RAPS RAC Regulatory Affairs Certification RAC-GS

Certification exams change, and Getcertkey keeps pace: the RAC-GS practice question set is reviewed continuously and updated free of charge for 365 days. Your RAPS Regulatory Affairs Certification (RAC) Global Scope preparation stays aligned with the current exam throughout 2026 and beyond.

RAPS RAC-GS Exam Overview:

Certification Vendor:	Regulatory Affairs Professionals Society (RAPS)
Exam Name:	Regulatory Affairs Certification (RAC) Global Scope
Exam Number:	RAC-GS
Passing Score:	Scaled pass score set by RAPS (official pass mark not publicly published)
Exam Price:	Fees vary by testing window and membership status (typically higher for non-members)
Exam Format:	Multiple choice, Computer-based
Real Exam Qty:	Approx. 180 (divided into two parts)
Exam Duration:	Approx. 210 (3.5 hours)
Related Certifications:	RAC-Devices RAC-Drugs
Available Languages:	English
Sample Questions:
Exam Way:	Computer-based testing at Pearson VUE centers or online proctored
Pre Condition:	Typically at least three years of regulatory affairs or related professional experience; specific prerequisites are determined by RAPS
Official Syllabus URL:	https://www.raps.org/certifications/rac/what-is-the-rac

RAPS RAC-GS Exam Syllabus Topics:

RAC-GS Exam FAQs for 2026 Candidates

Which certification does the RAC-GS exam lead to?

The RAC-GS exam is the official Regulatory Affairs Professionals Society (RAPS) exam behind the RAC Regulatory Affairs Certification certification, validating the skills measured by the RAPS Regulatory Affairs Certification (RAC) Global Scope credential. It sits at the Professional level of the Regulatory Affairs Professionals Society (RAPS) certification program. It also connects to RAC-Drugs, RAC-Devices, so the knowledge you build here carries over to those tracks as well.

How many questions are on the RAC-GS exam, and how much time do I get?

The RAC-GS exam contains Approx. 180 (divided into two parts) questions to be completed within Approx. 210 (3.5 hours). Before exam day, divide the available time by the question count to work out a comfortable per-question pace, and mark any item that eats into it so you can return later instead of getting stuck. Timed sessions in the Getcertkey test engines make that pacing automatic — run at least two full-length mock exams under the clock so time pressure never becomes the reason you drop points.

What score do I need to pass the RAC-GS exam, and what does it cost?

The passing score for the RAC-GS exam is Scaled pass score set by RAPS (official pass mark not publicly published), and the official registration fee is Fees vary by testing window and membership status (typically higher for non-members). Retakes are not discounted — every new attempt means paying the full fee again — so it pays to measure yourself before you book. Work through the 100 practice questions on Getcertkey, sit a timed practice test, and schedule your exam only when your scores are consistently comfortable. That simple habit is the cheapest exam strategy there is.

Are there any prerequisites for the RAC-GS exam?

Typically at least three years of regulatory affairs or related professional experience; specific prerequisites are determined by RAPS Requirements can change when Regulatory Affairs Professionals Society (RAPS) revises its certification program, so confirm the current eligibility rules on the official exam page before you register.

Can I try the RAC-GS practice questions before I buy?

Yes. Getcertkey provides a free RAC-GS PDF demo so you can review the question style and answer quality before purchasing. Every purchase also includes 365 days of free updates — if RAPS revises the exam during that period, the updated material reaches you at no cost. Once the free-update year ends, you can extend your update service at a 50% discount.

What if I fail the RAC-GS exam, and how is my order delivered?

Every RAPS Regulatory Affairs Certification (RAC) Global Scope purchase on Getcertkey is covered by a 100% money-back guarantee with clear conditions: if you take the corresponding exam within 60 days of your purchase and do not pass, you can claim a full refund by submitting a scanned copy of your exam enrollment slip and your official score report as a PDF within two days of the exam date; claims are processed within seven days of submission. The guarantee does not apply to exams taken within three days of purchase, to material that was downloaded but never used in an exam attempt, or to free products and expired orders, and the candidate name must match the payer name. If you would rather not take a refund, you can instead exchange your purchase for two free exam preparation products of equal value and keep the update service on your original product.

Delivery is instant: your download is sent to your email within one minute of payment, with no limit on how many computers you may install the material on. If nothing arrives within two hours, check your spam folder and contact customer service for help.

What topics are covered in the RAC-GS exam?

The RAPS Regulatory Affairs Certification (RAC) Global Scope exam blueprint is organized into 4 domains. The first three are:

• Regulatory Strategy and Submissions
• Product Lifecycle Management
• Global Regulatory Environment

For the complete domain-by-domain breakdown, scroll up to the full exam topics outline above and use it to plan how you distribute your study time.

RAPS Regulatory Affairs Certification (RAC) Global Scope Sample Questions:

Question #1
As a member of the product launch review committee, a regulatory affairs professional discovers a major issue with the labeling of a product prior to production. In addition to informing the committee, which is the BEST approach to address the issue?

A. Delay the start of product production.
B. Abort the product launch.
C. Inform the regulatory authorities.
D. Correct the label text.

Question #2
A superiority advertising claim for a product versus its competitor's product can only be made under which of the following circumstances?

A. Results of a three-year, post-market patient survey indicate the product is superior.
B. In vitro studies show the product to be superior.
C. Government survey data indicate the product is superior.
D. Results of adequate, well-controlled comparative clinical trial show the product is superior.

Question #3
According to WHO,what are the temperature and humidity conditions for a Zone IVb long-term stability study?

A. 30c C and 65% RH
B. 25: C and 60% RH
C. 30c C and 35% RH
D. 30: C and 75% RH

Question #4
A global company has obtained a patent in a specific country for a newly marketed product. What would be the BEST advice In order to protect the patent in other countries?

A. Use the community patent system.
B. File design patents in target countries.
C. Use the Madrid system.
D. File patents of interest in target countries.

Question #5
What is the LAST stage in the development of a quality risk management process for a medical device?

A. Risk analysis
B. Risk acceptance
C. Risk evaluation
D. Risk reduction

Solutions: