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.
The RAPS store will be under maintenance Saturday, 17 April between 5 AM and 12 PM EST. Store functionality may be unavailable at times during this window. We apologize for any inconvenience caused during this time.
Posted 23 June 2017 | By Michael Mezher
The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) on Friday recommended eight new medicines for approval, including two pan-genotypic hepatitis C (HCV) drugs and a third biosimilar for AbbVie's Humira (adalimumab).
EMA says that both HCV drugs, AbbVie's Maviret (glecaprevir/pibrentasvir) and Gilead's Vosevi (sofosbuvir/velpatasvir/voxilaprevir), were given a speedy review under the agency's accelerated assessment mechanism.
Both drugs are currently being reviewed by the US Food and Drug Administration. In February, AbbVie announced that its glecaprevir/pibrentasvir combination was granted a priority review by the agency, and Reuters is reporting that a decision is expected for Gilead's combination by 8 August 2017.
EMA also recommended Samsung Bioepis' Humira biosimilar candidate Imraldi, which will be commercialized in the EU by Biogen. The announcement comes just five months after the agency recommended two Humira biosimilars developed by Amgen.
In addition, EMA recommended two cancer medicines, Novartis' breast cancer drug Kisqali (ribociclib) and EUSA Pharma's renal cell carcinoma drug Fotivda (tivozanib), and German Merck's multiple sclerosis drug Mavenclad (cladribine). The agency also recommended Mylan's generic version of Bristol-Myers Squibb and Gilead's HIV drug Atripla (efavirenz/emtricitabine/tenofovir) and MendeliKABS' generic version of Swedish Orphan Biovitrum International's Orfadin (nitisinone).
EMA also updated on its Article 31 review of Symbioflor 2, a probiotic drug containing Escherichia coli (E.coli) that is currently authorized in Germany, Hungary and Austria and has been used to treat irritable bowel syndrome (IBS) and other functional gastrointestinal disorders since the 1950s.
The review was requested by the German regulator BfArM out of concern that the drug's effectiveness had not been adequately proven.
According to EMA, Symbioflor 2 can still be used to treat IBS in adults, but should not be used to treat other gastrointestinal disorders. However, the agency says the evidence supporting Symbioflor 2 has "weaknesses" and the drug has not been proven effective in children.
The agency also says it has requested the product's manufacturer, SymbioPharm GmbH to conduct a "well-designed" study on the drug in across patients with different IBS symptoms as a condition for maintaining marketing authorization.
EMA
Tags: CHMP, Maviret, Vosevi, Imraldi
Regulatory Focus newsletters
All the biggest regulatory news and happenings.