Archives: Food & Drug Regulatory

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MHRA Creates New Expert Advisory Group on Medical Devices

This post was originally published on our sister blog Inside Medical Devices. On 18 July 2014, the Medicines and Healthcare Products Regulatory Agency (MHRA) announced that it will create a new independent Devices Expert Advisory Committee (DEAC) before April 2015. The DEAC will be responsible for providing independent expert advice to help the MHRA regulate medical devices.  … Continue Reading

Commission Updates EU Medical Devices Borderline Manual

The European Commission’s Borderline and Classification Medical Devices Expert Group has published a new version of its Manual on Borderline and Classification in the Community Regulatory Framework for Medical Devices.  The updated manual includes a new section on software and mobile applications reflecting the growing industry of medical device software.  The manual also provides new … Continue Reading

European Commission Fines Servier and Five Generic Companies For Preventing Entry Of Generic Versions Of Blood Pressure Control Drug

On 9 July 2014, the European Commission’s Directorate General for Competition imposed fines totalling € 427.7 million on innovative pharmaceutical company Servier and generic companies Niche/Unichem, Matrix (now Mylan), Teva, Krka and Lupin.  The Commission’s decision was the result of proceedings opened in 2009 and follows a Statement of Objections sent to the parties involved … Continue Reading

EMA clarifies interpretation of new variation categories in an amended Q&A document

On 6 February 2014, the EMA released an amended Q&A document on the implementation of the new Variations Guidelines of 2013, which provides details on the different variation categories and the operation of procedures laid down in Commission Regulation 1234/2008 concerning the examination of variations to the terms of marketing authorizations for human and veterinary … Continue Reading

EMA launches adaptive licensing pilot project

On 19 March 2014, the EMA announced the launch of its adaptive licensing pilot project along with an invitation to interested companies to submit their ongoing medicine development programmes to be considered as pilot cases. The term “adaptive licensing” (also known as “staggered approval” or “progressive licensing”) describes a process which allows patients to have … Continue Reading

Update on the French Sunshine Rules

In August last year, we wrote about the extent to which the French “sunshine rules” apply to the medical devices industry (see our post), alongside the pharmaceutical and cosmetic industry, and other health-related industries. A number of developments have occurred since then. First, we highlighted in our previous post the uncertainty regarding the territorial scope … Continue Reading

New MHRA Guidance on Borderline Medical Devices

In February 2014, the MHRA published new guidance on borderline medical devices.  The guidance considers only medical devices within the terms of the Medical Device Directive and not the Active Implantable Medical Devices Directive or In Vitro Medical Devices Directive. Purpose and mode of action The MHRA makes clear that borderline determinations “will be based on the stated intended purpose of … Continue Reading

International Consensus on “Software as Medical Device” Definition

Last month, the International Medical Device Regulators Forum (IMDRF) reached a consensus on a potentially key aspect of the future regulation of medical software in the US, the EU, Brazil, Canada and Japan, that is, a harmonized definition of when stand-alone software will be considered to be a medical device. This category of software, dubbed … Continue Reading

Call for expression of interest to participate in early dialogue between HTA bodies and healthcare product developers

A call for expression of interest addressed to healthcare product developers who would be interested in engaging in early dialogues (EDs) with Health Technology Assessment (HTA) bodies was launched in December 2013 and will stay open until October 2014.  The call concerns developers of both medicinal products and medical devices. The European Commission defines HTA … Continue Reading

EMA Releases Its First Product-Specific Guidance on the Demonstration of Bioequivalence for Public Consultation

On 15 November 2013, the EMA released the first draft product-specific guidance documents on the demonstration of bioequivalence for 16 active substances for public consultation. This first set of guidance builds upon the general principles set out in the Agency’s Guideline on the investigation of bioequivalence of 2010, which specified the requirements for the design, … Continue Reading

Privacy Impact Assessments – Soon Compulsory for Companies in the Life Sciences Industry?

