Official Announcement: List of Revisions to Volume One of the 2020 Pharmacopoeia

Published in: Chinese Pharmaceutical Standards, Vol. 21, No. 4

Yue Zhihua, Wang Zhijun, Cheng Qilei, Wang Fei, Zhou Yi, Zhang Xiaohong, Yue Ruiqi, Li Huiyi*

Abstract: The 2020 Edition of the Chinese Pharmacopoeia is about to be promulgated and implemented. This article provides a detailed overview of the development process, format optimization, selection of entries, standardization of generic names, revision of the General Notes, and additions and revisions to the monograph standards in Volume Two of the 2020 Edition, with relevant examples for each aspect, so as to facilitate readers’ better understanding and implementation of the new edition of the Pharmacopoeia.

Keywords: Pharmacopoeia of the People’s Republic of China, 2020 Edition, Volume II; Amendments and Revisions; Enhancement of Pharmaceutical Standards

Chinese Library Classification number: R 921.2 Document Identification Code :A Article Number: 1009-3656(2020)-4-0285-5

doi ：10.19778/j.chp.2020.04.001

Updates and Amendments to the Chinese Pharmacopoeia 2020

(Volume II )

YUE Zhihua, WANG Zhijun, CHENG Qilei, WANG Fei, ZHOU Yi, ZHANG Xiaohong, YUE Ruiqi, LI Huiyi

(Chinese Pharmacopoeia Commission, Beijing 100061, China)

Abstract ： The Pharmacopeia of the People’s Republic of China 2020 (the Chinese Pharmacopoeia 2020, ChP 2020) will be promulgated and implemented shortly. This article outlines the procedures for establishing drug quality standards, the optimization of standard formats, the selection of drugs, the use of generic names, and the major revisions to the monographs and general notices in Volume II of the ChP 2020, and provides illustrative analyses and explanations to assist readers in understanding and implementing the ChP 2020.

Key words ： The Chinese Pharmacopoeia 2020 (Volume II) (ChP 2020, Volume II); Updates and amendments to drug quality standards; Improvement of drug quality standards

The compilation of the 2020 edition of the Pharmacopoeia of the People’s Republic of China (hereinafter referred to as the “Chinese Pharmacopoeia”) [1] has once again spanned a five-year period and will be promulgated by the National Medical Products Administration, entering into force on December 30, 2020. The new edition comprises four volumes, with Volume Two primarily covering chemical drugs. Over the past five years, guided by the principle of establishing “the most rigorous standards,” the National Pharmacopoeia Committee has meticulously coordinated the relevant authorities and the specialized committees for chemical drugs, working in unison to successfully complete the compilation of Volume Two of the 2020 Chinese Pharmacopoeia. What are the principles governing the inclusion of entries in this volume? What are the main changes in the General Notes and the body of the monographs? And what are the principal technical principles underlying the development and revision of national standards? To enable users of the Chinese Pharmacopoeia to better understand and implement this volume, this article provides a concise overview of its key features and the major additions and revisions.

The 2020 Edition, Volume II of the Chinese Pharmacopoeia adheres to the selection principles of “commonly used in clinical practice, with proven efficacy, safe for use, with mature manufacturing processes, and with controllable quality.” Only those products that have undergone the national pharmaceutical standards enhancement initiative, whose standard monographs are relatively comprehensive, and that have been selected and approved by the Medical Expert Committee and the Pharmaceutical Expert Committee are eligible for inclusion in the new edition of the Pharmacopoeia. For example, the antidiabetic drug voglibose is available in multiple dosage forms, including tablets, capsules, dispersible tablets, and chewable tablets; however, only the tablet and capsule formulations were included, while the dispersible and chewable forms were excluded due to doubts about their appropriateness as dosage forms. The hepatoprotective agent glutathione tablets were included, but glutathione lozenges were not, owing to concerns regarding the rationality of that dosage form. Similarly, the gastrointestinal medication vitamin U–belladonna–aluminum–magnesium capsules and the calcium-supplement chewable calcium lactate tablets were both excluded because their clinical utility remains questionable. The new edition of the Pharmacopoeia further expands its coverage to encompass both the National Essential Medicines List and the National Basic Medical Insurance Drug List. For instance, newly added entries such as mesna injection and capecitabine tablets are all listed in the latest edition of the Essential Medicines List (2018) [2] and the Medical Insurance Drug List (2019) [3].

