MHRA Blog post by Tracy Moore, 8th August.
Further guidance note on the regulation of medicines, medical devices and clinical trials if there’s no Brexit deal - Updated 8 August 2019
Dr Ian Hudson, CEO, Medicines and Healthcare products Regulatory Agency (MHRA) spoke with Viveka Roychowdhury on how the Agency is working with pharmaceutical companies to increase compliance with Good Manufacturing Practices (GMP) as well as preparing for Brexit and beyond. Read the full article.
Detailed guidance on advertising and promoting medicines - updated 12th August 2019.
The first edition of the EMA's 'What’s new in Pharmacovigilance? QPPV UPDATE' is available.
New MHRA Blog Post on eHRs: as you will be aware, in the UK there is a national NHS initiative to replace patients’ paper medical records with electronic health records (EHRs). Although a national initiative, trusts are implementing this locally with different service providers. At several trusts this consists of scanning all written records into the EHR and destroying original source documents (both historic records and current visits).
BP and USP MoU formalise partnership to strengthen quality of medicines and public health
The European Medicines Agency (EMA) has published a draft guideline on quality requirements for combinations of medicinal products and medical devices (so-called Drug Device Combinations - DDCs).
Supporting medicine developers in generating quality data packages in early access approaches (PRIME and breakthrough therapies): workshop report published
The OECD recently released document 20 in the GLP series: Guidance Document for Receiving Authorities on the Review of the GLP Status of Non-Clinical Safety Studies.