The RAC (Regulatory Affairs Certification) credential from RAPS (Regulatory Affairs Professionals Society) is the gold standard for professionals working in medical device, pharmaceutical, and biotechnology regulatory affairs. Passing the RAC exam demonstrates mastery of complex global regulatory frameworks — from FDA submission pathways to EU MDR compliance and ICH guidelines — making it one of the most valued credentials in the life sciences industry.
This free RAC practice test PDF gives you printable exam questions covering all major RAC exam domains. Download it to study on your commute, review during breaks, or run paper-based drills with colleagues. Each question reflects the style and difficulty level of the actual RAPS exam.
The RAC exam tests your ability to apply regulatory knowledge to real-world scenarios involving drugs, biologics, medical devices, and diagnostics. Questions are scenario-based and require understanding not just what regulations say, but how to apply them across different product types and geographic markets.
A significant portion of the exam covers FDA processes: 510(k) clearance and substantial equivalence arguments for medical devices, Pre-Market Approval (PMA) for high-risk devices, De Novo classification requests, Biologics License Applications (BLA), New Drug Applications (NDA), and Abbreviated New Drug Applications (ANDA) for generic drugs. You must understand the evidentiary standards and documentation requirements for each pathway.
Questions on the EU track cover CE marking requirements, the Medical Device Regulation (MDR 2017/745) and In Vitro Diagnostic Regulation (IVDR 2017/746), Notified Body roles, technical documentation requirements, and the European Medicines Agency (EMA) centralized procedure for drug authorizations.
The International Council for Harmonisation (ICH) guidelines are heavily tested. You need command of the Q series (pharmaceutical quality), S series (nonclinical safety), E series (clinical efficacy and safety), and M series (multidisciplinary topics including eCTD format). Understanding how ICH guidelines are implemented differently across FDA and EMA is a key exam skill.
This domain covers IND application requirements, Good Clinical Practice (GCP) standards, IRB/IEC oversight, 21 CFR Part 312 compliance, adverse event reporting timelines (MedWatch, MDR reports), and the distinction between expedited and periodic safety reports. Post-market surveillance planning for both drugs and devices is tested in depth.
Printable PDFs are ideal for offline study, but timed online practice sharpens your test-taking skills for exam day. Our RAC practice test covers all key regulatory domains with instant scoring and detailed answer explanations. Combining the PDF with online timed sets gives you the most complete preparation for this challenging three-hour certification exam.
Try these questions from our free Regulatory Affairs Certification practice tests. The correct answer and an explanation follow each question.
Which ICH guideline specifically addresses the stability testing of new drug substances and products?
Answer: C. ICH Q1A(R2)
ICH Q1A(R2) provides guidance on stability testing conditions, protocols, and data interpretation for new drug substances and products.
A company seeks approval in both the EU and US simultaneously. The primary benefit of using the ICH CTD format is:
Answer: B. It provides a harmonized submission structure accepted by both FDA and EMA
The ICH CTD (Common Technical Document) provides a standardized format accepted by FDA, EMA, and other ICH member agencies, reducing duplication in preparing dossiers.
What is the regulatory basis for requiring expiration dates on pharmaceutical products in the US?
Answer: B. 21 CFR 211.137
21 CFR 211.137 requires expiration dating based on stability testing to ensure drug products meet specifications through their labeled shelf life.
When creating a strategic regulatory plan, the process of gathering and analyzing publicly available information on competitor products, regulatory agency decisions, and new guidance documents is known as:
Answer: C. Regulatory intelligence
Regulatory intelligence is the process of gathering and analyzing publicly available regulatory, scientific, and legal information to inform a company's regulatory strategy. This activity helps a company understand the current regulatory landscape, anticipate changes, learn from competitors' experiences, and make more informed strategic decisions throughout the product lifecycle.
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