Last week’s round-up, 19-23 August 2019

By Tessa Fiorini-Cohen and Marthese Mifsud


Administrative Law Overview | RAPS

23 Aug 2019 

A comprehensive overview of the United States’ federal administrative processes as related to regulatory affairs has recently become available on RAPS.

The publication explains the Federal Register, Code of Federal Regulations, and the Administrative Procedures Act through which stakeholders can comment on proposed rules. The Federal Register is the government’s daily legal newspaper that publishes rules, proposed rules and notices by federal agencies, including the FDA. Regulations are eventually codified as final rules in the Code of Federal Regulations.

The public and stakeholders can have their say on regulations through the comments process when a proposed rule is published in the Federal Register, or through an alternative route: petition submissions. Through these, the submitter can petition the FDA to issue, change or cancel a regulation. The article covers best practice for both:


10 facts on how mosquitoes pose a threat to half of the world

22 Aug 2019

Mosquitoes kill over one million people every year, and up to a billion additional people could be exposed to mosquito-carried viruses by 2080 thanks to global heating.

World Mosquito day fell last Tuesday, commemorating the 1897 discovery that female mosquitoes transmit malaria between humans. The World Health Organisation used the occasion to warn that progress against malaria is stalling. Reuters also released a 10-point list, showing how the tiny insect has affected humans and how related risks can be mitigated:


USP Consults on Impurity Reporting Threshold Changes | RAPS

21 Aug 2019

The United States Pharmacopeia and National Formulary (USP-NF) has launched a public consultation on organic impurity reporting thresholds.

Reacting to an FDA request, the USP-NF has proposed to stop including impurity reporting thresholds in its drug substance and drug product monographs. The underlying reason is that the use of reporting thresholds may reduce the possibility of identification and reporting of non-specified toxic impurities.

This change would apply to currently proposed monographs and those drafted in the future, but existing monographs would only be updated once revised for other reasons. Stakeholders have until 20th November to submit related comments:


EMA/FDA analysis shows high degree of alignment in marketing application decisions between EU and US

20 Aug 2019

Marketing authorisation decisions taken by the EMA and FDA are aligned in more than 90% of new medicine applications. This figure was obtained through a comparison of 107 new medicine applications submitted to the two agencies between 2014 and 2016. Where the agencies differed in their decisions, this was most commonly due to divergent conclusions about efficacy, or due to submission of different clinical data by the applicant as a result of spacing out of the two applications. The full study is available via open access in the journal Clinical Pharmacology and Therapeutics:


EU Regulatory Roundup: UK Confirms US Sites Can Batch Test Drugs in Event of a No-Deal Brexit

19 Aug 2019

The UK has confirmed that it will still accept batch-testing from the United States in the event of a no-deal Brexit. The exceptions to this are vaccines, advanced therapy medicinal products and medicinal products derived from human blood or plasma. In other regulatory news, the UK’s National Institute of Health and Care Excellence (NICE), has recommended against the use of cannabis medicines in many situations. Its current position is that physicians should consider the cannabinoid nabilone as an add-on treatment for chemotherapy-induced nausea and vomiting, but otherwise avoid the use of cannabis-based medicines. NICE is accepting feedback on these draft recommendations until 5 September. Germany’s BfArM has announced that it will accept clinical trial applications via the CESP platform, whereas Romania’s NAMMDR has upped its marketing authorisation fee by a five-fold margin.Their new fee is 5000 euros:


Image: A female Aedes albopictus mosquito, Public Domain Mark 1.0

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