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Free Practice Questions for Registered Seller Examination

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Exam pass rate: 40.7% nationally in FY2025 (MHLW, 31 Mar 2026)
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Key Facts: Registered Seller Examination Exam

120 questions / 240 min

Official written MCQ length in the MHLW implementation notice and 2026 prefectural notices

MHLW 薬食総発第0808001号; Tokyo and Saga FY2026 exam pages

~70% + chapter floor

National pass idea: about 84/120 plus a prefecture-set chapter minimum (Tokyo 35%; Hokkaido FY2026 40%)

MHLW implementation notice; Tokyo FY2025 published criteria (84/120 plus 35% per subject); Hokkaido FY2026 notice

Class 2 and Class 3 OTC

Sales scope of a registered seller under the PMD Act after 販売従事登録

MHLW 薬生発0331第16号

40.7% in FY2025

National compilation pass rate (24,004 / 58,996) as of 31 Mar 2026

MHLW 令和7年度登録販売者試験実施状況

Open eligibility to sit

No degree, age, nationality, or experience requirement from FY2015

Tokyo FY2026 Q&A; MHLW 薬生発0331第16号

Japan's 登録販売者試験 is a prefectural Japanese written MCQ: 120 items, 240 minutes, about 70% overall plus a chapter floor. FY2026 fees include Tokyo 13,600 JPY and Hokkaido 18,200 JPY. This bank is independent English MCQ study, not the official Japanese papers.

Sample Registered Seller Examination Practice Questions

Try these sample questions to review concepts for the Registered Seller Examination exam. Each question includes a detailed explanation. Start the interactive quiz above for the full 100+ question experience with AI tutoring.

