Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.
PRAC Adopts Strategy to Monitor Effects of Risk-Minimization Measures
The Pharmacovigilance Risk Assessment Committee (PRAC) has implemented a strategy to enable it to measure the impact of its activities. Officials have designed the strategy to deliver feedback on the effectiveness of risk-minimization measures and other actions.
PRAC, a part of the European Medicines Agency (EMA), has picked out four key areas of focus for the strategy: Risk minimization, specific processes, enablers of effective pharmacovigilance and method identification and development. Gathering broader, more comprehensive data on these activities is expected to support a positive feedback loop, in which improved understanding of the success rates of various actions feeds into refinement and optimization of future policies. At the same time, the risk-minimization data should give PRAC a clearer view of the risks and benefits of particular drugs.
The committee will work on the risk-minimization aspect of the plan with marketing authorization holders, which already gather data on the effectiveness of moves to limit the hazards posed by their products. By systematically gathering the results of these industry-led initiatives, PRAC expects to add to its knowledge of the outcomes associated with specific medicines, while simultaneously generating case studies that can inform decision making in the future. A pilot study, in which EMA and national bodies are monitoring codeine risk-minimization efforts aimed at children, is underway.
PRAC has designed the three remaining elements of the strategy to gather more general feedback that is less tied to specific drugs. The monitoring program will, for the first time, deliver data on the impact of spontaneous reporting of suspected adverse events, signal detection, signal management and other pharmacovigilance processes. PRAC is also looking into key enablers of pharmacovigilance, such as the engagement of healthcare professionals, to assess whether tweaks to its approach can boost the effectiveness of its activities.
While PRAC already has a high-level overview of how these data-gathering activities will play out over the next three years, it is yet to decide on the specifics of how it will implement each aspect of the strategy. EMA is working with the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP) to develop methodologies for the impact studies. Meetings to discuss the designs of surveys PRAC plans to put to patients, healthcare professionals and the industry are penciled in for later this year. Data gathering will happen in parallel to these preparations.
PRAC Statement, Monitoring Strategy
EMA Revises Conflict of Interest Rules for Members of Management Board
EMA has updated its policy on handling conflicts of interest among members of its management board. The revisions are intended to bring the approach in line with the policy applied to members of scientific committees, which was overhauled 12 months ago to increase flexibility.
Prior to the overhaul, EMA was concerned the rigidity of its conflict of interest policy was affecting its ability to recruit experts to its committees. While the management board has no role in deciding on marketing authorizations, its control of the budget and the annual work program means EMA is keen to ensure it is also staffed by impartial, high-quality people. To this end, a risk-based approach that takes into account the nature of a candidate’s declared interest, when it happened and the activity and action of the management board is due to come into force on 1 May.
“The updated policy brings the rules for board members in line with those for scientific experts, whilst also taking into account the specific role of the Board, without lowering the bar on the independence of its work,” Noël Wathion, chief policy adviser at EMA, said. Anyone with current, direct interests in the pharmaceutical industry, such as a strategic advisory role or employment, is automatically barred from holding a seat on the management board. Beyond this absolute, the status of potential candidates is to be assessed in light of the specifics of their situation.
EMA is prohibiting anyone who has had a direct interest in the pharmaceutical industry in the past three years from acting as chair or vice-chair. Candidates with such backgrounds can serve as board members or topic coordinators, although they may be prohibited from taking part in decisions on specific topics. EMA is taking the same approach to the full spectrum of conflicts of interest and management board roles, giving it a framework to enable it to decide whether, for example, a person with a close family member in the pharmaceutical industry can serve as chair of the board.
EMA Notice, COI Policy
MHRA to Open Board Meetings to Public Under Pilot Project
The United Kingdom Medicines and Healthcare Products Regulatory Agency (MHRA) is planning board meetings that are partly open to the public. MHRA is allowing up to 10 members of the public to attend the meetings and, at the discretion of the chair, ask questions at the end of each discussion.
In proposing the idea, MHRA is splitting its meetings into two parts, the first of which will be open to the public. The second, private session will cover topics such as policy matters in development and product or safety issues that MHRA is unwilling or unable to discuss publicly. Even with this caveat, the pilot project still represents a lurch toward greater transparency at MHRA.
The agenda of the first public meeting, which will take place on 12 February, is already available. MHRA will use the session to discuss its progress in genomics and companion diagnostics, the status of its vigilance strategy and the advance of its agenda to build academic relationships. Attendees will have a chance to ask questions about each topic.
A second public meeting is scheduled for later this year. At this stage, the initiative is still in a pilot phase and MHRA is yet to say publicly when it will decide on its long-term fate or disclose the factors it will consider when making the determination.
MHRA Statement, Meeting Agenda
EMA Updates Advice Documents in Response to Changes to Pharmacovigilance
EMA has updated three of its advice documents following changes to its pharmacovigilance system.
The changes include the addition of sections to texts covering pre- and post-authorization advice, as well as a question and answer document about the implementation of variations guidelines.
Each of the documents has been affected by the changes to the submission of type IA variations that EMA agreed upon late last year. From 1 February, instead of asking companies to inform them of changes to the details of their Qualified Person Responsible for Pharmacovigilance, regulators will rely on the Article 57 database. EMA has updated the advice documents to reflect this change.
Both the pre- and post-authorization advice documents now feature sections on the need to enter and maintain the location of the pharmacovigilance system master file in XEVMPD, the eXtended EudraVigilance Medicinal Product Dictionary, as well as questions and answers related to multiple other aspects of the current model for monitoring drug safety.
Pre-Authorization, Post-Authorization, Practical Q&A
EPC Rewrites Raman Spectroscopy Chapter to Reflect Rise of PAT
The European Pharmacopoeia Commission (EPC) has completely rewritten its general chapter on raman spectroscopy. EPC has used the update to reflect the growing role of raman spectroscopy in Process Analytical Technology (PAT) and revise its list of reagents used for verification.
Officials first published a chapter on raman spectroscopy back in 2002, since when the design of the instruments and their role in the pharmaceutical industry has evolved. The latest update is intended to reflect these changes. As such, the chapter is now designed to be applicable to the use of raman spectroscopy in a PAT environment, a way of working that was in its infancy in 2002.
Other revisions to the text include an update to the list of reference standards or reagents used for verification of the wavenumber scale. Polystyrene and paracetamol have replaced indene and naphthalene on the list. EPC picked paracetamol because of its stability and the ease with which it can be worked. The updated chapter is due to come into force on 1 April.
EMA has scheduled a public workshop on extrapolating safety and efficacy in drug development for May. The plan is to present a reflection paper on extrapolation across age groups at the session, in which it will look at considerations related to the development of pediatric medicines. EMA will use the workshop to gather feedback on the paper. EMA Notice