A new “smart pill” bottle which prompts patients to take their medications on time and notifies doctors when it has been dispensed, has shown 100% reliability in improving medication adherence. Read more “New “smart pill” technology shows 100% success rate”
Year: 2019
Did you know the FDA have proposed a novel excipient evaluation programme?
The US Food and Drug Administration (FDA) are debating the creation of a pilot programme to evaluate the toxicology and quality of novel excipients. Read more “Did you know the FDA have proposed a novel excipient evaluation programme?”
Are you aware that the CMDh have released a useful best practice guide on multilingual packaging?
The Co-ordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh) have published a best practice guide for marketing authorisation applicants, covering multilingual packaging requirements for mutual recognition (MR) and decentralised procedure (DCP) products. Read more “Are you aware that the CMDh have released a useful best practice guide on multilingual packaging?”
Regulis wins TOPRA Regulatory Support Award 2019!
We are thrilled to announce that our medical devices team collected the Support award at TOPRA’s 10th Awards for Regulatory Excellence. Read more “Regulis wins TOPRA Regulatory Support Award 2019!”
How is the EMA helping communities make a difference to the global response to HIV and AIDS?
The European Medicines Agency (EMA) is contributing to the global response to HIV and AIDS through scientific evaluation, supervision and safety monitoring of medicines, and active patient engagement. Read more “How is the EMA helping communities make a difference to the global response to HIV and AIDS?”
An overview of the opportunities and challenges posed by bringing clinical trials into the domain of big data
The Clinical Trial and Imaging Subgroup of the European Medicines Agency (EMA) has released a report on the issues associated with the combination of data from different clinical trials into large datasets. Read more “An overview of the opportunities and challenges posed by bringing clinical trials into the domain of big data”
How does the EMA plan to improve the quality of pharmacovigilance reporting systems for ADRs?
The regulatory drive to increase the amount of data and improve the quality of pharmacovigilance (PhV) reporting systems is key to maintaining the databases at the forefront of signal detection. Read more “How does the EMA plan to improve the quality of pharmacovigilance reporting systems for ADRs?”
How will Canada’s new Medical Devices Directorate help to tackle the growing medical device industry?
Health Canada recently announced the creation of a new Medical Devices Directorate (MDD), to address the challenges and opportunities relating to the ever-changing landscape of the medical device industry. Read more “How will Canada’s new Medical Devices Directorate help to tackle the growing medical device industry?”
The need for cross-sectoral, global cooperation to fight antimicrobial resistance
The statement emphasises the role of medicines regulators in efficiently bringing safe, effective and high quality antimicrobial products to the market, as well as minimising the regulatory barriers which can prevent access to essential treatments. Read more “The need for cross-sectoral, global cooperation to fight antimicrobial resistance”
Introducing a new form for drug safety signals regarding human medicinal products
The Swiss Agency of Therapeutic Products (Swissmedic) has created a new Signal Notification Form as part of its plan to make safety data collection more efficient. Read more “Introducing a new form for drug safety signals regarding human medicinal products”