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.
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.
Join the brightest minds in regulatory at the annual Regulatory Convergence. See the global regulatory community in action. Intensive workshops. Topical sessions. Meet ups with regulators. This is where it all comes together.
For 20 years, our flagship publication, Fundamentals of US Regulatory Affairs, has been giving regulatory professionals the insights and answers they need, right at their fingertips.
There are hundreds of RAC testing centers available worldwide. Any of the four RAC exams (US, EU, CAN or Global) may be taken at any location. Find an upcoming exam at a location near you.
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 08 June 2016 | By Zachary Brennan
China’s Food and Drug Administration (CFDA) in 2015 inspected less than half the number of pharmaceutical manufacturers as compared with 2014, according to a recently released annual report from the Center for Food and Drug Inspection of CFDA.
The report claims that as the number of domestic inspections has decreased significantly, “the proportion of enterprises going through rectification inspection and receiving Warning Letters has significantly increased, with the ratio of rectification inspection reaching 13%.”
The Chinese regulator said it’s increasingly finding critical deficiencies with data integrity, including data manipulation, and untraceability of data and production behavior.
For 2015, CFDA conducted 221 inspections for pharmaceutical good manufacturing practice (GMP) certification, of which 212 passed and 9 (4%) failed, while 68 enterprises received warning letters.
By comparison, CFDA conducted 584 GMP inspections in 2013 (and issued 104 warning letters) and in 2014, conducted 482 inspections and sent 146 warning letters.
According to the agency’s statistical analysis, the most deficiencies cited in warning letters were linked to quality control and assurance, documentation management, equipment and qualification and verification.
Staff training was also a major issue for companies, as the most frequently cited deficiency clause was: “All personnel related to pharmaceutical production and quality shall be provided with relevant training, of which the content shall meet the requirements of the post.”
Center for Food and Drug Inspection of CFDA Annual Report on Drug Inspection (2015)
Tags: Chinese drug inspections, CFDA inspections, GMP violations in China
Regulatory Focus newsletters
All the biggest regulatory news and happenings.