About Ben Smith

Ben joined JensonR+ Ltd in October 2019 as regulatory officer, to support our clients with a wide range of regulatory activities from eCTD dossier creation to advice on borderline medicines.

150 Days to the End of the Transition Period: A Focus on Centrally Authorised Products

2021-01-12T13:46:14+00:00August 3rd, 2020|

150 Days to the End of the Transition Period: A Focus on Centrally Authorised Products Today marks 150 days until the end of the UK-EU transition period; on the 1st January 2021 the UK will no longer be in the EU single market and customs union. Following on from our post about the possible [...]

EMA soon to publish updated guidance on Nitrosamine Impurities

2021-01-12T13:46:21+00:00July 20th, 2020|

EMA soon to publish updated guidance on Nitrosamine Impurities The EMA’s human medicines committee (CHMP) has now issued an opinion regarding the maximum limits of  nitrosamines in medicines and the measures required by pharmaceutical companies to reduce the presence of these carcinogenic impurities. As captured in our 2019 posts regarding nitrosamines and the considerations [...]

Deadline Looms for the Safe Labelling of Excipients in Medicines

2021-01-12T13:46:35+00:00July 10th, 2020|

Deadline Looms for the Safe Labelling of Excipients in Medicines In October 2017, the EMA and European Commission updated the annex to excipient guidelines for new safety advice of 15 excipients and the three-year timeline to implement the change is nearly over. Excipients are considered to be the ‘inactive’ [...]

Making sense of the regulatory landscape in the UK and Europe

2021-01-12T13:46:59+00:00June 23rd, 2020|

Making sense of the regulatory landscape in the UK and Europe This year marks the 10-year anniversary since eCTD became mandatory for all submissions to the EMA for Centrally Authorised Products, meaning all these products have eCTDs hosted by the EMA. After the transition period on the 31st December 2020, the MHRA will [...]

MHRA Regulatory Flexibilities during the COVID-19 Pandemic

2021-01-12T13:47:21+00:00June 4th, 2020|

MHRA Regulatory Flexibilities during the COVID-19 Pandemic In the wake of the on-going fallout from the COVID-19 pandemic, the MHRA has been active in taking steps to lessen the regulatory burden on companies working on issues central to the fight against COVID-19. Since the first publication of the guidance on [...]

EMA Provide Advice on Regulatory Expectations and Flexibility during the COVID-19 Pandemic

2020-05-12T12:39:40+00:00April 14th, 2020|

EMA Provide Advice on Regulatory Expectations and Flexibility during the COVID-19 Pandemic In the wake of the on-going COVID-19 pandemic, the EMA has published a Question and Answers document which provides guidance to stakeholders on the implemented adaptations to regulatory framework that have been put in place to address some of the unprecedented challenges [...]