Search Results for ANSM

Showing 1 – 25  of 26

European Regulatory Roundup: Commission Begins Investigation Into Cancer Drug Prices (18 May 2017) By Nick Paul Taylor - Published 18 May 2017

Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.

Categories: News, Europe, EC, EMA, Biologics and biotechnology, Drugs, Government affairs

Tags: European Regulatory Roundup, EU roundup of pharma news, Aspen, personalized medicine, ANSM

European Regulatory Roundup: UK Hurries Drug Pricing Bill Ahead of Election (4 May 2017) By Nick Paul Taylor - Published 04 May 2017

Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.

Categories: News, Europe, EC, EMA, Drugs

Tags: drug pricing, ANSM, UK election

ANSM Says Pilot for New Clinical Trials Regulation Enforcement a Success By Michael Mezher - Published 26 January 2017

France's Agency Nationale de Sécurité du Médicament et des Produits de Santé (ANSM) on Wednesday reported positive results for its year-long pilot for assessing clinical trials using the process established in the new EU Clinical Trials Regulation.

Categories: News, Europe, Clinical

Tags: ANSM, Clinical Trials Regulation

What to do if a Device Manufacturer’s Notified Body Halts Operations? France’s ANSM Explains By Zachary Brennan - Published 14 November 2016

For several months now, notified bodies in the EU have ceased operations, either voluntarily or following a de-notification decision from their member state’s competent authority.

Categories: News, Europe, EC, Business and Leadership, Government affairs, Labeling, Medical Devices, Regulatory intelligence, Regulatory strategy, Submission and registration

Tags: ANSM, CE marking, notified bodies

French Regulators Raise Serious Concerns With Indian API Manufacturer By Zachary Brennan - Published 10 October 2016

France’s National Agency for Medicines and Health Products Safety (ANSM) on Monday released a new statement of serious good manufacturing practice (GMP) non-compliance for India-based active pharmaceutical ingredient (API) manufacturer Nandu Chemicals Industries.

Categories: News, Europe, EC, EMA, Active pharmaceutical ingredients, Compliance, Crisis management, Government affairs, Manufacturing

Tags: ANSM, Indian API manufacturer, Nandu Chemicals, statement of non-compliance

Seven Pharmaceutical Regulators and NIH Collaborate to Build Drug Ingredient Database By Zachary Brennan - Published 20 April 2016

Drug regulators from the US, Europe, Canada, France, Netherlands, Germany and Switzerland are attempting to build a database of substances used in medicinal products to ease the exchange of such information.

Categories: News, Canada, Europe, US, EMA, FDA, Health Canada, ISO, WHO, Active pharmaceutical ingredients, Compliance, Crisis management, Postmarket surveillance, Quality

Tags: API database, ANSM, Swissmedic, ICH, NCATS

UK, French Regulators Call Out Two Noncompliant Indian Pharma Sites By Zachary Brennan - Published 04 April 2016

UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) and France’s ANSM (National Agency for Medicines and Health Products Safety) have sent notices of noncompliance to two Indian pharmaceutical companies that restrict the dissemination of their products in Europe.

Categories: News, India, Europe, EC, MHRA, Drugs, Due Diligence, Ethics, Government affairs, Manufacturing, Postmarket surveillance, Product withdrawl and retirement

Tags: MHRA, ANSM, Indian pharmaceutical manufacturing, noncompliant pharmaceutical companies

ANSM Committee Delves Into Nitty-Gritty of Fatal French Phase I Trial By Zachary Brennan - Published 10 March 2016

France’s National Agency for Medicines and Health Products Safety (ANSM) released a report this week outlining how its Temporary Specialist Scientific Committee (TSSC) evaluated what went wrong with a first-in-man clinical trial in Rennes, France that resulted in the death of one healthy volunteer and the hospitalization of five others in January.

Categories: News, Europe, EMA, Clinical, Crisis management, Drugs, Government affairs, Preclinical, Quality

Tags: ANSM, EMA, Bial, Biotrial, French clinical trial, Phase I trial death

Chinese Heparin Sourcing Questions Resurface After ANSM Inspection By Zachary Brennan - Published 01 March 2016

France's National Agency for Medicines and Health Products Safety (ANSM) raised two critical deficiencies over a Chinese pharmaceutical company’s manufacture of heparin, which harkens back to the scandal from 2007 and 2008 when heparin sourced from Chinese manufacturers killed 149 Americans.

Categories: News, China, Europe, EMA, FDA, Active pharmaceutical ingredients, Compliance, Drugs, Due Diligence, Manufacturing, Product withdrawl and retirement, Quality, Reimbursement, Research and development

Tags: Heparin manufacturing, Chinese Heparin, ANSM, drug manufacturing deficiencies

Updated: European Commission: Cranberry-Derived Products are not Medical Devices By Zachary Brennan - Published 23 February 2016

The European Commission has released a draft decision that would mean the group of products depending on proanthocyanidins present in cranberry (Vaccinium Macrocarpon) extract, in order to prevent or treat cystitis, also known as bladder inflammation or infection, should not be classified as medical devices.

Categories: News, Europe, EC, Active pharmaceutical ingredients, Crisis management, Government affairs, Nutritional and dietary supplements, Product withdrawl and retirement, Research and development

Tags: cranberry products, UTIs, urinary tract infections, Medical Brands, ANSM

Phase I Death in France: An Update on ANSM’s Investigations By Zachary Brennan - Published 05 February 2016

New information from France’s National Agency for Medicines and Health Products Agency (ANSM) was released this week on the Phase I clinical trial halted last month after the death of one healthy volunteer and the hospitalizations of five others.

