100+ Free Licensed Pharmacist Qualification (China) Practice Questions

Prepare for the China Licensed Pharmacist Professional Qualification Examination (全国执业药师职业资格考试) exam with instant access — no signup required.

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Key Facts: Licensed Pharmacist Qualification (China) Exam

4 Subjects

National Examination Structure (Regulations, Knowledge I & II, Practice)

NMPA / MOHRSS Examination Syllabus

4-Year Rolling

Cumulative Passing Cycle for All 4 Examination Papers

China Personnel Examination Center (CPTA)

60% Passing Line

Standard Passing Benchmark (72/120 or 60/100 points per paper)

MOHRSS National Examination Passing Standards

Licensed Pharmacist

Official Statutory Professional Title Conferred (执业药师)

PRC Provisions on Licensed Pharmacist Qualification

Annual (October)

National Examination Administration Frequency

MOHRSS Examination Schedule

NMPA / ChP

Governing Regulatory Body & National Pharmacopoeia

National Medical Products Administration (国家药品监督管理局)

The China Licensed Pharmacist Qualification Examination is the mandatory national statutory license for practicing pharmacists across China. Administered jointly by NMPA and MOHRSS, candidates must pass all 4 subject papers within a 4-year rolling cycle. This bank provides 100 verified English-language practice questions with dual-language Chinese statutory and clinical terminology.

Sample Licensed Pharmacist Qualification (China) Practice Questions

Try these sample questions to test your Licensed Pharmacist Qualification (China) exam readiness. Each question includes a detailed explanation. Start the interactive quiz above for the full 100+ question experience with AI tutoring.

1Under the PRC Drug Administration Law (中华人民共和国药品管理法) and OTC classification regulations, which of the following statements correctly distinguishes Class A (甲类) from Class B (乙类) Over-the-Counter (OTC / 非处方药) drugs in China?

A.Class A OTC drugs feature a green OTC logo and may be sold by general grocery retailers holding an approval certificate.

B.Class A OTC drugs feature a red OTC logo and can only be sold in licensed retail pharmacies with a practicing pharmacist on duty.

C.Class B OTC drugs feature a red OTC logo and require a licensed physician's prescription during initial dispensing.

D.Class B OTC drugs feature a black OTC logo and are strictly restricted to inpatient institutional hospital pharmacies.

Explanation: In China, Over-the-Counter (OTC / 非处方药) drugs are classified into Class A (甲类) and Class B (乙类) based on safety and risk profiles. Class A OTC drugs are designated with a RED oval OTC logo and may only be sold in licensed retail pharmacies (药品零售企业) staffed by a licensed pharmacist (执业药师) or pharmacy technician. Class B OTC drugs are designated with a GREEN oval OTC logo, possess a higher safety margin, and can be sold by both retail pharmacies and approved commercial retail businesses (such as supermarkets and convenience stores) that have obtained the necessary distribution filing/permit.

2According to China's Good Supply Practice for Pharmaceutical Products (GSP / 药品经营质量管理规范), what are the mandatory temperature and relative humidity ranges for a pharmaceutical 'Cold Storage Warehouse' (冷藏库)?

A.Temperature 0°C to 4°C, Relative Humidity 45% to 85%

B.Temperature -10°C to -25°C, Relative Humidity 35% to 75%

C.Temperature 2°C to 8°C, Relative Humidity 35% to 75%

D.Temperature 10°C to 20°C, Relative Humidity 30% to 70%

Explanation: Under GSP (药品经营质量管理规范) statutory standards in China, warehouse storage temperature zones are strictly defined as: Normal temperature (常温库: 10°C–30°C), Cool storage (阴凉库: not exceeding 20°C / ≤20°C), Cold storage (冷藏库: 2°C–8°C), and Frozen storage (冷冻库: -10°C to -25°C). The statutory relative humidity (RH) across standard pharmaceutical storage facilities must be maintained between 35% and 75%.

3Regarding the storage, security, and dispensing management of Narcotic Drugs (麻醉药品) and Class I Psychotropic Drugs (第一类精神药品) in Chinese medical institutions, which protocol is mandated by national regulations?

A.Storage in a dedicated safe or vault equipped with a 'dual-person, double-lock' (双人双锁) system, dual-person dispensing, and dedicated account books.

B.Open shelf storage in the inpatient pharmacy with inventory reconciliation performed on a quarterly basis.

C.Single-key locked cabinet managed exclusively by the department head nurse without requiring dual signatures for withdrawals.

D.Combined open storage with general prescription drugs provided daily inventory counts match electronic billing.

