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.
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.
Posted 19 October 2017 | By Zachary Brennan
The European Commission last week released for consultation a proposal to re-work certain elements of the EU pharmaceutical patent system and industry group Medicines for Europe is calling for the introduction of a Supplementary Protection Certificate (SPC) manufacturing waiver and for a wider definition of the research exemption.
In the EU, SPCs, which apply to innovative pharmaceutical and plant protection products and have been increasingly used since 1993, are a unique intellectual property right that can the extend the 20-year term of a patent by up to five years.
An innovator can apply for an SPC on a product’s “basic” patent within six months of obtaining marketing authorization in any EU member state.
In essence, SPCs aim to offset the loss of effective patent protection that occurs due to testing and clinical trials that products require prior to obtaining regulatory marketing approval.
The differences in SPCs across EU member states, which is related to differences in patenting as well as litigation, result in a complicated IP landscape, though there “is no clear geographic bias in the use of SPCs by the location of patent holders,” study by Margaret Kyle of Mines ParisTech says.
“Almost 44% of SPC applicants are US-based, while the EU has close to 30%, followed by Japan and Switzerland at roughly 7% and 6%, respectively,” the study says.
Meanwhile, the EC notes that so-called Bolar patent exemption or research exemption, which is only for the pharmaceutical industry, aims to speed up the market entry of generic medicines by allowing early preparatory development on generics to obtain premarket regulatory approval even if the SPC of the reference medicine is still in force.
The scope of the exemption has been updated in some EU countries to meet new pharmaceutical-related requirements, according to the EC.
The EC’s Single Market Strategy, adopted in October 2015, announced that the Commission will consult, consider and propose improvements to the patent system in Europe, notably for pharmaceutical and other industries whose products are subject to regulatory authorizations.
In particular, the strategy said this recalibration could comprise the following 3 elements:
The EC, from now until 4 January 2018, is seeking stakeholder comments, which the Commission says it will analyze before deciding whether and to what extent it should take further action.
Industry group Medicines for Europe has already put its weight behind the idea of an SPC manufacturing waiver.
Adrian van den Hoven, Director General at Medicines for Europe, noted a recent study showing "the huge benefits that the SPC Manufacturing Waiver and Bolar harmonisation offer Europe in terms of jobs, manufacturing and a lower overall medicines bill."
Public consultation on supplementary protection certificates (SPCs) and patent research exemptions
Tags: Supplementary Protection Certificate, Bolar exemption, research exemption, pharmaceutical patents
Regulatory Focus newsletters
All the biggest regulatory news and happenings.