Last week’s round-up, 30 September – 04 October 2019

By Tessa Fiorini-Cohen and Marthese Mifsud   Delays in treatment of requests for revision and renewal of CEPs 03 Oct 2019 The EDQM has communicated that it is currently experiencing some difficulty in achieving the assessment times for revisions and renewals of CEP applications. The delay is currently about 5 weeks and the EDQM has […]

Read More

Last week’s round-up, 09-13 September 2019

By Tessa Fiorini-Cohen and Marthese Mifsud   Stella Kyriakides has been named the new European Commissioner for Health 13 Sep 2019 Kyriakides will preside over the implementation of the EU Medical Devices Regulation and the In Vitro Diagnostics Regulation. Ursula von der Leyen has specifically requested that the new commissioner focuses on effective implementation of this new regulatory […]

Read More

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), […]

Read More

Last week’s round-up, 12-16 August 2019

By Tessa Fiorini-Cohen and Marthese Mifsud   MHRA’s no-deal Brexit guidance 12 Aug 2019 Updates to the MHRA’s no-deal Brexit guidance have indicated a shift in the government’s willingness to leave without a deal. The guidances typically started with the following statement, which has now been dropped: “Leaving the EU with a deal remains the […]

Read More
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 […]

Read More