About Ben Smith

Ben is a pharmaceutical industry professional with more than 5 years of international regulatory affairs experience in licensed pharmaceuticals and investigational medicinal products.

International Recognition Procedure

2024-01-18T15:19:35+00:00September 5th, 2023|

From 1st January 2024, the MHRA will be introducing new International Recognition Procedures (IRP) for marketing authorisations in the UK for both new and generic medicines. These recognition procedures will absorb the existing EU recognition procedures; the EC Decision Reliance Procedure (ECDRP) and the Mutual Recognition/Decentralised Reliance Procedure (MRDCRP), as well as introduce new recognition procedures for medicines authorised by the MHRA’s specified Reference Regulators (RR).

Nutraceuticals, a new product sector for the UK?

2024-01-16T15:44:40+00:00July 9th, 2021|

Last month, the Taskforce on Innovation, Growth and Regulatory Reform (TIGRR) report was published, giving its recommendations to the Prime Minister on how the UK can reshape its approach to regulation and seize new opportunities from Brexit.

A year at JensonR+

2023-10-10T11:54:25+01:00October 13th, 2020|

It's been a year since Ben Smith, our Regulatory Officer joined the JensonR+ team and we thought it would be interesting to have a catch up with him and see how his work life has evolved over the last 12 months.

CAP Grandfathering

2024-01-15T11:32:50+00:00October 1st, 2020|

BREXIT will affect the pharmaceutically industry greatly and with an exit date of 31/12/2020 it is important that you are aware of all the changes that will take place - there are a lot of important dates and pressure points that you need to be aware of.

EMA soon to publish updated guidance on Nitrosamine Impurities

2024-01-15T11:29:37+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

2024-01-15T11:26:27+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’ [...]

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