Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.
Facing Cyber Threats, EMA Seeks IT Security Experts to Review Data Policies
The European Medicines Agency (EMA) is looking for IT security experts who can help ensure its data are safe and properly managed. Officials hope to create a list of experts they can turn to for periodic assistance with reviewing data security policies and other mechanisms intended to stop breaches.
EMA’s functions put it in possession of lots of sensitive information. To develop and market products, companies need to share information with EMA that is confidential and potentially very valuable to competitors and investors. This makes EMA and other regulators a target for unscrupulous actors that want to gain an unfair advantage. Mitigating these threats requires specialized knowledge.
To access such knowledge, EMA has put out a call for contractors with expertise in data classification, retention and disposal. The experts selected by EMA will receive up to €450 ($528) a day to work with the agency’s technical lead and head of information security on certain data-related tasks.
EMA envisions the experts reviewing a range of its activities, including its data security policies and monitoring controls, and its data classification, management and disposal procedures. Other planned reviews will look at breach notifications, data sharing policies and the registers EMA uses to track access to sensitive data. By enlisting outside experts to perform these reviews, EMA hopes to keep its policies and processes up to the standards needed to protect its data.
The call for external experts will result in a list of contractors capable of performing these tasks. EMA is restricting the work to contractors who have five or more years of experience of working in information security systems. The list will remain valid for five years, and EMA will continue accepting new applications throughout almost all of that time.
, Job Profile
Swissmedic Overhauls Medical Device Certification Process to Avert Resourcing Crisis
The Swiss Agency for Therapeutic Products (Swissmedic) is completely overhauling the way it issues medical device export and manufacturing certificates. Swissmedic committed to the major changes after concluding rising certificate requests and processing times will lead to delays if the status quo is maintained.
Swissmedic issues export certificates — known by the abbreviation “FSC” — to companies with an office in Switzerland that want to ship devices to certain countries that do not recognize the CE mark. Today, companies can request FSCs from Swissmedic by sending a completed form and evidence of compliance by post.
Between 17 September and 19 October, Swissmedic will phase out this process in favor of an online system. Once the transition period ends, medical device companies will need to use Swissmedic’s online portal to request FSCs. Instead of a paper form, companies will complete and file an active PDF that “updates dynamically during completion.”
Swissmedic has revised its offering — limiting the options to one type of export certificate and one type of attestation — and redefined the scope of the services it provides to companies.
These changes should enable Swissmedic to process applications faster, but it is retaining its 30-day target for now. Swissmedic thinks it may exceed the time limit in the early days of the new system but will get quicker over time. If Swissmedic consistently reduces its processing times to less than 30 days, it may change the target time in the service agreement.
EMA Clarifies Regulatory Status of Veterinary Vaccine Adjuvants to Encourage Innovation
EMA has released a draft guideline to clarify the regulatory status of adjuvants used to increase the effect of veterinary vaccines. The clarifications are intended to encourage companies to use modern adjuvants that are less likely to induce local or systemic reactions in animals.
Adjuvant technology has advanced since EMA published its current advice on the topic 20 years ago. However, this technological progress has failed to translate into the availability of veterinary vaccines that incorporate the latest adjuvants, depriving animals and veterinarians of safer products. In 2016, EMA identified the inadequacy of its guidance on establishing adjuvant safety as one explanation for the lack of modern adjuvants on the market.
The draft guideline published this week is intended fix the perceived inadequacy of EMA’s current advice. With that in mind, EMA has provided details of the quality, safety and efficacy data requirements developers of adjuvanted veterinary vaccines must meet.
EMA is accepting feedback on the draft guideline until 15 January 2019.
Dutch MEB Follows FDA in Restricting use of Keytruda and Tecentriq
The Dutch Medicines Evaluation Board (MEB) has restricted the use of Keytruda and Tecentriq in bladder cancer. MEB took the action after studies showed patients with low PD-L1 levels fared better on platinum chemotherapy than Keytruda or Tecentriq.
Keytruda and Tecentriq are part of a wave of PD-1/L1 checkpoint inhibitors that have improved the prospects of patients with a range of cancers. However, in May two studies linked cisplatin or carboplatin-based chemotherapy to better survival than the checkpoint inhibitors in bladder cancer patients with low PD-L1 levels. That led the United States Food and Drug Administration (FDA) to restrict the use of the drugs for bladder cancer.
Now, MEB has followed FDA’s lead. The Dutch agency is recommending doctors only use Keytruda or Tecentriq as first-line treatments for bladder cancer if the patient’s PD-L1 expression is above a certain threshold. MEB has placed no restrictions on the use of the checkpoint inhibitors in second-line settings.
, Tecentriq Notice
EMA Successfully Navigates Pharmacovigilance Crisis Simulation
EMA has shared details of a pharmacovigilance crisis simulation it performed last year. The exercise assessed EMA’s response to the suspension of fictitious centrally and nationally authorized products following reports of patient deaths in a member state.
In the exercise, EMA held an incident review network teleconference, which led to the formation of the EU-Executive Task Force. EMA tasked this group with confirming the situation was a crisis and determining how to respond. The European Commission and member states were involved in the exercise.
Once the exercise was over, EMA concluded the EU Regulatory Network Incident Management Plan for Human Medicines that is in place to help deal with emergencies works well. The agency also identified some prerequisites for effective responses to crises, including having clear roles and responsibilities, good communication channels and a streamlined process.
These lessons will inform EMA procedures and guidance, as well as future crisis simulations.
has revised its guidance on time limits for authorization applications. The agency made the changes in response to the failure of applicants to provide all relevant data at the time of filing, despite having access to the required records. These failures force Swissmedic to request the missing data as part of its list of questions. To improve the situation, Swissmedic has revised the process so that applicants may incur additional costs if they fail to provide the data upfront. Swissmedic Notice
The Danish Medicines Agency
(DKMA) has stopped charging fees for commercial Phase I clinical trials and all studies run by noncommercial sponsors. DKMA made the changes as part of an effort to make Denmark a more attractive location for clinical research. DKMA Notice
has published a guide to the stratification of antimicrobial sales data by species. EMA Guide