Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.
UK Parliament Report: Divergence From EMA Will be Expensive
The UK’s Business, Energy & Industrial Strategy Committee released a report on Thursday raising concerns about the prospect of regulatory divergence between the UK and the European Medicines Agency (EMA) as “the deepest concern” for industry.
The report notes that separate UK regulations “could impose extra costs of £45,000 for each new product released, making the UK an unattractive market for new and innovative medicines.”
But the call for continued membership in the EMA, in some form, has been echoed by other UK officials
. Some experts have said the relationship between the UK’s MHRA and EMA could mirror the way in which Switzerland cooperates with the EMA
While acknowledging the need for EMA’s headquarters to move to Amsterdam, the committee said it recommends that as part of a new association with the EMA, the UK government should seek to retain a presence for EMA jobs and facilities in the UK.
Rachel Reeves, chair of the committee, said in a statement: "The Government’s own analysis identifies pharmaceuticals as the sector for which UK/EU market access is the most important given the industry is reliant on friction-free border movement for their products. Any delays at the border faced by short-life pharmaceuticals for emergency treatments would have a hugely detrimental impact on patients.”
Ireland Extends Inspection Notification Window After Spate of Cancellations
The Health Products Regulatory Authority (HPRA) of Ireland has increased the notification period for good distribution practice (GDP) inspections. HPRA took the step in response to an increase in the number of companies that made short-notice requests to reschedule or cancel inspections.
Typically, HPRA gives companies six weeks notice about GDP inspections. This is intended to give organizations enough time to ensure they have the resources in place to facilitate the visit of HPRA’s staff. However, the notification period is failing to ensure the process goes smoothly. More and more companies are pulling out of inspections at short notice, leaving HPRA with too little time to arrange another visit to fill the gap in its schedule.
Faced with the problem, HPRA is increasing the notification period to at least eight weeks. HPRA will send the date via email first, before following up with a more detailed notification featuring requests for documents closer to the visit.
The agency thinks the eight-week window will help companies manage their resources and plan such that there is no need to reschedule. HPRA will still consider rescheduling requests in some instances, though. If a company contacts HPRA well before the inspection to say key staff will be missing on the chosen date, the agency will try to accommodate changes to the schedule.
That said, HPRA also reminded companies that they should have processes in place to cover for the absence of staff. HPRA expects companies’ key personnel to delegate their duties to a deputy while they are absent. The deputy should have the knowledge and oversight needed to effectively carry out the absent employee’s responsibilities, including the management of inspections.
Belgium Revises Guidance on Joint Clinical Trial Pilot
The Belgian regulatory agency has revised the guidance on a clinical trial application processing pilot project. Version 4.0 of the text features new sections addressing the Common European Submission Portal (CESP) and questions about the voluntary pilot project.
Belgium’s Federal Agency for Medicines and Health Products (FAMHP) is running the pilot with ethics committees in preparation for the implementation of the European Clinical Trial Regulation. Today, FAMHP and the committees largely operate independently. That separation will become untenable under the incoming regulations, which will require member states to provide single decisions to the European Union clinical trial portal.
In response, FAMHP and the ethics committees set up a pilot project to develop and refine processes and procedures for the joint assessment of clinical trial applications. The collaborators published the first version of a guide to the pilot at the start of last year.
The latest update to the document addresses e-submissions through CESP. Knowledge of how to use the portal will become vital on 1 October, when the pilot project will stop accepting dossiers filed via Eudralink. All submissions from then on must go via CESP. FAMHP sees the restriction as a way to “harmonize the way the different type of dossiers are submitted” to its R&D unit.
In anticipation of the change, FAMHP has added an annex on CESP to its guidance. The section explains the purpose and benefits of CESP, which was created to facilitate the exchange of filing information between applicants and regulators. FAMHP also walks readers through the process of submitting information via the portal and alerts them to additional training materials.
Version 4.0 of the guidance features other changes, too. FAMHP has added another annex that covers important points about the preparation of pilot dossiers and answers related questions. The questions cover topics including the timelines and fees associated with the pilot.
EMA Rewrites General Conditions for Recruitment and Employment
The European Medicines Agency (EMA) has rewritten its general conditions for recruitment and employment. The new document features an overhaul of the previous conditions and incorporates formerly separate texts focused on temporary agents and contract agents.
Officials created the document to provide a comprehensive overview of the categories of people who work at EMA, how they are recruited and the principles they must abide by when working at the agency. Previously, EMA outlined the general conditions in one document and covered the specific considerations of its two main groups of employees separately.
The latest document explains how temporary agents and the contract staff who work under them are subdivided by rank and function and explains the level of education and professional experience needed to attain each position.
A separate section details the recruitment process for temporary and contract agents. The section explains who is eligible for the jobs and the language skills they must possess, before walking readers through the application process.
Temporary and contract agents are the backbone of EMA, but various other groups of people are also involved with the agency. These include national experts on secondment, interim staff from temping agencies, contractors and trainees. In each case, the document details how people in the groups can come to work at EMA.
All employees are subject to a code of conduct and certain rules regarding confidentiality and conflicts of interest. The document briefly discusses these principles and links out to lengthier explanations.
CHMP Adopts ICH Guideline on Nonclinical Evaluation of Cancer Drugs
The Committee for Human Medicinal Products (CHMP) has adopted a guideline on the nonclinical evaluation of cancer drugs. CHMP adopted the International Conference on Harmonization (ICH) document after gathering feedback on it over the second half of 2016.
The text, ICH S9, is a question and answer document that addresses the challenges regulators and drug developers have encountered when trying to implement the related S9 Step 4 guideline. That guideline, which was supposed to mark a significant step forward in cancer drug development, has been undermined by divergent takes on how it is interpreted. Adoption of the Q&A is intended to clarify the meaning of the earlier document while pushing the 3R animal testing agenda.
Reflecting the fundamental uncertainties about the interpretation of Step 4, the first seven questions of the Q&A address the scope of the guideline. This section is intended to clear up common misunderstandings, such as the belief the guidance only applies when the patient’s life expectancy is around three years. The Q&A clarifies that life expectancy has no bearing on the application of the guideline.
The second section focuses on studies to support nonclinical evaluation. Answers in this section clarify that in vitro
studies can be used to characterize a drug’s anticancer activity and that in vivo
genotoxicity testing is unnecessary if the bacterial mutation test is positive.
Other sections of the Q&A address nonclinical data to support clinical trial designs and marketing and questions that do not fit into the other categories. The document will come into effect in the EU on 16 November.
The Danish Medicines Agency
(DKMA) has introduced an e-learning module about online medicine sales. DKMA created the module to explain the rules covering the online trade in human and animal medicines. DKMA Notice
The Dutch Medicines Evaluation Board
(MEB) has temporarily extended the shelf life of radiopharmaceutical diagnostic imaging agent tilmanocept
. MEB took the step in response to a shortage of the agent. MEB Notice