Eight entries listed in Volume II of the 2015 Edition of the Chinese Pharmacopoeia [4] have not been retained in the new edition. These entries can be categorized as follows: (1) Recombinant human insulin, recombinant human insulin injection, protamine recombinant human insulin injection, recombinant human growth hormone, and injectable recombinant human growth hormone—five items that were removed from Volume II because they are biological products; (2) Products whose drug registration numbers were revoked by an official document issued by the National Medical Products Administration, such as pyritinol hydrochloride injection and injectable pyritinol hydrochloride; and (3) Products with serious deficiencies in their quality standards, such as cod liver oil. Although this product should primarily be derived from extracts of marine fish organs, the current standard fails to adequately reflect its critical quality attributes. Work is currently underway to upgrade the standard for this product; therefore, it has not been retained in the new edition of the Pharmacopoeia.

Following a rigorous selection process, Volume II of the 2020 Edition of the Chinese Pharmacopoeia includes a total of 2,712 entries, comprising 117 newly added entries, 196 entries that have undergone major revisions, and 2,595 entries retained from Volume II of the 2015 Edition of the Chinese Pharmacopoeia [2].

The generic name of a drug serves as the foundation for its production, use, and regulatory oversight, and is an essential component of drug standards. The Name and Terminology Specialist Committee of the National Pharmacopoeia Commission is responsible for the nomenclature of generic drug names as well as the Chinese translations of the World Health Organization’s (WHO) International Nonproprietary Names (INNs).

To better align with international standards, the common names of active pharmaceutical ingredients for chemical drugs are generally designated in accordance with the Chinese names of the INN. The new edition of the Pharmacopoeia has revised vitamin B4 to adenosine phosphate and fluorouridine to fluorouracil, among others; in line with the nomenclature principles, cefazolin sodium pentahydrate has been incorporated into cefazolin sodium, with corresponding revisions made to the molecular structural formula, molecular weight, and chemical name of cefazolin sodium to cover both the anhydrous and pentahydrate forms.

The basic nomenclature for pharmaceutical preparations is [active pharmaceutical ingredient name][route of administration][dosage form]. Based on this principle, the new edition of the Pharmacopoeia has revised the generic names of certain drugs as follows: (1) Clotrimazole suppositories containing expanding cotton plugs have been renamed Clotrimazole Vaginal Expanding Suppositories to distinguish them from ordinary suppositories, thereby preventing patient misuse and enhancing the safety of clinical medication; (2) Following a survey, it was found that sodium citrate products indicated solely for in vitro anticoagulation of single-donor plasma exhibit three different names—“Sodium Citrate Solution for Anticoagulation,” “Sodium Citrate Injection for Blood Transfusion,” and “Sodium Citrate Anticoagulant.” In accordance with the naming principles, the product name for this indication has been standardized as “Sodium Citrate Solution for Anticoagulation”; (3) Since Adenosine Injection (for Diagnostic Use) and Adenosine Injection have identical compositions and concentrations, the drug name has been unified as Adenosine Injection. The specification for Adenosine Injection (for Diagnostic Use) has been added under the Adenosine Injection specification section and clearly labeled for differentiation, while the package inserts for the two specifications remain distinct.

The General Notes constitute the fundamental principles for the proper application of the Chinese Pharmacopoeia in pharmaceutical quality testing; they provide unified provisions covering the main text, general rules, and common issues related to quality testing, and serve as the rules that must be jointly observed throughout the processes of drug production, distribution, and use. Therefore, it is of paramount importance to correctly understand and apply the General Notes. The General Notes of Volume II of the 2020 Edition of the Chinese Pharmacopoeia have undergone revisions primarily in the following areas.

