Error-prone Test Set of Pharmaceutical Affairs Management and Licensed Pharmacist Examination Rules (2)
Chapter IV Drug Development and Production Management
1, the main body of the investigation and evaluation of drugs that may have potential safety hazards is ()
A. Pharmaceutical manufacturing enterprises
B. Pharmaceutical trading enterprises
C. Medical institutions
D. Drug inspection agencies
Reference answer: a
Test difficulty: this question was answered 228 times, the correct rate was 76%, and the error-prone items were A and D?
Reference analysis: drug manufacturers are the main body responsible for drug recall; Complete purchase and sale records shall be kept, a drug recall system shall be established and improved, information related to drug safety shall be collected, drugs with potential safety hazards shall be investigated and evaluated, and drugs with potential safety hazards shall be recalled. Therefore, choose A. It is recommended that candidates use the formula "Production Memory Evaluation Subject" to accurately remember.
2, the key personnel of pharmaceutical production enterprises include ()
A. Person in charge of enterprise
B. Legal representative
C. person in charge of production management
D. quality authorized personnel
Reference answer: a, c, d
Test difficulty: this question was answered 203 times, the correct rate was 52%, and the error-prone items were A and C.
Reference analysis: The key personnel of a pharmaceutical production enterprise should be full-time personnel of the enterprise, including at least the person in charge of the enterprise, the person in charge of production management and the quality authorizer. So choose a, c and d.
3, about drug production, the mistake is ()
The improvement of pharmaceutical production technology must be reported to the state pharmaceutical supervisory and administrative department for the record.
The improvement of pharmaceutical production technology must be reported to the provincial drug supervision and administration department for approval.
The processing of Chinese herbal pieces must follow the processing standards formulated by the provincial drug supervision and administration department.
D. Before Chinese herbal pieces leave the factory, the production enterprise must conduct quality inspection on them.
Reference answers: a, b, c
Test difficulty: this question was answered 206 times, the correct rate was 22%, and the error-prone items were C and A.
Reference analysis: (1) drug production: drugs must be produced in accordance with the national drug standards and the production process approved by the state drug supervision and administration department. Production records must be complete and accurate. Drug production enterprises must report to the original calibration department for examination and approval if they change the production process that affects the quality of drugs. Therefore, A and B are wrong. ?
(2) Self-inspection of drugs before leaving the factory: ① Drug manufacturers must conduct quality inspection on the drugs they produce; (two) does not meet the national drug standards or not in accordance with the provincial drug supervision and management departments to develop Chinese herbal pieces processing standards, shall not leave the factory. So d is right and c is wrong.
4, about the supervision and management of drug production, the correct ()
Pharmaceutical manufacturing enterprises that add new dosage forms shall apply for good manufacturing practice certification in accordance with the regulations.
B a pharmaceutical manufacturer certified by good manufacturing practice can be entrusted to produce traditional Chinese medicine injections.
C. If a pharmaceutical production enterprise changes the licensed items of the Pharmaceutical Production License, it shall apply for registration of change 30 days before the change of the licensed items.
D. If a pharmaceutical production enterprise stops production or business, its Pharmaceutical Production License shall be revoked by the original issuing department.
Reference answer: a, c, d
Test difficulty: this question was answered 203 times, the correct rate was 7 1%, and the error-prone items were d and C.
Reference analysis: (1) Narcotic drugs, psychotropic drugs, pharmaceutical precursor chemicals and their compound preparations, toxic drugs for medical use, biological products, multi-component biochemical drugs, traditional Chinese medicine injections and APIs may not be commissioned for production, so B is wrong. ?
(2) If a pharmaceutical production enterprise changes the licensed items of the Pharmaceutical Production License, it shall apply for registration of change 30 days before the change of the licensed items, so C is correct. ?
(3) If a pharmaceutical production enterprise stops producing drugs or goes bankrupt, its pharmaceutical production license shall be revoked by the original issuing department, so D is correct. ?
(4) Newly established pharmaceutical manufacturing enterprises or new workshops should apply for GMP certification according to regulations, so A is correct.
5, for drugs with potential safety hazards, the following statement is correct ()
A. After the pharmaceutical production enterprise decides to recall, it shall notify the pharmaceutical trading enterprise and users to stop selling and using the drug within the specified time.
