The MHRA is planning to relocate near the current EMA headquarters in Canary Wharf in East London. The move will take place around the middle of 2018, shortly before the EMA
31 Jul, 2017
31 Jul, 2017
In keeping with the recent spate of MHRA campaigns to improve adverse event reporting of drug reactions by patients and healthcare professionals, it seems other health
31 Jul, 2017
KEYTRUDA: Merck have announced their anti-PD-1 therapy for the treatment of certain patients with locally advanced or metastatic urothelial carcinoma has been recommended for
31 Jul, 2017
Two signals were detected from EU Spontaneous Reporting Systems • Ritonavir NORVIR, lopinavir, ritonavir – KALETRA; levothyroxine: a signal of interaction possibly
31 Jul, 2017
During its July meeting, the European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) concluded two referrals and continued its evaluation of six
The EMA published a press release on 16 June 2017, announcing the entry of force of the Clinical Trial Regulation has been delayed until 2019. At the EMA management board
Legislation in Poland reducing women’s access to the morning after pill has been widely condemned as an affront to European values. The new law requires the contraceptive to
10 Jul, 2017
In December 2016, the MHRA classified cannabis oil as a medicine, which contains cannabidiol (CBD) but does not contain tetrahydrocannabinol (THC) which induces a ‘high’ or
10 Jul, 2017
Adverse drug reaction (ADR) reporting relies on HCPs and patients reporting these events in order to make medications safe. However, the MHRA is still finding that ADRs are
A new study published in the international journal CNS Drugs this month has identified the need for urgent updated guidance for the anti-psychotic drug clozapine, used to
Recent Posts
- EU QPPV/UK QPPV and local requirements: is this now a global role?
- Essjay Newsletter – October 2019
- Are your UK PV operations Brexit ready?
- New Approvals and Launches June
- Submitting Risk Management Plans on the New EU template: 3 tips
- How to Manage Compliant Reference Safety Information (RSI) and maintain compliance