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 government’s top priority. This has not changed. However, a responsible government must plan for every eventuality, including a no-deal scenario.” Other notable changes involve conversion of Parallel Distribution Notices (PDNs) to UK Parallel Import Licenses (PILs) – under the revised guidance, the MHRA is giving companies three weeks after the UK leaves the EU to submit a list of PDNs that will need converting. Failure to submit in time will result in the need for a new application for a parallel import license. In other regulatory news, the EMA has given manufacturers of liposomal medicines until the end of September to change the names of their products. This is to reduce the chance of medication errors arising from confusion between liposomal and non-liposomal medicines:


Early access schemes within the EU and US

13 Aug 2019

Developments can be expected in relation to early access schemes within the EU and US.

These fast-track the approval of medicines which address unmet medical needs, but applicants currently face development and submission challenges due to accelerated timelines and novel situations. With this in mind, the EMA and FDA recently held a joint workshop with stakeholders to identify where the main challenges lie and what further support can be given. Much has been proposed for further work, and we’ve outlined the main discussions and conclusions here:


UK to make it easier to employ migrant scientists after Brexit

14 Aug 2019

UK Prime Minister, Boris Johnson, plans to make it easier for companies to employ migrant scientists after Brexit.

His plan is to “turn the U.K. into a kind of supercharged magnet, drawing scientists like iron filings from around the world”. Currently under discussion is lifting of the current cap on the number of visas available to exceptional talents, granting the dependents of migrant scientists full access to the labor market, and establishing an accelerated path to settlement:


‘What’s new in Pharmacovigilance?’

16 Aug 2019

The latest issue of the EMA’s newsletter, ‘What’s new in Pharmacovigilance?’ has been released.

The newsletter is published four times a year, and updates qualified persons for pharmacovigilance on guidance, regulations, publications and activities. Within the August 2019 issue, there is a review of EudraVigilance in 2018, as well as the EMA’s work on drug-event pair screening and vaccine benefit-risk monitoring.

The newsletter informs readers that the EU’s signal management work-sharing list has been updated due to reallocation of substances to different Member States. It also includes various summaries of pharmacovigilance-related publications, including the HMA/EMA Joint Big Data Task Force summary report and the first collaborative interagency regulatory study published, which deals with the impact of regulatory measures on prescribing of codeine for pain in children:


Image: Brexit, CC0 Public Domain

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