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.
Resources, news and special offers to support you and your professional development during this difficult time.
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.
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.
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 25 April 2013 | By Louise Zornoza,
Under a new plan announced by Brazil's regulatory agency, Anvisa, even if Brazil fails to obtain EU recognition for its active pharmaceutical ingredient (API) good manufacturing practice (GMP) standards by the mandatory date of 2 July 2013, regulators will still provide Brazilian companies with a document indicating GMP compliance so facilitate exports of their APIs.
The Falsified Medicines Directive (Directive 2011/62/EU) was adopted in May 2011 to safeguard public health in the EU by protecting the pharmaceutical supply chain from infiltration by falsified (or counterfeit) medicines and introduced new rules to more rigorously regulate the supply chain.
According to the Directive, written confirmation of GMP compliance for exports of API to the EU will be required as of 2 July 2013 from countries that are not listed as having equivalent GMPs. Anvisa submitted a formal request to the EU in October 2012 to be part of that list and the European Commission is still assessing that request.
Brazilian companies that have valid GMP certificates will need to submit a petition to Anvisa using "CERTIFICATE-7239," the regulator said.
Read all Breaking News from RegLink
Europa altera requisitos para importação de insumos farmacêuticos
Tags: South America, Export, brazil, API, EU
Regulatory Focus newsletters
All the biggest regulatory news and happenings.