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 20 February 2013 | By Louise Zornoza,
China's State Food and Drug Administration (SFDA) has announced the release of the revised pharmaceutical Good Supply (Distribution) Practices (GSP) slated to take effect on 1 June 1 2013, with a three-year transition period for the implementation by companies of the mandated quality control system.
Drug makers who fail to meet the amended GSP standards by 2016 will not be allowed to continue operations, regulators said.
This is the first major revision of the GSPs in more than a decade, and according to SFDA the revisions draw on those of the "World Health Organization (WHO), and the regulatory policies of the United States, the European Union and other developed countries and regions."
The revisions include the obligation to implement a quality control system with an electronic drug monitoring system, bar codes to ensure pharmaceutical traceability, use of standardized documentation and information technology, and ensuring that responsible persons are properly qualified.
A draft version of the revised GSPs was made available for comment on 25 April 2012.
Read all Breaking News from RegLink
Tags: GDP, SFDA
Regulatory Focus newsletters
All the biggest regulatory news and happenings.