Explanation: Under the Regulations on the Administration of Narcotic Drugs and Psychotropic Drugs (麻醉药品和精神药品管理条例), medical institutions and pharmaceutical distributors must store Narcotic Drugs and Class I Psychotropic Drugs in a dedicated vault or dedicated safe (专库或专柜) featuring anti-theft alarms and video surveillance. Access strictly requires 'dual-person and double-lock' (双人双锁) control, dedicated personnel management (专人负责), dedicated ledger tracking (专账管理), dedicated prescription paper (专用处方 - red margin), and dedicated registration (专册登记).

4Under Article 98 of the PRC Drug Administration Law (药品管理法第98条), which of the following circumstances is legally defined as a 'Substandard/Inferior Drug' (劣药) rather than a 'Counterfeit Drug' (假药)?

A.A pharmaceutical preparation whose ingredients do not conform to national drug standards.

B.A substance falsely claimed to be a drug or an unapproved substance passed off as a genuine drug.

C.A drug produced using active pharmaceutical ingredients (APIs) prohibited by the NMPA.

D.A drug whose expiration date (有效期) has passed or whose ingredient content does not conform to national drug standards.

Explanation: Under Article 98 of the PRC Drug Administration Law, a drug is classified as a Substandard/Inferior Drug (劣药) if its active ingredient content does not conform to national standards, if it is expired (超过有效期的), if its expiration date is not indicated or is altered, if packaging materials/containers do not meet standards, or if unauthorized excipients/colorants are added. In contrast, drugs with non-conforming ingredients (成分不符), fake substances claimed to be drugs, unapproved/banned APIs, or products fabricated by unapproved entities are classified as Counterfeit Drugs (假药).

5Which set of core principles governs the selection, inclusion, and dynamic catalog adjustment of the National Essential Medicines List (国家基本药物目录) in China?

A.Highest market retail price, novel imported patent formulations, and specialist hospital exclusivity.

B.Clinical necessity, safety and efficacy, reasonable price, convenient administration, and dynamic adjustment.

C.Unrestricted patient self-selection, exemption from GSP distribution requirements, and maximum profit margin for distributors.

D.Strict restriction to hospital-prepared compounding formulas (医疗机构制剂) without commercial market presence.

Explanation: China's National Essential Medicines System (国家基本药物制度) adheres to the guiding principles: 'Clinical necessity, safety and efficacy, reasonable price, convenient administration, equal emphasis on Traditional Chinese Medicine and Western Medicine, guaranteed market supply, and dynamic adjustment' (防治必需、安全有效、价格合理、使用方便、中西药并重、保障生产供应、动态调整).

6Under the Drug Marketing Authorization Holder (MAH / 药品上市许可持有人) system established in the PRC Drug Administration Law, what is the core legal responsibility of the MAH?

A.The MAH bears comprehensive statutory legal responsibility for drug safety, efficacy, and quality management throughout the full lifecycle of the drug.

B.The MAH is only responsible for laboratory preclinical development and transfers all post-marketing safety liability to contracted contract manufacturing organizations (CMOs).

C.The MAH is legally immune from civil damages if adverse reactions occur during Phase IV clinical surveillance.

D.The MAH's liability is strictly limited to advertising review while the retail pharmacy assumes all drug recall responsibilities.

Explanation: Under China's MAH system (药品上市许可持有人制度), the enterprise or research institution holding the drug registration certificate is the Marketing Authorization Holder. The MAH is legally responsible for the entire lifecycle of the drug (全生命周期管理), including non-clinical research, clinical trials, commercial manufacturing (whether self-produced or contracted to CMOs), wholesale distribution, post-marketing safety monitoring, adverse drug reaction (ADR) reporting, and mandatory recall execution.

7According to China's Good Manufacturing Practice for Pharmaceutical Products (GMP / 药品生产质量管理规范), which cleanroom classification tier represents the high-risk operational zone (e.g., aseptic filling, rubber stopper bowls, open ampoules) requiring laminar unidirectional airflow (0.36–0.54 m/s)?

A.Grade D Clean Area (D级洁净区)

B.Grade C Clean Area (C级洁净区)

C.Grade A Clean Area (A级洁净区)

D.Grade B Clean Area (B级洁净区)

Explanation: Under Chinese GMP Annex 1 (Sterile Medicinal Products / 无菌药品), clean areas are categorized into four grades: Grade A (A级) is the high-risk operational zone (such as filling area, stopper bowls, open ampoules/vials) requiring unidirectional laminar airflow with a velocity of 0.36–0.54 m/s; Grade B (B级) is the background environment for Grade A aseptic preparation; Grade C and Grade D (C级和D级) are clean areas for less critical steps in the manufacture of sterile products.