Categories: News, Europe, EMA, Clinical, Crisis management, Drugs, Quality, Research and development

Tags: ANSM, Bial, Biotrial, France clinical trial

FDA Conferring With EU Counterparts on Trial Fiasco in France By Zachary Brennan - Published 22 January 2016

The US Food and Drug Administration (FDA) announced Friday that it is conferring with European regulators, including the European Medicines Agency (EMA) and France's ANSM after a Phase I trial resulted this week in the death of one enrolled subject and neurological injury to four others.

Categories: News, US, EMA, FDA, Clinical, Crisis management, Drugs, Research and development

Tags: Biotrial, Bial, ANSM, EMA, FDA

EMA Will Assess ANSM Review of Botched Clinical Trial in France By Zachary Brennan - Published 19 January 2016

EU authorities could end up revising clinical trial guidelines depending on the outcome of French regulators’ investigation into Biotrial’s halted Phase I trial that has resulted in the death of one volunteer and the hospitalizations of five others.

Categories: News, Europe, EC, EMA, Clinical, Crisis management, Ethics, Government affairs, Project management, Research and development

Tags: ANSM, Biotrial, EMA, Bial, clinical trial in France

France’s ANSM Investigating Trial Halted After Five Patients Hospitalized, One Brain-Dead By Zachary Brennan - Published 15 January 2016

France’s National Agency for Medicines and Health Products Safety (ANSM) is currently investigating a Phase I clinical trial that’s been halted after the investigational drug caused brain damage in one healthy volunteer and hospitalized five others.

Categories: News, Europe, EMA, Clinical, Crisis management, Drugs, Due Diligence, Quality, Regulatory strategy

Tags: ANSM, France, clinical trial, Biotrial, Rennes

European Regulatory Roundup: EMA Updates HRT Warning on Ovarian Cancer Risk (14 January 2015) By Nick Paul Taylor - Published 14 January 2016

Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.

Categories: News, Europe, EMA, ISO, MHRA, Clinical, Drugs, Medical Devices

Tags: HRT, ovarian cancer, ISO, ANSM, Danish Medicines Agency

French Regulators Suspend Catalent Manufacturing Site By Zachary Brennan - Published 16 November 2015

France’s health product regulator, l’Agence National de Sécurité du Médicament et des produits de santé (ANSM), suspended production at contract manufacturer Catalent’s softgel capsule manufacturing facility in Beinheim, France, on Friday.

Categories: News, Europe, Distribution, Drugs, Due Diligence, Manufacturing, Quality, Regulatory intelligence, Regulatory strategy

Tags: ANSM, France, French drug regulator, Catalent, softgel capsules

French Regulators Find Cargill Manufacturing Site Non-Compliant With GMPs By Zachary Brennan - Published 02 November 2015

France’s National Agency for Medicines and Health Products Safety (ANSM) has uncovered deficiencies at Cargill’s manufacturing site in Lannilis, France that have resulted in a major recall.

Categories: News, Europe, EMA, Active pharmaceutical ingredients, Drugs, Manufacturing, Quality, Regulatory intelligence, Regulatory strategy

Tags: ANSM, Cargill, excipients, alginic acid, Topaal, France drug manufacturing

French Regulator and Roche Trade Blows Over Off-Label Avastin Use By Michael Mezher - Published 25 June 2015

On Monday, Swiss drugmaker Roche announced its opposition to the use of its cancer drug Avastin to treat wet age-related macular degeneration (AMD) in France. The move is aimed squarely at France's drug regulator, who temporarily recommended the drug for AMD as a cost saving maneuver in April 2015.

Categories: News, Europe, Biologics and biotechnology, Labeling, Submission and registration

Tags: France, ANSM, Roche, Avastin, Lucentis, Wet AMD

EU Regulators Concerned About Drug Data Fraud by Indian Company By Alexander Gaffney, RAC - Published 08 December 2014

European regulatory officials have expressed concern that dozens of medicines may have been approved in the EU based on fraudulent data conducted by a contract testing facility in Hyderabad, India.

Categories: News, India, Europe, EMA, Audit, Clinical, Compliance, Generic drugs, Ethics, Submission and registration

Tags: Data Integrity, GVK Biosciences, ANSM, BfArM, Bioequivalence, Data

French Regulators find Cardiology Manufacturer Non-Compliant with Regulations, Withdraw Devices By Alexander Gaffney, RF News Editor - Published 15 May 2013

Tags: ANSM, France, cardiovascular, EU, medical device

French Regulator Back in Spotlight as Another Device is Alleged to Have Evaded Controls By Alexander Gaffney, RF News Editor - Published 03 May 2013

Tags: ANSM, France, French, medical device

French Regulator Charged with Manslaughter for Role in Diabetes Drug Scandal By Alexander Gaffney, RF News Editor - Published 22 March 2013

Tags: ANSM, Indictment, Servier, Mediator, Investigation, France, French, Latest News

CEO Charged with Manslaughter after Drug's Risks Brought to Light By Alexander Gaffney, RF News Editor - Published 12 December 2012

Tags: ANSM, Servier, AFSSAPS, France, French

France's ANSM Announces Launch of Nine Regulatory Pilot Projects By Alexander Gaffney, RF News Editor - Published 29 October 2012

Tags: Pilot Projects, ANSM, Funding, France, Latest News, regulatory

French Regulators Launch New Prescription Drug Paradigm Aimed at Limiting Off-Label Use By Alexander Gaffney - Published 08 October 2012

Tags: TRU, ANSM, Prescribing, Mediator, AFSSAPS, Off-label, France, Latest News