– soon in a pharmacy near you? Generic competition is an effective way to push down drug prices, but it has not worked equally well for biosimilars. Biosimilars require more time to gain market share compared to generics, and new biosimilars do not always lead to lower prices. In a report to the Swedish government … Continue reading Interchangeable biological medicines
Kategori: Blog
”Do we have the right balance between risk and patient benefit?”
Does the introduction of MDR and IVDR mean that we risk losing important medical technology innovations? Do the tightened rules make the certification process so complex that start-up companies simply do not participate and give up, with the result that important innovations that can improve care never reach the market? What can we do in … Continue reading ”Do we have the right balance between risk and patient benefit?”
”The situation is not satisfactory”
One of the more important aims of the EU pharmaceutical legislation is to ensure access to affordable medicines to all patients in the region. A new product, for example to treat cancer, should be available for all EU patients, including those in the smaller member states. The reality, however, is that many of the new … Continue reading ”The situation is not satisfactory”
Unclear proposal from the EU Commission on how to solve the MDR challenges
Even before the EU regulation on medical devices (MDR) came into force, medical technology companies and doctors were concerned that it would endanger the availability of medical devices in the EU. Unfortunately, the fears have come true. Above all, notified bodies have a limited capacity following the stricter requirements since the MDR came into force. … Continue reading Unclear proposal from the EU Commission on how to solve the MDR challenges
Potential step change – EU regulators get to play with data
EMA has launched a new pilot to assess whether the analysis of ‘raw data’ by regulatory authorities improves the evaluation of marketing approval for new medicines. The pilot will run for 2 years starting in September. Still, regulatory decisions within EU are based on the assessment of applicant’s own analyses, which in turn must be thoroughly … Continue reading Potential step change – EU regulators get to play with data
New incentives for orphan products on its way
In the late 90-ies, there was a concern among regulators and health care professionals that too few products targeting the unmet need in rare diseases were put on the market. Patients had very few treatment alternatives and if any, those were often off-label treatment with limited documentation to support their efficacy and safety. Something has … Continue reading New incentives for orphan products on its way
IVD manufacturer – use the progressive roll-out of IVDR in a smart way
The countdown has started. On 26th of May the In Vitro Diagnostic Regulation, also known as IVDR, is entering into force. The aim of the regulation is to establish a robust, transparent, predictable, and sustainable regulatory framework for in vitro diagnostic devices (IVDs), which ensures a high level of safety and health whilst supporting innovation. … Continue reading IVD manufacturer – use the progressive roll-out of IVDR in a smart way
Finally time for revision of the EU pharma legislation
It is exciting times ahead for those interested in the future regulation of pharmaceuticals. It should be a priority not only for regulatory nerds like myself. Much have happened since the last update of the EU legislation. New technology has led to increase of the understanding of disease mechanisms and design of “targeted therapies” that … Continue reading Finally time for revision of the EU pharma legislation
Repurposing as a golden ticket to approval?
“Drug repurposing” is finding new therapeutic use of substances no longer protected by patent or regulatory exclusivity. This route is actively pursued by parts of the pharmaceutical industry. But what if there is a high unmet medical need and no commercial interest? This is something that has concerned the European Commission in Brussels. Let us … Continue reading Repurposing as a golden ticket to approval?
Big data evidence generation drives change in EU regulatory system
Rapid developments in technology have led to the possibility for generation and analysis of vast volumes of data. Will the availability of big data lead to fundamental changes to the regulatory system? The question was addressed by the HMA/EMA task force on Big Data with the aim to “…inform strategic decision-making and planning and to … Continue reading Big data evidence generation drives change in EU regulatory system