Drug Development Strategy, Regulatory Affairs|

FDA approves new treatment for refractory multiple myeloma

Today, the U.S. Food and Drug Administration granted accelerated approval to Xpovio (selinexor) tablets in combination with the corticosteroid dexamethasone for the treatment of adult patients with relapsed refractory multiple myeloma (RRMM) who have received at least four prior therapies and whose disease is resistant to several other forms of treatment, including at least two [...]

2019-07-10T20:50:32+00:0010.07.2019|Drug Development Strategy, Regulatory Affairs|

EMA: Call for all sponsors to publish clinical trial results in EU database

The European Commission (EC), the European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) have co-signed a letter reminding all sponsors of clinical trials conducted in the European Union of their obligation to make summaries of results of concluded trials publicly available in the EU Clinical Trials Database (EudraCT). Transparency and public access to clinical trial results, whether positive or negative, are [...]

2019-07-10T20:45:44+00:0010.07.2019|Drug Development Strategy, Regulatory Affairs|

FDA Statement on steps to make health care professional and patient labeling information for prescription medications consistent and clear

The FDA is committed to making sure that health care professionals and patients have up-to-date, accurate and actionable information about prescription medications so that informed treatment decisions can be made. We recognize that the choice of which medication to use, if any, for a particular patient is often a complex decision. These decisions involve a [...]

2019-07-08T20:59:09+00:0009.07.2019|Pharmacovigilance, 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|

FDA approves first treatment for neuromyelitis optica spectrum disorder, a rare autoimmune disease of the central nervous system

The U.S. Food and Drug Administration today approved Soliris (eculizumab) injection for intravenous use for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive. NMOSD is an autoimmune disease of the central nervous system that mainly affects the optic nerves and spinal cord. “Soliris provides the first [...]

2019-07-08T20:25:11+00:0008.07.2019|Drug Development Strategy, Regulatory Affairs|

EMA: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 24-27 June 2019

Three new medicines recommended for approval EMA’s human medicines committee (CHMP) recommended three medicines for approval at its June 2019 meeting. The Committee recommended granting a marketing authorisation for Giapreza (angiotensin II), for the treatment of refractory hypotension in adults with septic or other distributive shock. Two informed consent applications received a positive opinion from the CHMP: Azacitidine Celgene (azacitidine), for the treatment [...]

EMA: New treatment for children with type 2 diabetes

EMA’s human medicines committee (CHMP) has recommended granting an extension of indication to Victoza (liraglutide) to include the treatment of children and adolescents aged 10 years or older with type 2 diabetes. This medicine is already approved for use together with diet and exercise in adults with type 2 diabetes, on its own or as an add-on [...]

2019-07-08T20:02:56+00:0008.07.2019|Drug Development Strategy, 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|

(Cas) AEMPS: Boletín mensual de la AEMPS sobre medicamentos de uso humano del mes de mayo de 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.Recoge nuevos medicamentos, cambios de especial interés en medicamentos ya autorizados, información sobre seguridad y otra información de interés. En la sección [...]

(Cas) AEMPS: Información a los laboratorios titulares de medicamentos de uso humano que contienen “Ésteres etílicos de ácidos omega 3” administrados por vía oral para la prevención secundaria después de un infarto de miocardio. Decisión de la Comisión C(2019) 4336 final, de fecha 6.6.2019. (Nº EMA: EMEA/H/A-31/1464)

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 [...]

2019-07-02T21:37:12+00:0002.07.2019|Regulatory Affairs|

FDA approves first treatment for chronic rhinosinusitis with nasal polyps

The U.S. Food and Drug Administration today approved Dupixent (dupilumab) to treat adults with nasal polyps (growths on the inner lining of the sinuses) accompanied by chronic rhinosinusitis (prolonged inflammation of the sinuses and nasal cavity). This is the first treatment approved for inadequately controlled chronic rhinosinusis with nasal polyps. “Nasal polyps can lead to [...]

2019-07-02T20:33:39+00:0002.07.2019|Drug Development Strategy, Regulatory Affairs|