8According to the Prescription Administrative Measures (处方管理办法), what is the maximum statutory prescription quantity for Narcotic Drugs and Class I Psychotropic Drugs in oral non-injectable formulations for an outpatient suffering from severe cancer pain (晚期癌症疼痛)?

A.A maximum of 1 single dose (1次常用量)

B.A maximum of 3 days' regular dosage (3日常用量)

C.A maximum of 7 days' regular dosage (7日常用量)

D.A maximum of 15 days' regular dosage (15日常用量)

Explanation: Under the Prescription Administrative Measures (处方管理办法), for outpatients: (1) General Narcotic/Class I Psychotropic injections are limited to 1 single dose (1次常用量); (2) General non-injection formulations are limited to a 3-day supply (3日常用量); (3) For patients with severe cancer pain or severe chronic intractable pain, non-injection formulations (such as sustained-release oral morphine or fentanyl transdermal patches) may be prescribed up to a maximum of 15 days' regular dosage (不超过15日常用量); (4) Class II Psychotropic drugs generally do not exceed a 7-day supply (7日常用量).

9Under the Provisions on the Administration of Pharmaceutical Package Inserts and Labels (药品说明书和标签管理规定), which requirement must be strictly satisfied regarding the generic name (通用名称) of a drug on its packaging label?

A.The trade name must be printed in font size at least three times larger than the generic name.

B.The generic name must be prominent, clearly readable, and its font area must not be less than one-half (1/2) the font area of the registered trade name.

C.The generic name may be omitted entirely if the brand has a well-known registered trademark in China.

D.The generic name must only appear on the inner package insert and is prohibited on outer packaging boxes.

Explanation: Under statutory Chinese labeling regulations, the established generic name (通用名称) must be prominently displayed in a clear and conspicuous manner on both inner and outer labels. When a registered trade name (商品名称) is included, the generic name's font size, boldness, and background contrast must make it prominent, and the single-character font area of the generic name must be at least one-half (≥ 1/2) the size of the trade name.

10Under the Administrative Measures on Reporting and Monitoring of Adverse Drug Reactions (药品不良反应报告和监测管理办法), what is the statutory deadline for MAHs and medical institutions to report an individual 'Serious Adverse Drug Reaction' (严重不良反应)?

A.Within 15 calendar days from the date of discovery/awareness.

B.Within 30 calendar days at the end of the operating quarter.

C.Within 6 months during the annual pharmacovigilance submission.

D.Within 72 hours only if the patient undergoes legal litigation.

Explanation: Under Chinese pharmacovigilance regulations, individual 'Serious Adverse Drug Reactions' (严重药品不良反应) must be reported to the National ADR Monitoring System within 15 calendar days (15日内) of awareness. In cases involving death (死亡病例), the report must be submitted immediately, but no later than 7 calendar days (7日内). General/non-serious ADRs must be reported within 30 calendar days (30日内).

About the Licensed Pharmacist Qualification (China) Exam

The China Licensed Pharmacist Professional Qualification Examination (全国执业药师职业资格考试) is the benchmark statutory credential for practicing pharmacists in the People's Republic of China. Jointly organized by the National Medical Products Administration (NMPA / 国家药品监督管理局) and the Ministry of Human Resources and Social Security (MOHRSS / 人力资源和社会保障部), the qualification verifies professional competency in pharmacy law compliance, drug distribution quality management (GSP/GMP), biopharmaceutics, clinical pharmacology, prescription auditing, therapeutic drug monitoring, and patient counseling.

Assessment

Paper 1: 药事管理与法规 (Pharmacy Affairs & Regulations); Paper 2: 药学专业知识（一） (Medicinal Chemistry & Pharmaceutics); Paper 3: 药学专业知识（二） (Pharmacology & Clinical Therapeutics); Paper 4: 药学综合知识与技能 (Comprehensive Clinical Pharmacy Practice). Standardized objective MCQs administered across a 4-year rolling qualification cycle.

