Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.
Brexit Sparks Hiring Drive at Danish Medicines Agency
The Danish Medicines Agency (DKMA) has become the latest organization to increase its hiring in response to Brexit. DKMA is taking on extra staff at its Medical Evaluation and Biostatistics (MEB) unit to bolster the new department’s ability to help the European Medicines Agency (EMA).
As it stands, the department employs 22 people and works with the same number of part-time specialists. DKMA has posted seven job adverts over the past two weeks, including an English-language post that aims to fill multiple roles at the MEB unit.
DKMA is looking for a hematologist, oncologist, central nervous system specialist and two clinical pharmacologists or internal medicine physicians. One pharmacologist or physician will focus on pharmacovigilance. The other will handle licensing tasks. Regardless of their specialization, DKMA expects applicants to have an interest in and flair for assessing clinical research, scientific expertise and proficiency in the English language.
The job posting suggests DKMA wants to increase the headcount of the unit by more than 20%. DKMA embarked on the MEB hiring drive in response to the United Kingdom’s decision to leave the European Union.
”Brexit has triggered extra tasks for the remaining agencies in the EU. In this respect, we have to handle increasing volumes of work,” Nikolai Brun, head of the unit taking on the extra employees, said.
The same rationale underpinned job openings created by Spain’s Agency of Medicinal Products and Medical Devices (AEMPS) last month. AEMPS put out a call for 40 new recruits to ensure it can take on extra work from EMA.
Both countries are in the running to host EMA after it leaves London, but Brun said the hiring push is independent of the country's bid for the agency. Rather, DKMA wants to expand its capabilities so it can help EMA through its upcoming relocation and transition period, regardless of the identity of its new home.
EMA sparked such thinking by asking member states whether they were willing to invest to fill the gaps in capacity and capability it anticipates arising as a result of Brexit. Some of those gaps will result from the anticipated loss of the UK Medicines and Healthcare Products Regulatory Agency’s assistance. Other gaps will emerge when some EMA staff opt to stay in London rather than move to the agency’s new home.
DKMA Update, Job Posting
EMA Prepares Industry for 10-Day IT System Shutdown
EMA has warned the industry some of its IT systems could be offline for 10 business days in the run up to the go-live date for the latest version of EudraVigilance. The disruption is forecast to run from 8 to 21 November, the day before the new version of the adverse reaction system starts up.
Over this period, key components of EudraVigilance Veterinary, EudraVigilance (Human) and the Extended EudraVigilance medicinal product dictionary (XEVMPD) will be partially or totally offline.
Registration systems for the human and veterinary versions of EudraVigilance will be unavailable. As such, EMA wants to receive registrations for new organizations or changes to existing users by 15 October. That will give EMA enough time to process the registrations before the system goes down next month.
Once the systems go down, the applications trial sponsors, competent authorities and marketing authorization holders use to report adverse reactions tied to animal medicines and experimental human products will be unavailable. Patients, healthcare professionals and veterinarians will still be able to report adverse reactions. However, gateway organizations will only be able to report events that happened in Germany, Spain and the UK.
Other key systems such as the periodic safety update report repository, electronic application forms and the EudraCT database and data warehouse will stay online. However, the fact XEVMPD is unavailable will affect their operation. EMA wants companies to be aware of the limitations these systems will face over the transition window, such as the inability to update product data, and take steps now to mitigate their impact.
EMA Statement, Technical Note
Ireland Blames Brexit for Proposed Increase in Regulatory Fees
The Irish Health Products Regulatory Authority (HPRA) has blamed Brexit for its decision to raise its fees next year. HPRA has frozen its fees since 2010, but with Brexit uncertainty adding to existing financial challenges it thinks this will be impossible in 2018 and potentially the following year, too.
If the changes released for consultation come into force, HPRA will enact a general fee increase of 2% across its human and veterinary regulatory services. HPRA is proposing far steeper rate rises for certain activities, some of which it currently performs for no charge.
The regulator wants to charge €800 ($950) for investigational medicinal product dossier (IMPD) applications as they “require significant work.” HPRA currently handles IMPD applications for free. The agency also wants to introduce a fee of €146 per procedure related to marketing authorization holder divestments and bulk transfers. Companies that change reference member states as a result of Brexit are exempt from the fee.
Other fees will be hiked up. The cost of annual drug safety update reports is set to increase from €170 to €500. HPRA plans to up the fee for registering active pharmaceutical ingredient producers from €250 to €450.
In its report to outline and justify the proposed fee increases, HPRA paints itself as an organization still struggling to emerge from the financial crisis. The agency has resumed hiring and lessened its pay restrictions to cope with its growing workload and stem the loss of staff to organizations that offer better wages. This has increased its costs — necessitating the rate hikes — but was deemed necessary if HPRA is to deliver the service the industry needs.
“The impact of Brexit, the increased complexity of the European regulatory model, the ongoing implementation of new directives such as the falsified directive, the implementation of the new clinical trials directive and expanded deliverables under the strategic plan mean that the HPRA continues to require additional resources to deliver our goals and objectives,” the agency wrote.
HPRA Notice, Human Consultation, Veterinary Consultation
HPRA Posts Guide to Regulatory, Scientific Advice for GxP Activities
HPRA has posted a guide to the advice it provides in relation to good practice activities. The text lists some of the topics on which companies can seek HPRA’s advice, how they can do so and what happens after they make a request.
Ireland’s regulator put together the document to describe the advice process for GxPs, the cover-all abbreviation for good clinical, distribution, laboratory, manufacturing and pharmacovigilance practices. Examples of the topics covered by the document include plans for construction of GMP facilities, procurement of medicines and export certification for medical devices.
HPRA is asking companies that want advice on these and other topics related to GxPs to email a draft list of questions and the desired timeline for answering them to firstname.lastname@example.org. Unless the questions can be answered in writing, HPRA will arrange a meeting and, if needed, ask the company to provide documentation in advance.
has put out a call for applicants to work on a medicinal cannabis pilot project. The Danish regulator said the program will start in January and run for four years. DKMA Notice