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Medical Devices: Deal Reached on New EU Rules

On Wednesday 25 May the EU institutions reached agreement on the draft texts for the revised Medical Devices Regulation and In Vitro Diagnostics Regulation, which will together replace the existing three Directives regulating devices, active implantable devices and in vitro diagnostics. The agreed two draft regulations are expected to achieve a twofold aim: making sure […]

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Data Protection on Blue Puzzle on White Background.

Reform of EU Data Protection Rules

The EU Data Protection legislation has been reformed. On 15 December 2015, the European Parliament, the Council and the Commission reached agreement on the new data protection rules, establishing a modern and harmonised data protection framework across the EU. The European Parliament’s Civil Liberties committee and the Permanent Representatives Committee (Coreper) of the Council then […]

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FDA Releases Guidance on 3D Printers for Medical Applications

FDA has developed this draft guidance to provide FDA’s initial thinking on technical considerations specific to devices using additive manufacturing, the broad category of manufacturing encompassing 3-dimensional (3D) printing. Additive manufacturing (AM) is a process that builds an object by iteratively building 2-dimensional (2D) layers and joining each to the layer below, allowing device manufacturers […]

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The Use of Patient-Reported Outcome (PRO) Measures in Oncology Studies

The importance of the patient’s point of view on their health status is fully acknowledged and such information may be used in drawing regulatory conclusions regarding treatment effects, in the benefit risk balance assessment or as specific therapeutic claims in Section 5.1 of the SmPC (Secord et al., 2015, CHMP Reflection paper on the regulatory […]

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Implementation of the Hong Kong Electronic Health Record Sharing System

The Electronic Health Record Sharing System Ordinance came into effect on 2 December 2015. The Ordinance provides the legal framework for public and private hospitals and other healthcare providers to collect, share and keep patient’s electronic health record (eHR) through the Electronic Health Record Sharing System (the eHRS System) upon obtaining the informed consent of […]

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Canada – Threading the Biosimilar Needle

Biosimilars, otherwise known as subsequent entry biologics or “SEBs” in Canada, are a rapidly emerging trend in healthcare. There is a common misconception that biosimilars are “generic” biologic medications. In reality, biosimilars and traditional generic pharmaceuticals are significantly different, principally due to the distinct nature and complexity of the molecular structure of biologics. Biosimilars present […]

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Drug Makers to Prepare for Pharmacovigilance Reforms in Russia and Other EAEU Countries

Drug companies operating in Russia and other Eurasian Economic Union (“EAEU”) countries are being advised to prepare for the new obligations and liabilities that an impending new regulation on pharmacovigilance in the EAEU might introduce for them. The new regulation, which will bring the EAEU more in line with the EU rules on pharmacovigilance, is currently […]

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Italy: Drugs, Competition, Bioequivalence and Therapeutic Equivalence

The Italian Supreme Administrative Court has just released an articulated judgment (n. 1306 of April 1, 2016) focused on the notion of “therapeutic equivalence” of pharmaceutical products, a concept which, as specified by the administrative judge, is conceptually and legally distinct from that of “equivalent drug” and “biosimilar drug”. ”The origin of the notion of […]

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EMA Begins EudraVigilance Training Courses

The European Medicines Agency (EMA) has begun running a series of modular training courses to support stakeholders in using EudraVigilance, the centralized database for managing information on suspected adverse reactions reported with medicines authorised in the European Economic Area (EEA). Two sets training courses are available. The first set of three-day training courses is targeted […]

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