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 13 June 2014 | By Alexander Gaffney, RAC,
The US Food and Drug Administration (FDA) has adopted and released a new guidance document intended to clarify the International Conference on Harmonisation's (ICH) Q4B guideline on the use of pharmacopoeial texts.
ICH is a regional harmonization group composed of the US, EU and Japan, as well as other countries which serve in a voluntary capacity.
The aim of the group is to allow the regulatory processes of each to better align with those of the others, thereby allowing greater efficiencies for industry. This is perhaps best exemplified by the common technical document, which permits a company to submit a pharmaceutical dossier to all three countries with only minimal changes to a single module of the submission format to account for minor regional differences.
That standardization process, however, goes far beyond just submission formats, extending as well to certain supporting texts, such as the regional pharmacopoeias of the ICH regions.
On 13 June 2014, FDA announced the release of an ICH document, Q4BEvaluation and Recommendation of Pharmacopoeial Texts for Use in the International Conference on Harmonisation Regions; Annex 6: Uniformity of Dosage Units General Chapter (Q4B Annex 6).
Like other Annex documents in the Q4B series, the text is intended to clarify which pharmacopoeial texts on the uniformity of dosage units are equivalent between regions, and whether conditions apply to their use in certain regions.
As the document explains, ICH has deemed three texts mostly interchangeable:
However, those texts are subject to some limitations:
FDA explained that it may request that companies demonstrate "that the chosen method is acceptable and suitable for a specific material or products, irrespective of the origin of the method," and that it will not accept the first limitation (listed above) as suitable "for regulatory purposes."
Q4BEvaluation and Recommendation of Pharmacopoeial Texts for Use in the International Conference on Harmonisation Regions; Annex 6: Uniformity of Dosage Units General Chapter (FR)
Tags: Q4B, Quality, Pharmacopoeia, Pharmacopoeial, Dosing, Dosage Units, Guidance
Regulatory Focus newsletters
All the biggest regulatory news and happenings.