Welcome to our new website! If this is the first time you are logging in on the new site, you will need to reset your password. Please contact us at raps@raps.org if you need assistance.
The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.
Resources, news and special offers to support you and your professional development during this difficult time.
One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.
Your membership opens the door to free learning resources on demand. Check out the Member Knowledge Center for free webcasts, publications and online courses.
Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.
Download your copy of the new events calendar and see all the online workshops, conferences, RAC exams and European online workshops RAPS has planned for 2021 at a glance.
Registration is now open for RAPS Euro Convergence 2021! Attend to join peers from EU and around the world to gain insights and exchange ideas on the regions most pressing issues.
An invaluable resource for any professional engaged in designing, composing, compiling, or commenting on regulatory documentation
From self-assessments to help you identify your strengths and areas to focus on to reference books and online courses that will help you fill in the gaps in your regulatory knowledge, RAPS has the resources to help you prepare for the RAC exam.
The site navigation utilizes arrow, enter, escape, and space bar key commands. Left and right arrows move across top level links and expand / close menus in sub levels. Up and Down arrows will open main level menus and toggle through sub tier links. Enter and space open menus and escape closes them as well. Tab will move on to the next part of the site rather than go through menu items.
Posted 02 March 2017 | By Nick Paul Taylor
Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.
European biopharma trade groups have jointly set out criteria for deciding on the new home of the European Medicines Agency (EMA). The three trade groups detailed their desire for the selection process to consider six essential criteria in a letter to a high-ranking health official at the European Commission.
The criteria proposed by the European Federation of Pharmaceutical Industries and Associations (EFPIA), EuropaBio and Medicines for Europe are intended to minimize the risk of disruption when EMA moves from its current home in London, United Kingdom to a new location as part of Brexit. EFPIA and its co-signatories are publicly staying out of discussions about which country should host EMA post-Brexit, but through their criteria have described the type of location they want to win.
Three of the criteria relate to local regulatory capacity. With EMA currently reliant on the support of the Medicines and Healthcare Products Regulatory Agency (MHRA), the trade groups want to ensure the national regulatory agency of the new host nation is able to step up its involvement in EU-wide activities. This shift should not come at the expense of non-EMA work, the trade groups argue, and as such the local government must be prepared to increase spending.
The remaining three criteria relate to more general characteristics of the proposed host cities. The trade groups want the commission to choose a location with easy access to an airport, transport links to the rest of the EU, adequate local hotel capacity and enough space for EMA meetings and events. Finally, the letter’s authors request the commission minimize disruption for EMA staff by factoring in the availability of international schools, labor market access and social security.
EFPIA’s criteria echo the cases made by some of the candidates to host EMA to date. Denmark, the Netherlands and other countries have talked up their regulatory and scientific capacities, and the livability of their cities for people relocating from London. If EMA is unable to persuade the vast majority of its staff to relocate from London with it, the regulator could struggle to provide normal services with its reduced headcount. The trade groups want to avoid this scenario.
As such, while the letter shies away from the debate over which city should host EMA, the criteria favor countries in western Europe that have the necessary regulatory capacity and make it easier for staff to decide to relocate.
The organizations made their case in a letter to Xavier Prats Monné, the director general of the Directorate-General for Health and Food Safety. Responsibility for choosing a new site for EMA will fall on Monné and the rest of the commission. Officials are yet to propose a timeline for making the decision, but many people affected by the relocation want clarity this year.
Letter
EMA has released a guideline on the toxicological risk veterinary medicines in groundwater pose to human health. The text proposes a methodology for assessing whether the concentration of a drug in groundwater constitutes a risk to the health of humans who drink the contaminated liquid.
Today, regulators view concentrations above 0.1 µg/l as unacceptable. At lower concentrations, no risk is anticipated and, as such, no regulatory action is required. However, EMA is now considering whether this is the right approach.
The 0.1 µg/l cutoff point was derived from the detection limit of analytical methods at the time. Development of more sensitive tests capable of detecting small quantities of contaminants has made a new approach possible. As there is evidence some drugs can do harm at levels below 0.1 µg/l, EMA thinks there is value in using these new, more sensitive tests to make more informed judgements about the risks posed by groundwater contamination.
EMA is proposing the industry use two formulas that factor in the acceptable daily intake of an active ingredient, daily consumption of drinking water, predicted concentration in groundwater and other variables to rule whether the risk to human health is acceptable. If the predicted concentration in groundwater exceeds the maximum tolerable concentration in drinking water, the risk to human health will be deemed unacceptable.
The human health formulas are accompanied by other calculations for assessing the risk a drug poses to groundwater ecosystems. EMA has given the industry until the end of August to comment on the draft.
Draft Guideline
EMA’s Committee for Medicinal Products for Veterinary Use (CVMP) is planning to change its recommendation for the basic surveillance of Eudravigilance Veterinary (EVVet) data. CVMP wants to make the revisions to improve pharmacovigilance surveillance by integrating the evaluation of periodic safety update reports (PSURs) into the process.
The committee began work on revisions to its original recommendation about basic surveillance within months of the adoption of a related pharmacovigilance document in 2015. CVMP felt the revision was needed to avoid overlap and discrepancies between the two texts. This led to the publication of recommendations that seek to improve surveillance principles and clear marketing authorization holders (MAHs) to simplify PSUR content.
CVMP is proposing to allow MAHs to skip the provision of a line listing in certain circumstances, and not attach the summary of product characteristics to the PSUR. The proposals are part of an attempt to avoid wasted effort by adopting a risk-based approach to PSURs and their content.
EMA is accepting feedback on the proposals until the end of August, beyond which it plans to see how the new way of working functions in the real world.
“The revised recommendation will be trialled initially in a pilot phase. Based on the experience gained and as the supporting electronic systems are developed further, as necessary, implementation of the revised recommendation is expected for all [centrally authorized products]. It is envisaged that the recommendation will be reviewed within a few years in light of the experience gained following implementation,” CVMP wrote in its recommendation.
Draft Recommendation
The State Institute for Drug Control (SUKL) of the Czech Republic has established guidelines for the submission of trade secrets to authorities. SUKL created the advice to help companies identify documents that contain trade secrets when submitting files to support reimbursement decisions.
Applicants are advised to clearly mark any files or emails that contain trade secrets. SUKL also wants companies to refer to the documents that contain trade secrets in their accompanying letters and tick the appropriate box on the application form to alert the receiver to the presence of sensitive materials.
When a document contains a mix of classified and publicly available information, SUKL wants companies to submit two versions, one complete copy and another with the trade secrets redacted.
SUKL thinks the guidelines will ensure authorities can access the information they need to make pricing and reimbursement decisions without compromising trade secrets.
SUKL Notice (Czech)
Tags: EFPIA, veterinary drugs, Eudravigilance
Regulatory Focus newsletters
All the biggest regulatory news and happenings.