Privacy Impact Assessments (PIAs) or  data protection impact assessments used to be discussed in the context of specific technologies or industry sectors (see, for instance, the European Commission’s recommendations in relation to  applications supported by radio-frequency identification (RFID) and the development of smart grids). However, this situation is about to change. PIAs are increasingly being promoted by … Continue Reading

French Sunshine Rules and the Medical Devices Industry

This post originally appeared on our sister blog, InsideMedicalDevices.   At the end of May 2013, the French government released the long awaited Decree implementing the 2011 French Sunshine Act.  The Decree requires companies to publicly disclose — in French — any benefit over 10 Euros and agreements (except commercial ones) concluded with healthcare professionals or other actors active in the … Continue Reading

PARNUTS: Out with the Old and in with the New

Regulation (EU) No 609/2013 on food intended for infants and young children, food for special medical purposes and total diet replacement for weight control, was published in the Official Journal of the European Union on 12 June 2013.  The new Regulation allows the Commission to create specific compositional and information requirements and update the list … Continue Reading

Lead Member of the European Parliament Proposes a Pre-Marketing Authorization System

This post originally appeared on our sister blog, InsideMedicalDevices.   As announced in our previous post, the rapporteur (i.e., the leader of the parliamentary process) for the new Regulation on medical devices, Mrs. Dagmar ROTH-BEHRENDT, has proposed the introduction of a pharma-like pre-marketing authorization regime for high risk medical devices in the EU. In her recent report submitted to the ENVI Committee of the European Parliament (the parliamentary committee … Continue Reading

Spain: Proposed New Legislation on Clinical Trials

The Spanish Ministry of Health has published a draft Royal Decree on Clinical Trials, which the Spanish government is expected to adopt by the end of this year.  Once adopted, the new Royal Decree will replace Royal Decree 223/2004 on Clinical Trials and will regulate all clinical trials with medicines and medical devices in Spain. … Continue Reading

EMA Publishes Draft Guideline on the Use of Phthalates in Medicines

EMA has published a draft guideline on the use of phthalates as excipients in human medicinal products. The guideline establishes new Permitted Daily Exposure (“PDE”) values for the following phthalates that are among the most commonly used as excipients in medicinal products: dibutyl phthalate: 0.01 mg/kg/day diethyl phthalate: 4 mg/kg/day polyvinyl acetate phthalate: 2 mg/kg/day … Continue Reading

Advocate General Opinion on Reclassification of Medical Devices

On May 30, 2013, Advocate General Sharpston delivered an opinion on a request for a preliminary ruling from the Finnish national courts concerning the laws governing reclassification of medical devices (Advocate General: Opinion, Case C-109/12).  The Advocate General’s opinion does not bind the Court of Justice of the European Union (CJEU).  However, in the majority … Continue Reading

Commission Recommendation on Unique Device Identification System in the EU

On 5 April, 2013 the European Commission adopted a recommendation on a common framework for a unique device identification (UDI) system in the EU. The hope is that a harmonized UDI system will facilitate device safety monitoring and reporting, recalls and other field safety corrective actions. It will also help avoid device-related medical errors and injuries … Continue Reading

“Notified Bodies” Under EU Device Regulations: Under Stricter Control But With More Power

This post originally appeared on our sister blog, InsideMedicalDevices. Unlike in the US, medical devices in the EU are not subject to a premarket authorization by a competent authority but instead to a conformity assessment procedure.  For low-risk devices, the manufacturer conducts this conformity assessment procedure, whereas for medium and high risk devices, independent third parties, so-called “Notified … Continue Reading

EU Proposes a Scrutiny Procedure for High-Risk Devices

This post originally appeared on our sister blog, InsideMedicalDevices. Following recent developments regarding breast implants and metal-on-metal hip joint replacements, the European Parliament (EP) adopted a resolution calling for safer medical devices and the introduction of a marketing authorization system for high-risk devices.  While the Commission has not endorsed the EP’s resolution for a premarket authorization system in its Proposal for a new EU medical devices’ … Continue Reading

New UK Guidance for Doctors on Prescribing Medical Devices and Medicines

This post originally appeared on our sister blog, InsideMedicalDevices. The General Medical Council in the UK has issued new prescribing guidance for doctors that includes detailed provisions on prescribing medical devices and managing patients using medical devices. The GMC’s previous guidance was focused almost exclusively on medicines.  The new guidance recognizes that medical devices — particularly software-based devices … Continue Reading

Innovation vs. Safety: The New Proposed Rules for Medical Devices in the European Union

Article originally published in the FDLI Update (January/February 2013) “Being able to use innovative products at the earliest possible time – and in Europe we deliver innovation about three years before our American counterparts with their own system – is a benefit to patients that we cannot put aside.” This is how former European Union … Continue Reading

Proposed EU Rules Impact Commercial Testing Laboratories

This post originally appeared on our sister blog, InsideMedicalDevices. The European Commission has proposed a revision to the regulatory framework for in vitro diagnostic medical devices (IVDs) that could have a significant impact on the operations of commercial laboratories in the EU or those offering testing services to customers in the EU. Laboratory-Developed Tests Under current EU … Continue Reading
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