Last week’s round-up, 23 – 27 March 2020

By Stephanie Allampalli, Tessa Fiorini-Cohen and Marthese Mifsud   EU-China Working Group to Address API Manufacturing Concerns 27 March 2020 China’s National Medical Products Administration (NMPA) will be working with the European Commission’s DG Sante, the European Medicines Agency (EMA) and others to conduct a gap analysis between the Chinese and EU regulatory systems for […]

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Last week’s round-up, 11 -15 November 2019

By Tessa Fiorini-Cohen and Marthese Mifsud   ICH Survey Shows Wide Adoption of Guidelines Among Regulators, Industry 15 November 2019 A recent survey shows wide adoption of ICH guidelines across regulators and industry. The survey collected responses from 32 pharmaceutical companies who provided information on 15 regulatory authorities, which ranged between ICH founding members, newcomers […]

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Last week’s round-up, 14 – 18 October 2019

By Tessa Fiorini-Cohen and Marthese Mifsud   Updated product-specific bioequivalence guidance 18 Oct 2019 The EMA has finalised product-specific bioequivalence guidance for seven drug substances. The substances affected are alectinib, apixaban, cabozantinib, colchicine, ezetimibe, gefitinib, and palbociclib. All guidances were adopted on 15 October 2019. Those for apixaban and gefitinib will become legally effective on […]

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Last week’s round-up, 23-27 September 2019

By Tessa Fiorini-Cohen and Marthese Mifsud   EMA advises companies on steps to take to avoid nitrosamines in human medicines 27 Sep 2019 All EU marketing authorisation holders of medicinal products containing chemically synthesized APIs need to review their medicines for the possible presence of nitrosamines within the next six months. The EMA is sending a notice to […]

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Last week’s round-up, 02-06 September 2019

By Tessa Fiorini-Cohen and Marthese Mifsud   Has AI Discovered a Drug Now? Guess. 06 Sep 2019 The media is abuzz with reports that an artificial intelligence model has designed a drug in 21 days, however an opinion piece in Science Translational Medicine takes a more nuanced view. The software model is acronymed GENTRL (generative tensorial reinforcement learning), […]

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Congratulations to our colleague Tessa Fiorini-Cohen on graduating with Distinction

Congratulations to our colleague Tessa Fiorini-Cohen, Regulatory Affairs Consultant with Real Generics who recently completed a MSc. in Science Communication and Public Engagement (University of Edinburgh) with Distinction. The MSc. in Science Communication and Public Engagement delves into a variety of science communication and public engagement methodologies and issues. Topics covered include science policy, science […]

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Reference medicinal products in the European Economic Area.

Reference medicinal products

Choosing a reference product for an abridged submission in Europe may not be straightforward. We have created a presentation that will guide you through the basics. You can find the Haiku Deck presentation here.   Real Generics Ltd is a member of the Real Regulatory Group. The partner company, Real Regulatory Ltd, is a consultancy […]

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Elemental impurities

Real Generics’ Regulatory News Digest For Generics – 10 August 2015

Draft ICH Guidelines for Consultation Mutagenic impurities ICH has released a draft addendum to ICH Guideline M7 on Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk. The addendum summarises known mutagenic impurities commonly found or used in drug synthesis (e.g. aniline, dimethyl sulfate, ethyl chloride, hydroxylamine), providing acceptable […]

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Real Generics’ Regulatory News Digest For Generics – 20 July 2015

Reflection paper on the use of cocrystals of active substances in medicinal products EMA has adopted a reflection paper (EMA/CHMP/CVMP/QWP/284008/2015) on cocrystals. Cocrystals are homogeneous crystalline structures consisting of two or more components in a definite stoichiometric ratio. Cocrystals (which also include solvates) differ from salts in being assembled through weaker interactions than ionic bonds, […]

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Real Generics Limited

Real Generics established in April 2015: Paddy Creed and Karen Real have established a new sister company to Real Regulatory Limited (RRL). The new company is called “Real Generics Limited” (RGL). It is driven and managed by Michelle Gafa as Managing Consultant. The purpose of the company is to provide regulatory support for generic type […]

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