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.
With so many global regulation changes, staying informed is a challenge. Join other regulatory professionals as you navigate the gray 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. Either RAC exam (Devices and Drugs) 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 23 February 2015 | By Michael Mezher
The European Medicines Agency (EMA) has announced it is putting together a task force to oversee the implementation of new standards for identifying drugs.
The goal of the task force will be to develop a roadmap for EU-wide implementation of identification of medicinal products (IDMP) standards developed by the International Organization for Standardization (ISO).
EMA recently issued an explanatory document titled Data submission of authorised medicines in the European Union. The document outlined the data submission requirements for medicinal products under Article 57 of Regulation (EC) No. 726/2004, and provided information to companies on the scope and format of the data to be submitted.
For more information about data submission requirements under see our article “EMA Explains Centralized Product Database, Talks Future Changes”
In the document, EMA says that it is looking to replace its current eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) with IDMP standards. The move is also made to comply with Articles 25 and 26 of Commission Implementing Regulation (EU) No. 520/2012 which “require the use of common standards, formats and terminologies for the identification and exchange of information on medicines.”
Regulation (EU) No. 520/2012 specifically states that member states, EMA and marketing authorization holders must apply terminology from the following ISO standards: 11615:2012, 11616:2012, 11238:2012, 11239:2012 and 11240:2012.
EMA is calling for interested parties to apply to participate in the EU ISO IDMP Task Force. The task force will be made up of representatives from EMA, national competent authorities and pharmaceutical industry association members. The agency is also looking for task force members who develop medicinal product dictionaries and databases, as well as other parties with expertise in the field.
The task force will be responsible for developing a roadmap that will include “a gap analysis comparing XEVMPD and ISO IDMP” and a plan to migrate data from XEVMPD to ISO IDMP.
Interested parties can submit expressions of interest to the agency by 6 March 2015.
By moving to IDMP standards, EMA hopes it will be easier for regulators to exchange information and facilitate healthcare authorities’ efforts to develop electronic health records. In addition, the agency says common, internationally accepted standards for drug identification will improve the assessment of pharmacovigilance data.
EMA plans to transition to using IDMP standards in July 2016.
EMA Call for Expression of Interest
Tags: ISO, IDMP, XEVMPD
Regulatory Focus newsletters
All the biggest regulatory news and happenings.