Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.
Ireland Releases Guide to Wholesale Distribution Authorization Process
Ireland’s regulator has released a guide to help wholesale distributors make authorization application and variation requests. The Health Products Regulatory Authority (HPRA) guidance runs through all the information companies need to include on the regulatory forms covering distributor requests.
Drug distribution in Ireland is covered by local and European Union-level guidance and regulations. Under EU rules, companies need manufacturing authorization to physically receive medical products from third countries. Once in possession of the products, Irish rules dictate that the company must have a wholesale distribution authorization (WDA) for the onward supply of the materials. The new guide covers how to obtain and modify a WDA.
HPRA released the guide alongside the forms distributors need to complete to apply to receive or vary a WDA. The documents guide applicants to submit the information required by HPRA to process their requests. The details of this information are covered in greater depth in the accompanying guide.
In the guide, HPRA explains each part of the forms and the requirements placed on the applicant, which vary somewhat depending on the details of the submission. For example, if an applicant wants clearance to procure and supply products, but not hold or export them, HPRA expects to receive evidence that the company performs wholesale activities. Evidence could include mock invoices and purchase orders that show the company owns the products and has a robust business model.
HPRA also expects companies seeking new WDAs to share information about the types of customers and suppliers they work with and, if applicable, the transport model they use. The agency may check a company’s risk assessments of supply routes and transportation containers, as well as details of temperature verification or validation systems, when it inspects their operations.
MHRA Puts Cost of Replacing European Systems and Processes at £9M
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has estimated it will cost £9.3 million ($11.7 million) to replace the 40 European systems and processes it interacts with.
With MHRA and other parts of government preparing for a no-deal Brexit that may never happen, politicians are seeking to ascertain how much these activities are costing the UK government. That thinking led Ben Bradshaw, a politician in the opposition Labour party, to ask the government how much money it has given MHRA to develop new processes, systems and software.
Jackie Doyle-Price, a politician in the ruling party, responded by saying that MHRA currently interacts with 40 systems and processes that will cost an estimated £9.3 million to replace. In a separate response, Doyle-Price said cross-government Brexit funding for 2018-2019 totals £500 million.
The £9.3 million estimate is a significant sum in the context of MHRA’s budget. Last year, operating costs at MHRA were £86.8 million. From 2013 to 2015, MHRA’s total annual IT budget was less than £20 million. The uncertainty surrounding Brexit means MHRA must either spend a substantial sum on systems that may be rendered redundant or hold off and risk lacking essential systems on exit day.
France to Create Clinical Trial Fast Track for Cell and Gene Therapies
France is set to create a fast track for applications to run clinical trials of cell and gene therapies. The proposed regulatory mechanism will cut the time it takes sponsors to receive authorization to start clinical trials to 110 days.
As it stands, France’s Agence Nationale de Sécurité du Médicament et des Produits de Santé (ANSM) can take up to 180 days to assess applications to run clinical trials of cell therapies. The limit for gene therapies is 120 days. If ANSM does not respond within the statutory timeframe, it implies it has not accepted the application. Other regulators treat the lack of a response as a green light to start a trial.
These policies mean filings for clinical trials of cell and gene therapies take longer than those of other modalities. France has a 60-day deadline for authorizing or rejecting applications to run other types of clinical trials, and offers fast tracks that cut the time to as little as 25 days. Following the creation of the fast tracks, ANSM is typically processing clinical trial applications in 45 days.
Having piloted the fast track idea with other types of drug, ANSM now wants to expand its use to the processing of applications to run clinical trials of cell and gene therapies. The fast track, which ANSM plans to create early next year, will set the deadline for decisions at 110 days.
Dutch MEB to Raise Regulatory Fees by 12.5% Next Year
The Dutch Medicines Evaluation Board (MEB) is set to increase its regulatory fees by 12.5% next year. MEB thinks the increase is necessary to cover a rise in salaries, IT costs and the expansion of its activities since the last significant rate rise in 2015.
MEB revealed the rate increase on 11 December, little more than 20 days before it will take effect. In other countries such as Australia, companies have been critical of proposals to raise regulatory fees after they have set their budgets for the period affected by the rate increases.
Companies that operate in the Netherlands look to be stuck with the sharp fee increase, but MEB has offered reassurances that it will more gradually raise its rates in the future. Rather than keep its fees at the same level for several years and then raise them all in one go, MEB will tie the tariffs to annual, indexed increases.
Enpr-EMA Offers Advice to Sponsors of Pediatric Clinical Trials
The European network of pediatric research at the European Medicines Agency (Enpr-EMA) has offered to help companies access the scientific and logistical expertise of its pediatric clinical research networks.
Enpr-EMA is a collection of research networks, investigators and centers with expertise in performing clinical trials in children. The organization is involved in initiatives such as the assessment of informed consent forms for use in pediatric clinical trials and in the provision of feedback on the development of EMA guidelines affecting the use of experimental medicines in children.
Now, Enpr-EMA has shared details of how drug developers can benefit from its expertise. Enpr-EMA is encouraging sponsors of pediatric clinical trials to contact it at multiple points in the development process to discuss their strategies.
The first touchpoint comes very early in the development process. At this early stage, Enpr-EMA thinks interactions with sponsors can help to identify unmet medical needs in pediatric populations, assess knowledge gaps that can be filled by preclinical tests and design clinical development plans that target the appropriate patients and deliver data against the right endpoints.
Enpr-EMA also envisions meeting with sponsors again before submission of a pediatric investigation plan (PIP). The third meeting will take place after the PIP has been agreed upon. Finally, Enpr-EMA wants to meet with sponsors after their drugs have received approval in adults and the implementation of PIP studies.
has begun collaborating with an organization that creates animated videos to explain the most important information in the product information of a medicine in lay language. The organization, Stichting Kijksluiter, has already created 5,000 videos. Working with MEB, Stichting Kijksluiter will make the videos available to all Dutch citizens next year. MEB Notice