EU: Regulation Regarding Post-Authorisation Efficacy Studies (10/04/2014)

Delegated Regulation EU/357/2014 of 3 February 2014  was published in the official journal on the 10 April 2014 and will become effective on the 30 April 2014 Delegated Regulation EU/357/2014 of 3 February 2014 Supplementing Directive 2001/83/EC of the European Parliament and of the Council and Regulation (EC) No 726/2004 of the European Parliament and […]

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CHCUK: 2014 Update to the NIS Considerations for Australia Now Available (05/04/2014)

Both the elearning module and the detailed country-specific report for the Australian NIS considerations have been updated.  So what’s changed? Medicines Australia Code of Conduct Guidelines Updated in Feb 2014 The Code of Conduct Guidelines now reflect and provide guidance on the 17th Edition of the Medicines Australia Code of Conduct, which became effective in […]

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CHCUK: 2014 Update to the NIS Considerations for France Now Available (23/03/2014)

Both the elearning module and the detailed country-specific report for the NIS considerations have been updated.  So what’s changed?   Updated Pharmacovigilance Legislation Decree No 2012-1244 of November 8, 2012 relating to the strengthening of the safety provisions of medicinal products for human use subject to market authorization and pharmacovigilance Transposes Directive 2010/84/EU into national […]

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UK: MHRA Guidance on Medical Device Stand-Alone Software – Including Apps (22/03/2014)

Many manufacturers, software developer, academics, clinicians and organisations are using software for both healthcare and social care needs. This guidance explains how this technology is regulated. It covers stand-alone software (also known as software as a medical device) but not software that is part of an existing medical device because this seen to be part […]

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EU: EMA Launches Pilot Early Access Program (20/03/2014)

The European Medicines Agency (EMA) is inviting companies to participate in its adaptive licensing pilot project. Companies who are interested in participating in the pilot are requested to submit ongoing medicine development programmes for consideration as prospective pilot cases. A framework to guide discussions of individual pilot studies has been published. The adaptive licensing approach, […]

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EU: European Medicines Agency Publishes First Summary of a Risk-Management Plan for a Medicine (19/03/2014)

The European Medicines Agency has published the first summary for the public of the risk-management plan (RMP) of a newly authorised medicine. This RMP summary, which concerns the medicine Neuraceq, describes what is known and not known about the medicine’s safety and states what measures will be taken to prevent or minimise its risks. The […]

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EU: Draft Regulation Regarding Post-Authorisation Efficacy Studies (17/03/2014)

EU pharmacovigilance legislation has recently undergone a major review that led to the adoption of new legislation in 2010, namely Directive 2010/84/EU and Regulation (EU) No 1235/2010. While the main focus of pharmacovigilance is the safety of the medicinal product, any new information received or new pharmacovigilance signals detected may have a potential impact on […]

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Russia: New Requirements for HCOs who Conduct Clinical Trials (10/03/2014)

On 14 February 2014, Rossiyskaya Gazeta, the official edition of the Russian Government, published Order No. 300n of the Russian Ministry of Healthcare dated 16 May 2013 “On approving the requirements for healthcare organisations which conduct clinical trials of medical products, and the procedure for establishing whether the healthcare organisations comply with these requirements” (the […]

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UK: Medical Records Appear to Have Been Wrongly Given to the Insurance Industry by the NHS (27/02/2014)

Source: BBC Online Details on hospital admissions from 1989 to 2010 were handed to the Institute and Faculty of Actuaries. The information was used to produce a report to help insurance firms price their products. The Health and Social Care Information Centre, which runs the database of records, said “greater scrutiny” should have been applied. […]

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Romania: New ARPIM HCP/HCO Disclosure Code (20/02/2014)

A new ARPIM Code on Disclosure of Transfers of Value from Pharmaceutical Companies to Healthcare Professionals (HCP) and Healthcare Organisations (HCO) was published in Dec 2013. The new code is applicable from 1st January 2015. Applicability of the Code The Code governs disclosures regarding certain interactions with HCPs and HCOs. It is intended that this […]

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