(1) Article 15 of the General Notes: Add the following statement to the section on physical characteristics: “Here, ‘odor and taste’ refer to those inherent to the drug substance itself and may be used as a reference during formulation development.” This addition clarifies the description of odor and taste in the characteristics of active pharmaceutical ingredients, such that routine quality control testing is not required for these attributes. (2) Article 21 of the General Notes: Revise the definition of “light protection” from “referring to packaging in opaque containers, such as brown containers or colorless, transparent or translucent containers wrapped in black paper” to “referring to packaging in opaque containers, such as brown containers or colorless, transparent or translucent containers appropriately wrapped in black materials,” thereby making the description more precise. (3) Articles 9 and 22 of the General Notes: Add an “annotation” item to the main text of each monograph, defining it as “information required for conducting testing and other related activities, which shall be indicated by appropriate means (such as the drug package insert).” For example, in the revised edition of the Pharmacopoeia, the monograph for bendazol lysine ophthalmic solution now includes the following annotation at the end of the standard: “The amount of preservative shall be indicated on the product label or in the instructions for use,” in order to strengthen the control of preservatives in ophthalmic preparations and ensure drug safety. (4) Article 24 of the General Notes: For monographs where testing methods other than those specified in the Pharmacopoeia are employed, add a requirement that methodological validation must be performed, thereby further ensuring the accuracy and suitability of the testing methods.

The quality standards for pharmaceutical safety primarily cover manufacturing process requirements, related substances, color and clarity, residual solvents, heavy metals, visible foreign matter, osmotic pressure, bacterial endotoxins, microbial limits, and sterility. The 2020 Edition of the Chinese Pharmacopoeia, Volume II, has specifically added to or revised these items in light of the production processes and dosage-form characteristics of each individual drug product.

4.1 Add related substances testing items, optimize the testing methods, and implement stringent limit controls.

Related substances play a crucial role in ensuring the safety of pharmaceutical products, and this testing item is one of the core components of pharmaceutical standards. The methods and limits for related substances included in the latest edition of the Pharmacopoeia are more scientific and rational. For example: (1) The original standard for fluorouridine was the national drug regulatory authority–issued standard WS1-XG-026-2001, while the original standard for diphenoxylate hydrochloride was Volume II of the 2015 Edition of the Chinese Pharmacopoeia; neither of these original standards included a related-substances test, but the new Pharmacopoeia has now added such a test for both compounds. (2) For flutamide, the 2015 Edition of the Pharmacopoeia specified thin-layer chromatography (TLC) as the method for related substances, with control only over impurity I at a limit of no more than 1.0%; the new Pharmacopoeia has revised this method to high-performance liquid chromatography (HPLC), thereby enhancing the method’s specificity, accuracy, and sensitivity, and has also tightened the limits for impurities, stipulating that impurity I shall not exceed 0.2%, any single unknown impurity shall not exceed 0.2%, and the sum of all other unknown impurities shall not exceed 0.3%. Other examples of related-substances tests that have been optimized from TLC to HPLC include bupivacaine hydrochloride, injectable bupivacaine hydrochloride, and triprolidine hydrochloride. (3) For sodium cefazolin, the new Pharmacopoeia has added control of the cefazolin dimer as a related-substances test, with a limit of 0.1%; similar cases include ubenimex, anastrozole, and others.

4.2 Strengthening Control of Genotoxic Impurities

In recent years, nitrosamine impurities—such as N-nitrosodimethylamine (NDMA) and N-nitrosodiethylamine (NDEA)—have been successively detected in sartan APIs and in ranitidine APIs and formulations, drawing widespread attention within the industry. To ensure drug safety, the latest edition of the Pharmacopoeia has introduced additional manufacturing requirements into the quality standards for sartan APIs—including valsartan, telmisartan, losartan potassium, irbesartan, candesartan cilexetil, and aliskiren fumarate—to emphasize that R&D and manufacturing enterprises must effectively control genotoxic impurities such as N-nitrosodimethylamine (NDMA) and N-nitrosodiethylamine (NDEA) that may arise during manufacturing processes, and comply with the relevant guidance issued by China’s drug regulatory authorities or with the ICH M7 guideline. In addition, the new edition of the Pharmacopoeia has added requirements for evaluating manufacturing processes for sulfonate-containing drugs—such as pefloxacin mesylate and sulbactam tosylate—to strengthen control over alkyl sulfonate genotoxic impurities in these products.