Time Limit

90 minutes per subject paper (360 minutes total across four papers)

Passing Score

60 out of 100 points per subject within the applicable four-year rolling cycle

Exam Fee

Set provincially; consult the current local registration notice (National Medical Products Administration (NMPA) & Ministry of Human Resources and Social Security (MOHRSS))

Licensed Pharmacist Qualification (China) Exam Content Outline

25%

Pharmacy Affairs, Drug Administration Laws & GMP/GSP Regulations (药事管理与法规)

Evaluates knowledge of PRC pharmaceutical laws, regulations, and quality standards: PRC Drug Administration Law, Marketing Authorization Holder (MAH) system obligations, legal definitions and penalties for counterfeit (假药) and substandard (劣药) drugs, National Essential Medicines policies, Good Supply Practice (GSP) warehouse temperature zones (normal, cool ≤20°C, cold storage 2–8°C) and RH controls (35%–75%), Good Manufacturing Practice (GMP) clean area classifications (Grade A, B, C, D), Good Clinical Practice (GCP) phase trials, special controlled substances (narcotics, Class I/II psychotropics, toxic drugs, radiopharmaceuticals) dual-person lock and prescription limits, prescription color coding and retention durations (1, 2, 3 years), Adverse Drug Reaction (ADR) reporting requirements (15-day serious ADR timeline), and online pharmaceutical sales supervision.

25%

Medicinal Chemistry & Pharmaceutics: Formulations, Quality & Pharmacokinetics (药学专业知识一)

Covers pharmaceutical formulation science, physical pharmacy, drug delivery systems, and biopharmaceutics: solid oral dosage forms and functional excipients (diluents, binders, disintegrants, lubricants), sterile injectable preparations, pyrogen and bacterial endotoxin testing (TAL/LAL Limulus test, dry heat 250°C), modified-release formulations (osmotic pumps, matrix tablets, microcapsules), surfactant properties (HLB values, Spans vs Tweens), chemical degradation pathways (hydrolysis, oxidation) and stabilization, biopharmaceutics classification system (BCS Class I–IV), pharmacokinetic parameters (AUC, clearance $CL$, volume of distribution $V_d$, elimination half-life $t_{1/2}$, steady-state concentration $C_{ss}$), bioequivalence (BE 80.00%–125.00% CI), and structure-activity relationships (SAR) of major drug classes.

30%

Pharmacology & Clinical Therapeutics: Drug Mechanisms, Indications & ADRs (药学专业知识二)

Comprehensive evaluation of clinical pharmacology, pharmacodynamics, and therapeutics: cardiovascular agents (antihypertensives, heart failure guideline-directed medical therapy four pillars, statins, antiarrhythmics Vaughan-Williams classification), endocrine and metabolic therapies (oral hypoglycemics, GLP-1 RAs, SGLT2 inhibitors, thyroid hormones and antithyroid agents, osteoporosis bisphosphonates), anti-infective therapy (beta-lactams, aminoglycosides, fluoroquinolones, macrolides, glycopeptides, antituberculosis HRZE regimen, systemic antifungals, antivirals), nervous system medications (sedative-hypnotics, antiepileptics, antiparkinsonian drugs, antidepressants, antipsychotics, opioid analgesics and reversal), antineoplastic targeted therapies, and clinical adverse drug reactions.

20%

Comprehensive Pharmacy Practice, Prescription Review & Patient Counseling (药学综合知识与技能)

Focuses on applied clinical pharmacy, patient safety, and pharmaceutical care: statutory four-step prescription review system (四查十对), identification and resolution of drug-drug interactions (DDIs) and physical/chemical incompatibilities (e.g. ceftriaxone with calcium solutions), therapeutic drug monitoring (TDM target ranges for digoxin, theophylline, vancomycin, lithium), special population dosing adjustments (pediatric BSA/weight formulas, contraindications, pregnancy/lactation risk assessment, renal impairment Cockcroft-Gault CrCl calculations, hepatic Child-Pugh grading), specific poisoning antidotes, high-alert medication safeguards, total parenteral nutrition (TPN) compounding rules, and patient counseling on specialized dosage forms (MDIs, DPIs, transdermal patches).

How to Pass the Licensed Pharmacist Qualification (China) Exam

What You Need to Know

Passing score: 60 out of 100 points per subject within the applicable four-year rolling cycle
Assessment: Paper 1: 药事管理与法规 (Pharmacy Affairs & Regulations); Paper 2: 药学专业知识（一） (Medicinal Chemistry & Pharmaceutics); Paper 3: 药学专业知识（二） (Pharmacology & Clinical Therapeutics); Paper 4: 药学综合知识与技能 (Comprehensive Clinical Pharmacy Practice). Standardized objective MCQs administered across a 4-year rolling qualification cycle.
Time limit: 90 minutes per subject paper (360 minutes total across four papers)
Exam fee: Set provincially; consult the current local registration notice

Keys to Passing

Work through all 100 available questions
Review every answer and explanation
Track weak areas and revisit them
Use our AI tutor for tough concepts

Licensed Pharmacist Qualification (China) Study Tips from Top Performers

1Master GSP and Storage Temperature Rules: Memorize exact statutory storage zones under Good Supply Practice: Normal temperature (常温 10–30°C), Cool (阴凉 ≤20°C), Cold storage (冷藏 2–8°C), and Relative Humidity (35%–75%).

