Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.
Three Years After First Consultation, EMA Again Seeks Feedback on Antimicrobial Resistance Draft
The European Medicines Agency (EMA) has released a draft guideline on the use of antimicrobials in food-producing animals for consultation for the second time. EMA sought feedback on the first antimicrobial resistance draft three years ago, after which development of the guideline stalled.
Only five people and organizations submitted publicly available feedback on the first draft, but the advance of the document stopped nonetheless. The feedback to the original draft raised concerns about the risk of burdening veterinarians with administrative work and stifling development of novel antibiotics. In responding to the feedback, EMA has added eight pages to the guideline.
Key sections of the guideline such as the discussion of how to assess the antimicrobial resistance risk posed by a product are largely unchanged from the 2015 draft. Elsewhere, EMA has added lengthy sections and charts.
The new sections include discussions of how applicants should approach the categorization of risk factors and comment on their assumptions. EMA added the sections in recognition of the likelihood of there being substantial gaps in the data and understanding of risk pathways. Given these issues, EMA is advising applicants to take a qualitative, not quantitative, approach to risk assessments. If a lack of information forces a company to make an assumption, EMA expects this to be discussed.
Elsewhere, EMA has added a chart showing how to map connections between hazards and possible consequences, such as a threat to human health stemming from the emergence of drug-resistant bacteria. The agency has also changed and expanded two existing tables on the data requirements of release and exposure assessments, and added a discussion of how to categorize the risks posed by an antimicrobial.
EMA is accepting feedback on the second draft of the guideline until the end of October.
, Original Feedback
Ireland’s HPRA to Move to Electronic Workflow for Human Medicine Applications
The Health Products Regulatory Authority (HPRA) is set to move to an electronic workflow for human medicine marketing authorization filings on 7 August. HPRA is warning applicants that there may be some disruption to timelines and service levels during and after the transition.
Adopting a new system for assessing and issuing marketing authorizations will enable HPRA to add extra features that improve its operations and interactions with applicants. However, in the interim the transition could cause problems. HPRA hopes to maintain its timelines and service levels during the move, but would also appreciate “understanding and patience” from applicants as it makes the switch.
The transition will have some effects on applicants regardless of how smoothly the process goes. In the new system, HPRA will use alphanumeric case reference codes, not the seven-digit numbers it assigned companies in the past. HPRA thinks it will still be able to identify cases that began under the old system.
HPRA is phasing out the product specific details (PSD), too. Applicants used to submit PSD alongside the license cover page and summary of product characteristics (SPC). Going forward, HPRA will only ask for the cover page and SPC. The agency will log the information previously communicated in PSD on its database. This information will stay a registered part of the product marketing authorization.
The final set of changes relate to communications. All applications made through the new system will receive a dedicated email address based on the case number. Applicants will use the email address to send information directly to the HPRA team handling their case. HPRA will reply from the address, too.
UK to Reschedule Cannabis-Derived Medicines, Paving Way for Prescriptions
The United Kingdom is set to reschedule cannabis-derived medicinal products. The changes will free senior clinicians from the need to apply to an independent expert panel to prescribe the medicines, potentially simplifying and expanding access.
Under the current system, senior clinicians can access medicinal cannabis for their patients but must go through a bureaucratic process to do so. The process was criticised following reports of children with refractory epilepsy who were unable to access cannabis-derived products despite cannabis oil appearing to ease their symptoms. That backlash led to a review of whether cannabis should retain its Schedule 1 status, which is reserved for drugs with no therapeutic value.
The first part of the two-step review found evidence that medicinal cannabis has therapeutic benefits. That done, the Advisory Council on the Misuse of Drugs assessed the harms and benefits of medicinal cannabis, going on to conclude such products belong in Schedule 2. The rescheduling is set to take place later this year.
Ahead of the change, the Medicines and Healthcare products Regulatory Agency and the Department for Health and Social Care will develop a clear definition of “cannabis-derived medicinal product.” That definition will inform the rescheduling and ensure only forms of cannabis deemed to have therapeutic value become available on prescription.
The UK expects to complete the process in the fall. Until then, senior clinicians can apply to access the products via the independent expert panel without paying the typical fees. The UK is also waiving the fees for applications already granted by the panel.
EMA Ends London Trainee Program as Move to Amsterdam Nears
EMA has stopped running its full trainee program. The agency decided against organizing another full intake of trainees because it will leave its current headquarters in London in March.
In the past, EMA has accepted groups of trainees in October and again in April. The trainees receive £1,550 ($2,000) a month and work at units across the agency for six months or more. As EMA will move to Amsterdam five months into the October intake’s time at the agency, the regulator is putting the program on hold. Trainees at EMA in March will not move to Amsterdam with the agency.
EMA may have vacancies for specific trainee positions, but the full scheme will only start up again once it is established in Amsterdam. The temporary cessation of the program means EMA will have to get through the coming period without its normal quota of trainees and anyone who chooses not to relocate to Amsterdam.
EMA’s Committee for Medicinal Products for Veterinary Use
(CVMP) has released three draft documents for consultation. CVMP is seeking feedback on a reflection paper on dose optimization, a guideline on vector-borne diseases in cats and dogs and a discussion of stability testing. The flurry of activity precedes the summer lull. EMA will accept feedback on the drafts through the rest of this year and in two cases into 2019. Reflection Paper
, Stability Testing
is considering whether to suspend the marketing authorizations of six products that contain the excipient diethanolamine. The Irish regulator began the review after CVMP
ruled food produced from animals that received medicines containing diethanolamine could pose a risk to consumers. HPRA will talk to the manufacturers of the products and liaise with an independent expert advisory committee before reaching a conclusion. HPRA Notice
EMA’s Committee for Medicinal Products for Human Use
(CHMP) has recommended Alnylam Pharmaceuticals
’ pioneering RNAi therapeutic Onpattro
for approval. CHMP also recommended limiting the use of Bayer
to a subset of metastatic prostate cancer patients. EMA Notice