Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.
PRAC Calls for HES Solutions to be Pulled From Market Over Kidney Injuries
Europe looks set to suspend the marketing authorizations for hydroxyethyl-starch (HES) solutions for infusion. The Pharmacovigilance Risk Assessment Committee (PRAC) recommended the suspension after a review found restrictions it imposed in 2013 had failed to stop the use of the drugs in patients at risk of kidney problems.
Doctors use HES solutions to expand blood volumes in patients who have suffered acute blood loss. In some patients, another class of medicines known as crystalloids are deemed sufficient to expand blood volumes. However, sometimes doctors decide they need to use colloids such as HES solutions.
The issue is HES solutions have been linked to kidney problems and death in some patients. These risks are most acute for patients suffering from sepsis and kidney injury. Recognition of the risk of giving HES solutions to these patients led PRAC to recommend placing restrictions on the populations eligible for treatment with the infusions in 2013. However, these restrictions have been ineffective.
Upon discovering that HES solutions are still being used in patients to whom they pose risks, PRAC considered imposing further limitations on the use of the products. However, the committee decided such actions were unlikely to be effective. As such, PRAC is recommending the European Medicines Agency (EMA) suspend the marketing authorizations of HES solutions.
That decision was underpinned by the knowledge that alternative treatments are available.
MHRA Rolls Out Online Portal to Streamline Medical Device Regulatory Services
The Medicines and Healthcare products Regulatory Agency (MHRA) is moving medical device firms over to new online accounts. MHRA is undertaking the transition as part of an attempt to streamline the services it provides to medical device companies by creating an online portal and other actions.
Officials at the United Kingdom regulatory agency began moving medical device companies over to the new accounts at the end of November and expect to complete the transition next month. After that, all medical device companies will have a single account through which all online interactions with MHRA take place.
All companies that use MHRA’s device registration and certificate of free sale services are moving to the new accounts. MHRA is providing companies affected by the changes with instructions and a go-live date. The companies will not need to re-register, but will need to take actions to update their accounts.
The rollout of the accounts is part of a broader attempt by MHRA to improve the service it provides to medical device companies. Following the switch, companies will be able to access MHRA’s device registration and certificates of free sale services via an online portal. MHRA also thinks the new model will help its staff to provide information to companies faster and in a more cohesive manner.
Spain Posts Q&A on Regulatory Status of Autologous Plasma
The Spanish regulator has released a question and answer document on autologous plasma. Officials at the Spanish Agency of Medicines and Medical Devices (AEMPS) published the text in response to questions about the regulatory status of products that fall into the autologous plasma category.
AEMPS established a framework for autologous platelet-rich plasma (PRP) in 2013 in response to the sharp rise in the use of the material. PRP is obtained by processing blood to remove red blood cells and thereby increase the concentration of growth factors. The composition of PRP led some to think it may improve outcomes in patients with conditions including tendonitis and osteoarthritis, but, as AEMPS noted in 2013, growth in the use of the material has outpaced the accumulation of evidence.
Since establishing a framework for PRP in 2013 AEMPS has fielded questions from people who are unclear on aspects of the regulations. In response, AEMPS has published a Q&A document that runs through uncertainties about whether PRP is considered a medicine, how it can be produced and whether there is efficacy data to support its use.
The section on the minimum guarantees of quality in the production of PRP accounts for the lion’s share of the document. In that section, AEMPS details the differences between two ways of making PRP and clarifies that, whichever approach is used, the devices deployed must carry CE marks. The document also walks manufacturers of PRP through the process for initiating inspections, and details the quality and safety standards they must meet.
Other sections of the document feature questions such as whether PRP can be classed as an advanced therapy medicinal product and whether providers of PRP treatments can advertise their services. The answer to both those questions is no.
AEMPS will continue to review and update the document based on its interactions with interested parties.
AEMPS Q&A (Spanish)
Danish Regulator Starts Assessments of Medicinal Cannabis Trial Applications
The Danish Medicines Agency (DKMA) has begun the review of applications for its medicinal cannabis research funding. DKMA received 12 submissions and has forwarded them to the group that will assess the eligibility of the applications.
Oncethe uneligible applications are weeded out, a follow-up group will review the filings and make a recommendation to DKMA. The regulator will then make a recommendation to the Ministry of Health, which has the final say on which of the applications will receive funding. DKMA expects one to two applications to receive government support.
DKMA is looking to the successful applicants to add to scientific and regulatory understanding about medicinal uses of cannabis. The projects that generate this understanding could be randomized clinical trials, case-control studies or studies comparing the use of cannabis products to conventional treatments.
DKMA Notice (Danish)
Ireland Starts Recruiting for Director of Human Products Authorization and Registration
Ireland has begun recruiting for a director of human products authorization and registration. The Health Products Regulatory Authority (HPRA) is looking for someone with three years of experience at a senior level in regulatory affairs or a related field to fill the role.
The new hire will report to HPRA’s chief executive and play a leading role in the agency’s efforts to expand its influence over drug authorizations in Europe. That focus frames the appointment as part of HPRA’s move to fill the vacuum created by the likely post-Brexit loss of MHRA’s support for EMA’s activities.
HPRA is looking for someone with considerable experience to take on this task.
“Significant experience in the leadership and motivation of large, high performing multi-disciplinary team(s) is required as is a strong track record in the area of performance management with the ability to communicate direction to the team, set standards for high performance and drive the achievement and delivery of results,” HPRA wrote in the job advert.
EMA has extended the deadline for applying to win funding for post-authorization effectiveness and pharmacoepidemiology studies. The agency wants organizations to run studies to generate data to support regulatory decision-making, or carry out research into the effectiveness of regulatory measures. The deadline for applying for the contract is 6 February, four days later than originally planned. Tender Amendment
Defective Buccolam oral syringes have prompted a warning from EMA. The agency issued the notice after learning of cases in which a fault has led to patients ingesting or inhaling syringe caps. EMA Notice