2Understand Special Controlled Substances Governance: Ensure complete clarity on storage (dedicated double-locked safe 双人双锁), prescription paper color (Light red for narcotics and Class I psychotropics), and outpatient dispensing quantity limits (1-dose injection, 3-day non-injection, 7-day Class II psychotropics, 15-day chronic cancer pain).

3Internalize Pharmacokinetic and Bioequivalence Parameters: Be ready to calculate clearance, volume of distribution, elimination half-life, and steady-state concentration, and memorize the 90% confidence interval bioequivalence standard of 80.00%–125.00%.

4Memorize First-Line Therapeutics and Contraindications: Master key clinical guidelines including the Heart Failure 'Four Pillars' (ARNI/ACEI/ARB, Beta-blocker, MRA, SGLT2i), statin myopathy/CK monitoring, and absolute contraindications of ACEIs/ARBs in bilateral renal artery stenosis and pregnancy.

5Internalize Four-Step Prescription Review (四查十对): Master the statutory verification workflow: Check Prescription (查处方: 科别、姓名、年龄), Check Drug (查药品: 药名、剂型、规格、数量), Check Pairing (查配伍禁忌: 药品性状、用法用量), and Check Rationality (查用药合理性: 临床诊断).

6Review Specific Poisoning Antidotes and Toxicities: Memorize key antidote pairs (Paracetamol – N-acetylcysteine, Organophosphates – Pralidoxime/Atropine, Benzodiazepines – Flumazenil, Opioids – Naloxone, Anthracyclines – Dexrazoxane).

Frequently Asked Questions

What is the China Licensed Pharmacist Qualification Examination and what authority does it confer?

The Licensed Pharmacist Qualification Examination (全国执业药师职业资格考试) is China's official national statutory licensing examination for pharmacists. Jointly organized by the National Medical Products Administration (NMPA / 国家药品监督管理局) and the Ministry of Human Resources and Social Security (MOHRSS / 人力资源和社会保障部), passing the examination confers the statutory Licensed Pharmacist (执业药师) qualification certificate, which is legally required to supervise drug dispensing, manage retail pharmacies, and perform pharmaceutical quality assurance across the People's Republic of China.

What is the examination structure, duration, and rolling qualification cycle?

The examination comprises four computer-based objective subject papers: 药事管理与法规 (Pharmacy Affairs and Regulations), 药学专业知识（一） (Pharmacy Professional Knowledge I), 药学专业知识（二） (Pharmacy Professional Knowledge II), and 药学综合知识与技能 (Comprehensive Pharmacy Knowledge and Skills). Under the national qualification system, candidates taking all four subjects have a 4-year cumulative rolling cycle (连续4个考试年度) to pass all four papers with a score of at least 60% (72/120 points under the 120-point system, or 60/100 points under the 100-point format).

What educational prerequisites and work experience are required to register?

Under official NMPA/MOHRSS regulations, candidates must hold a recognized degree in Pharmacy (药学), Traditional Chinese Medicine (中药学), or related fields: (1) Associate degree (大专) with at least 4 years of pharmaceutical work experience; (2) Bachelor's degree (本科) with at least 2 years of experience; (3) Master's degree or Second Bachelor's with at least 1 year of experience; or (4) Ph.D. degree with no prior experience required. Candidates with degrees in related pharmaceutical disciplines require 1 additional year of professional experience.

When is the examination held and how is registration conducted?

The national examination is held annually in October. Registration opens nationally in August through the official China Personnel Examination Center portal (中国人事考试网, http://www.cpta.com.cn). Registration fees typically range between ¥200 and ¥280 RMB total (approximately ¥50 to ¥70 RMB per subject paper), determined by provincial finance and examination authorities.

Why is this OpenExamPrep practice bank presented in English?

The official examination in China is conducted entirely in Simplified Chinese. This OpenExamPrep module provides 100 high-yield multiple-choice questions in English designed to build conceptual mastery for bilingual healthcare professionals, international clinical pharmacists, multinational pharmaceutical compliance specialists, and expatriates navigating Chinese pharmaceutical regulations and clinical guidelines. Authentic dual-language Chinese terminology (such as 处方药与非处方药, GSP药品经营质量管理规范, 处方审核四查十对, 药物相互作用, 不良反应监测 ADR) is systematically embedded throughout to ensure seamless cross-referencing.