Pharmaceutical trading enterprises shall assist pharmaceutical production enterprises in fulfilling the obligation of drug recall.
C the user should report to the health administrative department and wait for the notice of stopping medication.
When the pharmaceutical supervisory and administrative department investigates the hidden dangers of drug safety, the pharmaceutical production enterprises shall withdraw.
Reference answers: a, b
Test difficulty: This question was answered 172 times, the correct rate was 55%, and the error-prone items were A and B.
Reference analysis: (1) After making a drug recall decision, a pharmaceutical manufacturer shall make a recall plan and organize its implementation. The first-level recall shall be within 24 hours, the second-level recall shall be within 48 hours, and the third-level recall shall be within 72 hours. Notify relevant pharmaceutical trading enterprises and users to stop selling and using drugs, and report to the local provincial pharmaceutical supervisory and administrative department at the same time. Therefore, A is correct. ?
(2) When the pharmaceutical supervisory and administrative department investigates the hidden dangers of drug safety, the pharmaceutical production enterprises shall provide assistance. So, d is wrong. ?
(3) Pharmaceutical trading enterprises and users shall assist pharmaceutical production enterprises in fulfilling their recall obligations, timely convey and feed back information on drug recall according to the requirements of the recall plan, and control and recall drugs with potential safety hazards. When a pharmaceutical trading enterprise or user discovers that the drugs it deals in or uses have potential safety hazards, it shall immediately stop selling or using them, notify the pharmaceutical production enterprise or supplier, and report to the pharmaceutical supervisory and administrative department. So, B is right and C is wrong.
6, the main body of the investigation and evaluation of drugs that may have potential safety hazards is ()
A. Pharmaceutical manufacturing enterprises
B. Pharmaceutical trading enterprises
C. Medical institutions
D. Drug inspection agencies
Reference answer: a
Test difficulty: this question was answered 228 times, the correct rate was 76%, and the error-prone items were A and D?
Reference analysis: drug manufacturers are the main body responsible for drug recall; Complete purchase and sale records shall be kept, a drug recall system shall be established and improved, information related to drug safety shall be collected, drugs with potential safety hazards shall be investigated and evaluated, and drugs with potential safety hazards shall be recalled. Therefore, choose A. It is recommended that candidates use the formula "Production Memory Evaluation Subject" to accurately remember.
7. According to the Opinions of the State Council on Reforming the Examination and Approval System of Medicines and Medical Devices (Guo Fa [2015] No.44), the main tasks of the examination and approval system reform of medicines and medical devices in China include ().
A improve the examination and approval of drug clinical trials, allow overseas unlisted new drugs to carry out clinical trials in China after approval, and encourage domestic clinical trial institutions to participate in international multi-center clinical trials.
B. Implement a special review and approval system for innovative drugs, and accelerate the review and approval of new drugs urgently needed in clinic.
C for generic drugs that have been approved for marketing, the quality consistency evaluation shall be conducted in stages and batches according to the principle of consistency with the quality and efficacy of the original drug.
D. Pilot the drug marketing license holder system, allowing drug research and development institutions and drug trading enterprises to apply for new drug registration.
Reference answers: a, b, c
Test difficulty: this question is answered 190 times, the correct rate is 4 1%, and the error-prone items are C and B.
Reference analysis: the State Council's Opinions on Reforming the Examination and Approval System of Medicines and Medical Devices puts forward: (1) Improve the examination and approval of drug clinical trials: allow overseas unlisted new drugs to carry out clinical trials simultaneously in China after approval, and encourage domestic clinical trial institutions to participate in international multi-center clinical trials. The test data that meet the requirements can be used for registration applications. Therefore, A is correct.
(2) Implement a special review and approval system for innovative drugs: speed up the review and approval of new drugs urgently needed in clinic, and enterprises applying for new drug registration should promise that the price of their products listed and sold in China is not higher than the comparable market price in the country of origin or around China. Therefore, B is correct.
(3) Improving the quality of generic drugs: The original drug should be used as a reference preparation in the review and approval of generic drugs to ensure that the quality and efficacy of the newly approved generic drugs are consistent with those of the original drug. The application for drug registration accepted before the reform will continue to be reviewed and approved in accordance with the original provisions, and the consistency with the quality and efficacy of the original drugs will be gradually solved in the quality consistency evaluation. So, C is correct.
