The US Food and Drug Administration (FDA) has published an updated version of the guidance on the use of ISO 10993-1 (Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process) to support medical devices application. Read more “New version of the FDA guidance on the use of ISO 10993-1”
News
Clinical data publication for COVID-19 related products
The European Medicines Agency (EMA) will require publication of clinical data for COVID-19 related medicines and vaccines in order to maximise the transparency of its regulatory activities. Read more “Clinical data publication for COVID-19 related products”
Ireland’s HPRA revise two guidances
Ireland’s Health Products Regulatory Authority (HPRA) has updated two guidances, on good distribution practices (GDP) and wholesaling of medicinal products for human use. Read more “Ireland’s HPRA revise two guidances”
New measures to support safe use of stimulant laxatives
The Medicines and Healthcare products Regulatory Agency (MHRA) have introduced pack size restrictions, age warnings and new safety warnings on labelling of over-the-counter (OTC) stimulant laxatives such as bisacodyl and senna. Read more “New measures to support safe use of stimulant laxatives”
New guidelines on the submission of periodic risk assessment reports to the NMPA
Medical device manufacturers seeking to market their products in China will be required to adhere to new guidelines in the risk assessments they submit to the National Medical Products Administration (NMPA). Read more “New guidelines on the submission of periodic risk assessment reports to the NMPA”
Post-transition guidance from the MHRA: Licensing
On 01 September 2020, the Medicines and Healthcare products Regulatory Agency (MHRA) laid out the future UK requirements regarding pharmaceutical and biological product licensing. Read more “Post-transition guidance from the MHRA: Licensing”
Post-transition guidance from the MHRA: Medical Devices
On 01 September 2020, the Medicines and Healthcare products Regulatory Agency (MHRA) laid out the future UK requirements on device certification, conformity marking and registration with the agency. Read more “Post-transition guidance from the MHRA: Medical Devices”
Post-transition guidance from the MHRA: Clinical Trials
On 01 September 2020, the Medicines and Healthcare products Regulatory Agency (MHRA) laid out the future UK requirements for registration of clinical trials for investigational medicinal products (IMP) and submission of substantial amendments. Read more “Post-transition guidance from the MHRA: Clinical Trials”
Post-transition guidance from the MHRA: Pharmacovigilance, QPPV and PSMF
On 01 September 2020, the Medicines and Healthcare products Regulatory Agency (MHRA) laid out the future UK requirements for submission of pharmacovigilance data at the end of the Brexit Transition period, as well as guidance on the qualified person responsible for pharmacovigilance (QPPV) and pharmacovigilance system master files (PSMF). Read more “Post-transition guidance from the MHRA: Pharmacovigilance, QPPV and PSMF”
European Commission strengthens preparedness for COVID-19 outbreaks
Immediate short term measure have been presented by the European Commission (EC) to enhance EU health preparedness for future COVID-19 outbreaks. Read more “European Commission strengthens preparedness for COVID-19 outbreaks”