Regulators in Europe are beginning to give safety readouts from global experiences with vaccines against COVID-19, while the United Kingdom has issued a report delineating its multi-pronged safety surveillance approach.   The European Medicines Agency’s safety committee met at the end of January to review data from clinical use of the COVID-19 messenger RNA (mRNA) vaccine co-developed by Moderna and the US National Institutes of Health.   Following a 28 January mee...

As the first week of the new year winds down, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has approved a third vaccine against COVID-19. On Friday, MHRA announced its regulatory approval of the messenger RNA (mRNA) vaccine jointly developed by Moderna and the US National Institutes of Health.   “Having a third COVID-19 vaccine approved for supply following a robust and thorough assessment of all the available data is an important goal to have ac...

After years of painstaking negotiations, the UK parted ways with the EU on 1 January after an 11-month transition period with a 1,200-plus page trade deal in hand, narrowly avoiding a no-deal scenario.   The trade deal, which was reached on 24 December, avoids tariffs and quotas on goods traded between the EU and UK and sets forth some provisions for cooperation and alignment on a range of issues from transportation to environmental protection but avoids major topics...

Editor’s note: This article was updated 04 January 2020 to include new information about EMA's review of the Oxford-AstraZeneca COVID-19 vaccine.   The United Kingdom has followed the recommendation of its Medicines and Healthcare products Regulatory Agency (MHRA) to issue temporary authorization for the vaccine against COVID-19 co-developed by Oxford University and AstraZeneca. The UK’s authorization is the first for the vaccine.   The authorization for temporar...

The US Food and Drug Administration (FDA) on Monday announced it will pilot a new program it hopes will spur the development of novel drug development tools (DDTs) that do not fit within the agency’s existing DDT qualification programs.   The qualification process for DDTs was revamped under the 21 st Century Cures Act and FDA currently offers specific qualification programs for biomarkers, clinical outcome assessments (COAs) and animal models for use under the Anim...

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has issued a draft guidance on the use of real-world evidence in clinical trials. The guidance, which remains open for consultation for 6 weeks from its 30 October publication date, is intended for sponsors planning clinical research in support of regulatory decisions.   MHRA notes that real-world evidence (RWE) may help investigators get at how a treatment will really work when it is in community use ...

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) on Thursday issued post-transition guidance on orphan medicines designations and incentives, as well as guidance on supplying medicines from Great Britain to Northern Ireland.   The guidances are the latest in a suite of post-transition guidance from the agency as it prepares for the Brexit transition period to expire at the end of the year. (RELATED: MHRA posts suite of post-transition guidances , ...

Trade bodies representing the UK and European Union pharmaceutical industries have urged Brexit negotiators to act now to prevent disruption to the supply of medicines. The joint statement warns failing to form a mutual recognition agreement to soften a hard Brexit could cost both sides billions and delay the supply of medicines by up to six weeks.   The latest round of negotiations about the post-Brexit relationship between the UK and EU is due to end on Friday. If su...

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) this week issued guidance detailing post-transition pharmacovigilance procedures and requirements for having a qualified person responsible for pharmacovigilance (QPPV) and a pharmacovigilance system master file (PSMF) for UK authorized products.   Pharmacovigilance   MHRA says it “will retain responsibility for pharmacovigilance across the UK from 1 January 2021,” but notes that there will be di...

In its suite of post-transition guidances released Tuesday, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) issued a dozen documents explaining how medicines licensure will work after the Brexit transition period expires on 1 January 2021.   The guidance, which largely mirrors the “no deal” scenario laid out in now-withdrawn guidance issued last year, explains a range of issues from converting centrally authorized products (CAPs) to UK marketing au...

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) on Tuesday released more than two dozen guidance documents explaining how drugs, medical devices, clinical trials and more will be regulated after the Brexit transition period expires on 1 January 2021.   Clinical trials   Two guidances related to clinical trials explain requirements for the registration of clinical trials for investigational medicinal products and the submission of substantial ...

The US Food and Drug Administration (FDA) on Monday announced it will not begin collecting drug manufacturing volume data next month as required by the Coronavirus Aid, Relief, and Economic Security Act (CARES Act).   Section 3112 of the CARES Act establishes new reporting requirements for drug manufacturers intended to improve the response to drug shortages, including expanding shortage reporting requirements for life-saving drugs to include drugs that are “critical...