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’ [...]

Making sense of the regulatory landscape in the UK and Europe

2024-01-15T11:15:01+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

2024-01-15T10:39:50+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 [...]

Confirmed: Date of MDR application put back by one year

2024-01-15T10:10:11+00:00April 28th, 2020|

Confirmed: Date of MDR application put back by one year Following our post on the 26th March regarding the European Council (EC) proposal to delay the Medical Devices Regulation (MDR - 2017/745) due to COVID-19, the proposal has been overwhelmingly backed by the European Parliament and was published in the Official Journal on [...]

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

2024-01-15T10:07:43+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 [...]

Nitrosamines: Considerations for Marketing Authorisation Holders

2024-01-15T09:49:34+00:00December 19th, 2019|

Nitrosamines: Considerations for Marketing Authorisation Holders Following a press release from the EMA on 26 Sep 2019, all marketing authorisation holders (MAHs) for human medicines containing chemically synthesised active substances must review their products for the possible presence of the carcinogenic class of compounds called nitrosamines. But where [...]

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