1Which of the following statements accurately describes the fundamental nature of pharmaceuticals (医薬品) under the MHLW curriculum guidelines?
A.Pharmaceuticals are designed to be completely free of adverse health risks when taken within standard OTC dosages.
B.Pharmaceuticals are foreign substances (異物) to the human body that inevitably possess both therapeutic efficacy and potential health risks.
C.Over-the-counter pharmaceuticals can completely cure all underlying chronic pathological diseases without requiring professional medical diagnosis.
D.The biological efficacy of a pharmaceutical substance increases indefinitely in direct proportion to the administered dose without a ceiling effect.
Explanation: According to the MHLW guidelines (Chapter 1), pharmaceuticals are inherently foreign substances (異物) introduced into the human body. Even when manufactured under strict quality standards and used correctly, they always carry potential risks alongside their therapeutic benefits, requiring careful risk-benefit evaluation and appropriate consumer guidance.
2What is the official understanding of the placebo effect (プラセボ効果) in the context of over-the-counter pharmaceutical administration?
A.It represents a genuine pharmacological response triggered by chemical constituents interacting directly with target cellular receptors.
B.It is an objective physiological or psychological improvement resulting from psychological expectation, suggestion, and the act of taking medication.
C.It is a harmful allergic hypersensitivity reaction that occurs only when an individual possesses pre-existing genetic polymorphisms.
D.It is an administrative standard used exclusively to calculate the retail price of Class 2 and Class 3 non-prescription pharmaceuticals.
Explanation: The placebo effect refers to favorable subjective or objective changes brought about not by the chemical action of active pharmaceutical ingredients, but by psychological factors such as trust in the healthcare provider or medicine, anticipation of healing, and the psychological reassurance of taking medicine. While beneficial in clinical context, treatments must never rely solely on placebo effects when real medical intervention is needed.
3According to the MHLW guidelines, which physiological factor primarily accounts for the heightened vulnerability of pediatric patients (小児) to central nervous system adverse drug reactions?
A.Excessive renal tubular secretion of water-soluble metabolites leading to rapid volume depletion.
B.Immaturity of the blood-brain barrier (血液脳関門), allowing higher concentrations of active substances to penetrate cerebral tissue.
C.Elevated levels of circulating plasma albumin causing irreversible displacement of lipophilic drugs.
D.Accelerated hepatic microsomal enzyme induction that converts prodrugs into neurotoxic isomers.
Explanation: In infants and young children, physiological protective barriers and organ functions are incompletely developed. Specifically, the blood-brain barrier (血液脳関門) is immature and more permeable, which allows pharmaceutical substances that cross the barrier poorly in adults to enter pediatric brain tissue easily, markedly increasing susceptibility to central nervous system side effects such as sedation, convulsions, or respiratory depression.
4When selling over-the-counter medications to elderly individuals (高齢者), which physiological change must registered sellers consider most carefully?
A.Marked acceleration of glomerular filtration rate (GFR) leading to subtherapeutic blood levels of active ingredients.
B.Decline in physiological reserves, including reduced hepatic metabolic capacity and diminished renal excretion function.
C.Enhanced stomach acid production that prevents standard enteric-coated tablets from dissolving in the small intestine.
D.Complete immunity against adverse anticholinergic effects such as urinary retention and dry mouth.
Explanation: The MHLW guidelines treat elderly users as having reduced physiological reserve, especially slower hepatic metabolism and reduced renal excretion. Standard adult doses therefore remain in the body longer and raise the risk and severity of adverse reactions, so sellers should check concurrent medicines and recommend medical advice when function is likely impaired.
5Regarding the administration of pharmaceuticals during pregnancy and lactation, which statement accurately reflects the principles in the MHLW examination guidelines?
A.Active drug substances are entirely blocked by the placental barrier and cannot reach the developing fetus.
B.Many active pharmaceutical substances can cross the placental barrier and transfer into breast milk, requiring conservative use and medical consultation.
C.All over-the-counter medications are certified completely teratogen-free and can be used without restriction during the first trimester.
D.Lactating mothers may safely take any OTC sedative as long as the medication is administered immediately before breastfeeding.
Explanation: The placental barrier (胎盤関門) is not an absolute filter; numerous chemical compounds, active drug metabolites, and lipophilic substances cross into the fetal circulation, potentially causing teratogenic defects (particularly during organogenesis in early pregnancy) or neonatal depression. Furthermore, many substances transfer into breast milk, directly exposing nursing infants to pharmacological effects. Therefore, pregnant and lactating women must exercise extreme caution and seek physician consultation before taking OTC drugs.
6Which mechanism distinguishes an allergic adverse drug reaction (アレルギー反応) from a general pharmacodynamic side effect?
A.Allergic reactions always depend strictly on exceeding the maximum recommended chemical dosage.
B.Allergic reactions are mediated by immunological mechanisms and can be triggered even by minute trace quantities in sensitized individuals.
C.Allergic reactions occur only during the first administration of a substance in an individual with no prior immune exposure.
D.Allergic reactions are confined exclusively to gastrointestinal tract irritation and cannot cause cutaneous manifestations.
Explanation: Allergic drug reactions (hypersensitivity) involve immune-mediated responses where the immune system, having been previously sensitized (感作) to a drug or its hapten-protein complex, mounts an antibody- or cell-mediated attack. Consequently, even minute doses well below therapeutic thresholds can provoke severe reactions (such as urticaria, bronchospasm, or anaphylaxis), independent of the dose-response relationship governing direct pharmacodynamic toxicities.
7A customer who regularly consumes grapefruit juice asks about potential interactions with oral medications. What is the pharmacological basis for the interaction between grapefruit juice and certain pharmaceuticals?
A.Grapefruit juice accelerates renal tubular secretion, causing rapid elimination of active compounds.
B.Components in grapefruit juice (such as furanocoumarins) inhibit intestinal cytochrome P450 3A4 (CYP3A4), leading to elevated drug bioavailability and toxicity risk.
C.Grapefruit juice permanently neutralizes gastric acid, preventing enteric-coated tablets from disintegrating in the intestine.
D.Grapefruit juice chelates active drug molecules into insoluble calcium complexes that are completely excreted in the feces.
Explanation: Grapefruit juice contains furanocoumarin compounds that inhibit the metabolic enzyme cytochrome P450 3A4 (CYP3A4) in the small intestinal wall. For orally administered drugs that normally undergo substantial first-pass metabolism by CYP3A4 (such as certain calcium channel blockers and sedatives), this inhibition dramatically increases systemic absorption and blood concentrations, magnifying therapeutic actions and toxic side effects.
8Under Japanese health food regulations and MHLW guidelines, which statement correctly distinguishes Foods for Specified Health Uses (特定保健用食品 / Tokuho) from Foods with Nutrient Function Claims (栄養機能食品)?
A.Tokuho products require individual government assessment and approval for efficacy and safety, whereas Foods with Nutrient Function Claims rely on self-certification standards.
B.Foods with Nutrient Function Claims require individual pre-market clinical trials approved by the Minister of Health, Labour and Welfare.
C.Tokuho products can make therapeutic claims curing specific acute infectious diseases such as influenza and pneumonia.
D.Both Tokuho and Foods with Nutrient Function Claims are legally classified as prescription pharmaceutical drugs.
Explanation: Foods for Specified Health Uses (特定保健用食品 / Tokuho) require individual scientific evaluation and pre-market approval by the Consumer Affairs Agency (in consultation with MHLW and the Food Safety Commission) to display specific physiological effects. In contrast, Foods with Nutrient Function Claims (栄養機能食品) follow a self-certification system (自己認証制度) based on established governmental nutrient benchmark standards without requiring individual pre-market screening.
9When a customer presents at a drugstore seeking OTC medications for persistent symptoms, in which situation is it most critical for the registered seller to recommend immediate medical consultation (受診勧奨) rather than selling an OTC product?
A.The customer experiences mild nasal congestion after exposure to cold outdoor air for twenty minutes.
B.The customer reports sudden severe chest pain, shortness of breath, and radiating left shoulder pain.
C.The customer requests a topical moisturiser to treat mild skin dryness on their forearms in winter.
D.The customer is looking for a vitamin C supplement to take alongside a balanced daily diet.
Explanation: Medical consultation recommendation (受診勧奨 / Jushin Kansho) is a fundamental professional duty of the registered seller. When customers exhibit red-flag symptoms such as severe sudden chest pain, dyspnea, and radiating pain—which strongly suggest acute coronary syndromes or other life-threatening medical emergencies—OTC self-medication is entirely inappropriate and immediate medical evaluation must be prioritized.
10What is the proper interpretation of the expiration date (使用期限) indicated on an over-the-counter pharmaceutical package?
A.It represents the date after which the medication can be safely taken indefinitely if stored in a domestic refrigerator.
B.It indicates the period during which quality, safety, and efficacy are guaranteed when stored unopened under prescribed conditions.
C.It guarantees that an opened bottle of liquid syrup remains sterile and chemically stable for at least three additional years.
D.It is a voluntary marketing recommendation that retail stores can extend at their discretion after visual inspection.
Explanation: The expiration date printed on an OTC pharmaceutical package guarantees the quality, potency, and safety of the product up to that date, provided the container remains unopened and stored in accordance with specified conditions (e.g., cool, dry place, protected from direct sunlight). Once opened, exposure to atmospheric oxygen, moisture, and microbial contamination significantly reduces stability, and the product should be used promptly regardless of the printed unopened expiration date.

