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RAC: Up. It's where you'll go.

Regulatory Affairs Certification (RAC)

Earning and maintaining your RAC shows that you have made a commitment to being a highly skilled and knowledgeable regulatory professional, throughout the span of your career. That’s a commitment employers and clients like to see.

» Registration for the RAC 2014 autumn cycles is open now.

The Regulatory Affairs Certification Board (RACB) has approved a number of changes to the policies governing Regulatory Affairs Certification (RAC) that went into effect in 2014. The changes affect both those taking an RAC exam for certification and those who have already been certified and wish to maintain their RAC credential in good standing.

» Visit Under RAPS for more information on the changes.

 About the RACs

The Regulatory Affairs Certification (RAC) is the only globally recognized professional credential for those involved with the regulation of healthcare products. The RAC exam tests your regulatory knowledge, as well as your critical thinking ability, in four areas of regulatory practice.

RAC professionals are today’s leaders—setting the bar high for industry knowledge, dynamic critical thinking ability and a commitment to ongoing education.

A RAC is obtained by passing a rigorous exam and maintained by acquiring continuing education credits within a three-year cycle.

Four certifications are available:

  • RAC (US): Knowledge of US regulations
  • RAC (EU): Knowledge of European Union regulations
  • RAC (CAN): Knowledge of Canadian regulations
  • RAC (Global): Knowledge and critical thinking skills related to the general scope of practice of regulatory professionals throughout the product lifecycle, with reference to global standards from ICH, GHTF (through IMDRF), WHO and ISO.

Our online RAC self-assessment survey will help you evaluate your areas of expertise and growth to assist in choosing the right RAC for you, and our practice and simulation exams will help you take the next steps in evaluating your readiness in taking the RAC exam.


RAC professionals are today’s regulatory leaders, working in all parts of the world and in many settings, including industry, government, consultancies and academia.

Earning your RAC offers both you and your employer many tangible benefits. Adding the RAC title to your name signifies your proficient knowledge, commitment to excellence and pursuit of ongoing education.

The benefits:

You Your Employer
Evidence of proficiency and critical thinking Assurance of employee proficiency by independent testing organization
Demonstrated professional and personal accomplishment Ongoing professional development
Continuous improvement and new skill development (maintaining your RAC) Elevated staff competence
Career advancement and longevity Knowledge sharing among staff
Stand out from crowd with greater earning potential – RAC holders earn 10 percent higher in salaries than those without, on average. Fill team with the top regulatory talent
 Exam Preparation

Preparing for the RAC requires intensive study as well as a personal commitment to acquire and maintain the credential. RAPS offers a variety of study materials and communities to help you develop a successful plan to pass your exam. To get started, view our free on-demand webcasts to learn useful tips: Developing a RAC Study Plan and Preparing for the RAC Examination– Strategy and Tips.

Then, view our list of resources built especially for each exam, such as study materials, practice exams, community support groups and much more.

 Getting Started

RAPS is here to help you every step of the way as you make the effort to become RAC certified. If at any point you have questions or need guidance please contact us directly at or call +1 301 770 2920.

Exam Offerings and Location

RAC exams are administrated twice a year, in the spring and autumn. Once you are registered for the RAC exam, you will receive information on how to choose your exam location. View the complete schedule for options.


View the eligibility requirements first, then register online or via fax.

Application Fee

  • RAPS members: $425 
  • Nonmembers: $525

For more detailed information on the RACs, please view the RAPS Candidate Guide.

Certification Vs. Certificate

The RAC is a professional certification: A formal recognition by an established and credible professional organization that an individual has demonstrated proficiency within, and comprehension of, an identified body of knowledge.

To earn a RAC, you must demonstrate competency by passing an exam, administrated by an accredited third-party testing provider. Neither the RAC Program nor RAPS requires you to take specific training courses as a condition of awarding the RAC credential; it is based solely on your exam performance.

What the RAC is not – A RAC is not a certificate, a document awarded for the attainment or completion of a series of courses or verification of attendance or participation in a learning event. Certificates do not have ongoing maintenance or renewal requirements and a certificate is not a precursor to certification.

The RAC Program is guided by the Regulatory Affairs Certification Board (RACB) and independent exam committees.

Download RAC Autumn Candidate Guide
Certification vs. Credential
Contact RAPS about the RAC