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 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.
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.
Share your knowledge and expertise with your regulatory peers by submitting an in-depth, evidence-based article focusing on key areas and emerging issues in the global regulatory landscape.
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.
RAPS Euro Convergence brings regulatory peers from the EU and worldwide together in one forum to gain insights and exchange ideas on the region's most pressing issues. Register today to attend 10-12 May 2021.
Registration is now open for RAPS Convergence 2021! Gather with the regulatory community 12-15 September for four days of learning, engagement, and excitement.
With contributions from more than 30 authors from seven countries, the new edition incorporates a global overview of the field and is designed to help you get the most out of your regulatory intelligence endeavors.
Regipedia is an interactive resource created to benefit RAPS members with 24/7 access to more than 2,300 regulatory terms.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
Posted 26 November 2013 | By Alexander Gaffney, RAC,
The European Medicines Agency (EMA) is out with a new draft guideline intended for sponsors of human urine-based products, saying a standardized approach is needed to ensure that products are free from dangerous contaminants.
As regulators explain in the guideline-on the adventitious agent safety of urine-derived medicinal products-human urine is used in several products, including human chorionic gonadoptropin (hCG), human menopausal gonadotropin or menotropin (HMG) and follicle-stimulating hormone (FSH) and urokinase products used for thrombolysis.
Contrary to popular belief, however, urine is not inherently sterile. It can be contaminated with viruses found in the urinary tract, as well as protein-based diseases like variant Creutzfeldt-Jakob disease (vCJD). Accordingly, urine-based products must be processed to clear them of potential viral or disease-causing contaminants.
EMA's draft guidance takes a risk-based approach similar in concept to blood donation guidelines. First, companies should ensure that donors are screened using appropriate exclusion criteria to the extent possible. The selection of donors will depend on the product being produced, as some are derived from a very small group of patients, while others (i.e. urokinase) may be manufactured from larger donor pools.
Second, manufacturers are encouraged to process urine products in such a way as to inactivate or remove contaminants from the product. These capabilities should be backed by data supporting defined steps in the manufacturing process. Regulators cited pasteurization or nanofiltration as possible methods.
Regulators recommend screening for a wide range of specific viruses, including those found directly in the urine, but also in fecal matter as well.
Finally, EMA said manufacturers need to perform risk assessments for the overall transmission risks associated with urine-derived medicinal products, saying that some procedures for collecting urine may be less safe than others.
Among the factors to consider are the viral epidemiology of the region around the collection location (i.e. geographical location), donor selection criteria, the use of pooling, hygiene procedures and purification methodologies.
Comments on the Guideline will be accepted until 31 May 2014.
Tags: Urine, Draft Guideline, Latest News, EU
Regulatory Focus newsletters
All the biggest regulatory news and happenings.