(4) Pilot drug marketing license holder system: drug research and development institutions and scientific researchers are allowed to apply for new drug registration, and only on-site process verification and product inspection of the production enterprise are carried out when they are transferred to enterprise production, and drug technical evaluation is not repeated. So, d is wrong.
8, about the listing permit system, the correct is ()
Drug research and development institutions or researchers in the pilot administrative area may be used as applicants for drug registration.
B drug research and development institutions or scientific researchers in the pilot administrative area may become drug marketing license holders if they have obtained the drug marketing license and drug approval number.
The holder of the drug marketing license must entrust a qualified drug production enterprise in the pilot administrative area to produce the drug approved for marketing.
D. When the drug marketing license holder transfers it to an enterprise for production, it is necessary to conduct drug technical review, on-site process verification of the production enterprise and product inspection.
Reference answers: a, b
Test difficulty: This question was answered 209 times, the correct rate was 24%, and the error-prone items were B and A..
Reference analysis: (1) Pharmaceutical R&D institutions or scientific researchers in the pilot administrative area can apply for drug clinical trials and drug marketing as applicants for drug registration. An applicant who has obtained a drug marketing license and a drug approval number may become the holder of a drug marketing license. Therefore, A and B are correct. ?
(2) If the holder does not have the corresponding production qualification, he shall entrust a qualified pharmaceutical production enterprise in the pilot administrative area to produce the drug approved for listing; If the holder has the corresponding production qualification, he can produce it by himself or entrust a production enterprise to produce it. So, c is wrong. ?
(3) When the holder is transferred to the enterprise for production, only the on-site process verification and product inspection of the production enterprise will be carried out, and the drug technical review will not be repeated. So, d is wrong.
9, according to the new drug registration special examination and approval management regulations, can speed up the new drug review and approval including ()
A. Effective components extracted from plants, animals, minerals and other substances that have not been marketed in China and their preparations.
B. Newly discovered medicinal materials and their preparations
C. Biological products not approved for marketing at home and abroad
D. new drugs for diseases that cannot be effectively treated.
Reference answers: a, b, c, d
Test difficulty: this question was answered 198 times, the correct rate was 33%, and the error-prone items were B and A.
Reference analysis: New drugs subject to special approval and accelerated review and approval include:
(1) Active ingredients and their preparations extracted from plants, animals, minerals and other substances that have not been marketed in China, and newly discovered medicinal materials and their preparations. Therefore, A and B are correct. ?
(2) Chemical APIs and their preparations and biological products that have not been approved for marketing at home and abroad. So, C is correct. ?
(3) new drugs with obvious clinical treatment advantages for AIDS, malignant tumors, rare diseases and other diseases. ?
(four) new drugs for diseases without effective treatment. Therefore, d is correct.
10 According to the Announcement on Several Policies for Drug Registration Review and Approval, drugs that can be queued separately to speed up the review and approval include ()
A. Application for registration of innovative drugs to prevent and treat AIDS, malignant tumors, major infectious diseases and rare diseases
B an application for clinical trial of drugs that is urgently needed in clinic and 2 years before the patent expires.
C. Apply for pharmaceutical production two years before the patent expires
D. Children's drug registration application
Reference answers: a, d
Test difficulty: this question was answered 196 times, the correct rate was 42%, and the error-prone items were A and D.
Reference analysis: Drugs queued separately to speed up the review and approval include:
(1) Application for registration of innovative drugs to prevent and treat AIDS, malignant tumors, major infectious diseases and rare diseases. Therefore, A is correct.
(2) Children's medication registration application. Therefore, d is correct.
(3) Application for drug registration of diseases peculiar to the elderly and multiple diseases.
(4) Application for drug registration included in national key scientific and technological projects and national key R&D plans.
(5) Application for registration of drugs urgently needed in clinic with advanced technology, innovative treatment methods and obvious treatment advantages.
(6) Application for registration of innovative drugs produced in China.
(seven) the applicant applies for clinical trials of new drugs in the EU and the United States at the same time and is allowed to carry out clinical trials of drugs, or the application for drug registration that is produced in China with the same production line and applied for listing in the EU and the United States at the same time and passed the on-site inspection by its drug examination and approval authorities.
(8) An application for clinical trial of drugs urgently needed in clinic and 3 years before the patent expires and an application for drug production before the patent expires 1 year. Therefore, b and c are wrong.