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EMA Publishes Proactive Disclosure Guidance

On 2 March 2016, the European Medicines Agency (EMA) published guidance on aspects of the Agency’s proactive disclosure policy for clinical reports (Policy 0070).  The latest Proactive Disclosure Guidance can be found here and focuses on: Procedural aspects of submitting clinical reports. The anonymisation of clinical reports. The identification and redaction of commercially confidential information … Continue Reading

EU Agreement on a General Approach on the Medical Devices Package

This article was originally posted on our sister blog Inside Medical Devices On October 5, 2015, after three years of continued discussions and negotiations on the modernization of EU medical devices and IVD rules, the Council of Ministers of the EU countries (“the Council”) agreed on a full General Approach on the review of the … Continue Reading

MHRA grants second scientific opinion as part of the Early Access to Medicines Scheme

The UK Medicines and Healthcare Products Regulatory Agency (MHRA) has granted a second positive scientific opinion as part of the Early Access to Medicines Scheme (EAMS).  EAMS is a UK specific scheme that supports earlier access of unlicensed medicines in patients with seriously debilitating or life threatening conditions where there is an unmet medical need. … Continue Reading

General Court Confirms Market Exclusivity Rights in CTRS Case

On 11 June 2015, the General Court handed down its judgment in Case T-452/14 Laboratoires CTRS v European Commission (the “CTRS Case”) annulling the Commission’s decision to grant Kolbam a marketing authorisation.  The General Court held that references in Kolbam’s SmPC to the efficacy of Kolbam for indications that Orphacol was authorised circumvented Orphacol’s market … Continue Reading

EFSA Grants Public Access to Data through Scientific “Data Warehouse”

The European Food Safety Authority (EFSA) is launching an ambitious project of public access to data that it collects and holds through the launch of a scientific “data warehouse.” EFSA announced this initiative on March 2, 2015, with the aim to create an “open science organisation” and increase public access to data that it holds. … Continue Reading

Article 29 Working Party Clarifies Scope of Health Data in Apps and Devices

Article originally posted on our sister blog InsidePrivacy The Article 29 Data Protection Working Party (Working Party), an independent EU advisory body on data protection and privacy, responded to a request from the European Commission made in the framework of the Commission’s  mHealth initiative to clarify the definition of data concerning health in relation to lifestyle and wellbeing … Continue Reading

EMA Transparency Policy – EMA Launches Public Consultation On The Publication Of Information Under The New EU Clinical Trials Regulation

On 21 January 2015, the European Medicines Agency (“EMA”) launched a public consultation on how the transparency rules of Regulation EU No 536/2014 (the “Clinical Trials Regulation”) should apply to the new clinical trials database.  The consultation document of the EMA discusses the practical application of the new transparency rules, sets different options on the … Continue Reading

New French Rules On Off-Label Use

France has enacted new rules on the off-label use of medicines.  A new Decree amending the rules on Temporary Recommendations for Use (“RTU”) established pursuant to Article L5121-12-1 of the French Public Health Code (“PHC”) was published on 31 December 2014 (the “Decree”).  This Decree follows the adoption of the amended social security budget bill … Continue Reading

Comprehensive New EU Food Labeling Regulation Goes Into Effect December 13

A new food labeling regulation, which revamps the entire EU regulatory framework on food information, including labeling, starts to apply from this Saturday, 13 December 2014. Regulation 1169/2011 on the provision of food information to consumers (FIC Regulation) consolidates a number of EU food laws and establishes some new principles to provide better consumer protection … Continue Reading

The German Supreme Administrative Court Confirms That E-Cigarettes Are Not Medicines Or Medical Devices

On 20 November 2014 the German Supreme Administrative Court (Bundesverwaltungsgericht, “BVerwG”) confirmed that nicotine-containing liquids that are vaporised and inhaled via e-cigarettes are not medicines and therefore e-cigarettes are not medical devices.… Continue Reading

E-Health Take Note: Standards Published For Personal Data In The Cloud

The health sector handles substantial quantities of personal information, including information that is deemed to be “sensitive” under European data protection regimes.  For that reason, health care providers sometimes question their ability to take advantage of increasingly popular e-health cloud services.  While EU lawmakers are contemplating a “European Privacy Seal” – which could, if done … Continue Reading

EU Court Of Justice Further Clarifies Definition Of Medicinal Products – And Raises New Questions

On 10 July 2014, the Court of Justice of the European Union (CJEU) gave its judgment in a case involving “legal highs” that a substance which only influences physiological functions without any beneficial effects on human health, shall not be considered as a medicinal product within the meaning of Article 1(2)(b) of Directive 2001/83/EC (decision … Continue Reading

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

Johnson & Johnson / Novartis: Another Pay-For-Delay Down for the European Commission

On 11 December 2013, the European Commission (“Commission”) sanctioned pharmaceutical firms Johnson & Johnson and Novartis with fines totaling EUR 16.3 million over a co-promotion agreement which allegedly delayed the sale of generic versions of pain killer Fentanyl in the Netherlands. Johnson & Johnson initially developed and commercialised Fentanyl in the 1960s.  In the Netherlands, … Continue Reading

The CDA – Five Practical Considerations

The Confidential Disclosure Agreement (“CDA”) is widely used in the Life Sciences Sector, and provides protection for a key asset – a party’s confidential information and trade secrets.  This post does not propose to go through the various possible provisions of a CDA or their negotiation, but instead sets out five practical considerations to take into … 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
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