About the Registered Seller Examination Exam

The Registered Seller Examination (登録販売者試験) is Japan's qualifying exam for non-pharmacist sellers of Class 2 and Class 3 OTC medicines under the Pharmaceuticals and Medical Devices Act (薬機法) Art. 36-8. Prefectural governors administer it at least once a year using MHLW's Guidelines for Creating Examination Questions (令和8年4月一部改訂). It is a Japanese written multiple-choice paper of 120 items in five chapters (20, 20, 40, 20, 20) over 240 minutes. The national pass standard is about 70% overall plus a chapter floor set by each prefecture. From FY2015 there is no education or experience requirement to sit. A pass is recognized nationwide, but selling still requires 販売従事登録 in the prefecture of employment. OpenExamPrep publishes independent English multiple-choice study covering the five guideline chapters. It is not an official translation, not a prefectural paper, and not a substitute for the Japanese exam.

Exam sponsor: Prefectural governors under MHLW curriculum standards (厚生労働省 試験問題の作成に関する手引き). The requirements and fees below concern the certification or admission exam, separate from our free practice resources.

Assessment

Prefectural written multiple-choice exam in Japanese under PMD Act Art. 36-8. MHLW's 手引き (令和8年4月) is the national scope. 120 items over 240 minutes, typically two 120-minute sessions of 60 questions; Tokyo FY2026 puts Chapters 1, 2 and 4 in the morning and Chapters 3 and 5 in the afternoon. Pass: about 70% overall plus a prefecture-set chapter floor.

Time Limit

240 minutes (typically two 120-minute sessions of 60 questions each)

Passing Score

About 70% overall plus a prefecture-set chapter floor (Tokyo has used 84/120 and 35% per chapter; Hokkaido FY2026 publishes 70% and 40% per chapter)

Exam / Certification Fees

Prefectural ordinance. FY2026 examples: Kansai Wide Area Union 12,800 JPY; Tokyo 13,600 JPY; Saga 13,000 JPY; Hokkaido 18,200 JPY

Exam sponsor website

Reported exam pass rate: 40.7% nationally in FY2025 (MHLW, 31 Mar 2026). MHLW compilation of prefectural results, counting people who sat more than one prefecture once per sitting. FY2024 was 46.7%. Prefectural rates in FY2025 ranged from 23.2% (Okinawa) to 54.8% (Hokkaido). This describes exam candidates, not OpenExamPrep users or results from using our resources. Exam sponsor website

Fees, eligibility, and exam policies can change. Confirm them with the exam sponsor before applying or paying.

Our practice resources: topics covered

We aim to reflect publicly available exam outlines and topic information in our study resources. Coverage, format, and difficulty may differ from the actual exam, and we cannot guarantee that every detail is accurate or current. Confirm exam requirements, fees, and policies with the official exam sponsor.

17% of this local practice set

第1章：医薬品に共通する特性と基本的な知識 (Characteristics and basic knowledge common to pharmaceuticals)

Risk-benefit of pharmaceuticals, adverse reactions, special populations, placebo, interactions, quality, self-medication, and historical 薬害 cases.

