EU: Revision 3 of the ENCePP Guide on Methodological Standards in Pharmacoepidemiology Published (14 July 2014)

The Guide on Methodological Standards in Pharmacoepidemiology offers a single web resource for methodological English language guidance in pharmacoepidemiology. For each topic covered, direct electronic access is given to internationally agreed recommendations, and key points from important guidelines, published articles and textbooks are highlighted. Where relevant, gaps in existing guidance are addressed with what ENCePP […]

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Ireland – The Irish Medicines Board (IMB) is now the Health Products Regulatory Authority (HPRA) (01/07/2014)

On 1 July 2014, the Irish Medicines Board (IMB) changed its name to the Health Products Regulatory Authority (HPRA). Established in 1996, the IMB name has served us well. However, over the last 18 years our regulatory remit has expanded to include other health products as well as a number of health related functions. In addition […]

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Impact of New EU Clinical Trials Regulation on UK Approval System (17/06/2014)

On 27 May 2014, the Clinical Trials Regulation was published in the Official Journal of the EU (OJEU). The regulation, which will replace the existing EU Clinical Trials Directive, will streamline the authorisation process and harmonise requirements for clinical trials in Europe. Applicants will now submit a single application for a clinical trial, regardless of the number […]

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EU: EMA Releases Best Practice Guidance on Parallel Scientific Advice with Health-Technology-Assessment Bodies (08/05/2014)

Guidance to facilitate early dialogue between regulators, health-technology-assessment bodies and medicines developers The European Medicines Agency (EMA) has published today for public consultation best practice guidance for pilot parallel scientific advice procedures involving the EMA and health-technology-assessment (HTA) bodies. The document is a key outcome of the EMA-HTA workshop on parallel scientific advice, which took […]

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UK: MHRA Guidance Note 14 – The Supply of Unlicensed Medicinal Products (“Specials”) (07/05/2014)

MHRA guidance on the supply of unlicensed medicinal products (‘specials’) better known as MHRA Guidance Note 14 has been updated. This guidance has been updated following the consolidation of medicines legislation into the Human Medicines Regulations 2012 and takes into account the outcomes of relevant European court cases. This guidance note provides advice on the […]

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EU: Revision 3 of EMA Guideline on Good Pharmacovigilance Practices (GVP): Annex I – Definitions Updated on 25 April 2014

Revision 3 of EMA Guideline on Good Pharmacovigilance Practices (GVP): Annex I – Definitions was updated on the 25 April 2014 Revision 3 includes the following: Amendments of definitions of Missing information (including its explanatory note) and Risk minimisation activity in accordance with revision 1 of GVP Module V

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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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