17% of this local practice set

第2章：人体の働きと医薬品 (Human body functions and pharmaceuticals)

Digestive, respiratory, circulatory, nervous, urinary, and sensory systems; ADME; dosage forms; severe adverse reactions (SJS, TEN, liver injury).

33% of this local practice set

第3章：主な医薬品とその作用 (Major pharmaceuticals and their actions)

Active ingredients, indications, contraindications, and interactions for OTC cold, analgesic, GI, dermatological, ophthalmic, Kampo, and disinfectant products.

17% of this local practice set

第4章：薬事に関する法規と制度 (Pharmaceutical laws and systems)

PMD Act, OTC classes, 要指導医薬品, 指定濫用防止医薬品 (from 1 May 2026), registered-seller registration, store licensing, and advertising rules.

16% of this local practice set

第5章：医薬品の適正使用と安全対策 (Proper use of pharmaceuticals and safety measures)

Package-insert 'Do Not' and 'Consult' sections, PMDA Yellow/Blue Letters, Art. 68-10 ADR reporting, and the Adverse Drug Reaction Relief System.

Preparing for the Registered Seller Examination Exam

What You Need to Know

  • Passing score: About 70% overall plus a prefecture-set chapter floor (Tokyo has used 84/120 and 35% per chapter; Hokkaido FY2026 publishes 70% and 40% per chapter)
  • Assessment: Prefectural written multiple-choice exam in Japanese under PMD Act Art. 36-8. MHLW's 手引き (令和8年4月) is the national scope. 120 items over 240 minutes, typically two 120-minute sessions of 60 questions; Tokyo FY2026 puts Chapters 1, 2 and 4 in the morning and Chapters 3 and 5 in the afternoon. Pass: about 70% overall plus a prefecture-set chapter floor.
  • Time limit: 240 minutes (typically two 120-minute sessions of 60 questions each)
  • Exam / certification fees: Prefectural ordinance. FY2026 examples: Kansai Wide Area Union 12,800 JPY; Tokyo 13,600 JPY; Saga 13,000 JPY; Hokkaido 18,200 JPY Official sources

Using Our Practice Resources

  • Work through all 100 available questions
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Registered Seller Examination: Suggested Study Strategy

1Give Chapter 3 extra time: it is 40 of 120 official items (one-third of the paper) and drives most ingredient, contraindication, and Kampo recall.
2Protect every chapter floor. A high Chapter 3 score cannot rescue a fail if any chapter is below the prefecture's 35% or 40% cut.
3Learn driving and machinery bans on first-generation antihistamines, codeine derivatives, scopolia extract, and other anticholinergic ingredients in the 'Do Not' (してはいけないこと) box.
4For Chapter 5, know the Relief System exclusions that actually apply to OTC sales — improper use, damage mild enough not to need hospital-level care, insecticides/rodenticides and disinfectants not applied directly to the body, in-vitro test kits, and Pharmacopoeia items such as purified water and petrolatum — and that healthcare-professional ADR reports under Art. 68-10(2) go to PMDA with no fixed statutory deadline.
5For 2026 sittings, study 指定濫用防止医薬品 rules in force from 1 May 2026: no large-volume or multiple packs for purchasers under 18, and pharmacist or registered-seller confirmation/information duties.

Frequently Asked Questions

Who administers the Registered Seller Examination in Japan?

Each prefectural governor administers it at least once a year. Shiga, Kyoto, Osaka, Hyogo, Nara, and Wakayama sit a common Kansai Wide Area Union paper. All sittings use MHLW's Guidelines for Creating Registered Seller Examination Questions (令和8年4月).

What is the passing score?

MHLW's 2007 implementation notice, still cited for method (except old eligibility), tells prefectures to pass candidates with about 70% overall and a governor-set floor in each chapter. Tokyo has published 84/120 plus 35% per chapter. Hokkaido's FY2026 notice publishes 70% overall and 40% per chapter.

What medicines can a registered seller sell?

After 販売従事登録, a registered seller may sell Class 2 (including Designated Class 2) and Class 3 OTC medicines. Class 1 OTC drugs and 要指導医薬品 require a pharmacist. Store-manager status needs additional qualifying experience.

Are there eligibility restrictions to sit?

No. Tokyo's FY2026 Q&A and MHLW's handling notice state that the former education and practical-experience sit requirements ended in FY2015. Anyone may apply in any prefecture.

Is a pass only valid in the prefecture where you sat?

No. Tokyo's FY2026 Q&A states that a pass remains valid even if you later work in another prefecture. You still file 販売従事登録 where you will work; the Kansai union does not itself issue that registration.

Is this practice question bank an official examination resource?

No. OpenExamPrep publishes independent English-language multiple-choice study covering topics in the MHLW 手引き. Official papers are Japanese written MCQs administered by prefectures. This set is not an official translation, not a format simulation of any prefecture's booklet, and not a substitute for Japanese exam materials.