4.3 Strengthening the Control of Inorganic Impurities in Pharmaceuticals

Inorganic impurities can directly affect the purity and stability of pharmaceutical products; therefore, their detection and control must be given due attention. The latest edition of the Pharmacopoeia has accordingly strengthened the research and revision of methods for the determination of inorganic impurities in drugs. For example: (1) Fludarabine Phosphate: Since sodium salts are used in the synthetic process, the atomic absorption method has been enhanced to include the examination and control of sodium salts. (2) Metronidazole Injection, Metronidazole Glucose Injection, and Metronidazole Sodium Chloride Injection: Because these preparations are prone to forming nitrite degradation products during storage, which pose a potential risk to human safety, a test for nitrites has been added, using ion chromatography for quantification. Compared with the derivatization method employed in foreign pharmacopoeias, this approach is more accurate and specific, and it also avoids the use of toxic derivatizing reagents. (3) Zaleplon: As ethylating agents (bromoethane or iodoethane) are used in its synthesis, inorganic halides are easily formed; accordingly, the examination and control of halides have been strengthened, with a strict limit of 0.01%. (4) L-carnitine: Given that cyanide is used in its synthetic process, a test for cyanide has been added, with a limit of 5 ppm.

4.4 Strengthening the Harmonization of Microbial Limit Tests and Sterility Testing Methods and General Rules

Microbial limit tests and sterility tests are critical quality attributes that directly affect the safety of pharmaceutical preparations. To minimize the workload of drug-testing institutions during routine supervisory inspections, starting with the 2010 edition of the Chinese Pharmacopoeia, certain entries have added sterility or microbial limit test requirements. However, for some products, separately listing these two tests in the main text provides no practical reference value for testing and may introduce additional risks. In order to align with the methodological changes for sterility and microbial limits introduced in Volume Four of the new edition of the Pharmacopoeia [5], the corresponding provisions for sterility and microbial limits in the product monographs were standardized or revised during the compilation of the new Pharmacopoeia—for example, the sterility test method is no longer specified in the monographs for tegafur injection and cyclophosphamide for injection, but instead is conducted in accordance with the general rules; furthermore, the unit expression for microbial limits in gelatin has been revised to comply with the general rules.

4.5 Further Strengthening Safety Controls for High-Risk Varieties

The new edition of the Pharmacopoeia further strengthens safety controls for high-risk drug products. For example: (1) Enhanced control is applied to critical quality-control parameters for injectable preparations, such as pyrogens or bacterial endotoxins and particle size. In this edition, the newly added product mesna injection has had its registration standard for pyrogens or bacterial endotoxins uniformly revised to a bacterial endotoxin test, thereby improving the accuracy and sensitivity of the method; moreover, in accordance with the reference-standard specifications, the limit for bacterial endotoxins has been lowered from 0.125 EU·mg−1 to 0.03 EU·mg−1, thus reinforcing pharmaceutical safety control. For fat emulsion for injection (C14–24), a laser scattering particle-size analyzer based on Mie scattering theory has been introduced to detect particles larger than 5 μm, further ensuring the safety of clinical use. (2) Ophthalmic preparations, being directly administered to the eye to exert therapeutic effects, are subject to even stricter quality and safety requirements than other topical formulations. For instance, an excessively high or low pH in eye drops may cause ocular irritation; likewise, if the osmotic pressure is outside an appropriate range, it can lead to discomfort. Therefore, these two parameters must be rigorously controlled. In the new Pharmacopoeia, the pH range for hydroxybenzylazol hydrochloride eye drops has been revised from 3.0–5.0 to 3.5–5.0, and osmotic-pressure control has been added for brimonidine tartrate eye drops. In addition, given growing concern about the safety of preservatives used in ophthalmic preparations, the new Pharmacopoeia has further tightened controls on preservatives. For example, different manufacturers of bendazol eye drops employ different preservatives—ethylparaben, benzalkonium chloride, or thimerosal—and the new Pharmacopoeia has accordingly added specific tests for these preservatives to the monograph, with the annotation “The label or instructions for use of this product shall indicate the amount of preservative,” thereby facilitating compliance with the standard. (3) For biochemically derived drugs of animal origin, due to their complex sources and unclear compositional profiles, quality standards alone are insufficient to effectively control product quality. The new Pharmacopoeia has therefore strengthened controls over the sources of raw materials and manufacturing processes for such biologics, in order to better ensure their safety. For example, for viper venom thrombin, the manufacturing requirements now stipulate that the production process must comply with the current edition of the Good Manufacturing Practice for Pharmaceuticals, and a standard for the source of the raw material—viper venom—is also included as an annex, thereby enhancing control over the species origin and quality of the venom used as a raw material.

The new edition of the Pharmacopoeia further strengthens research on the characteristics of different dosage forms, establishes scientifically sound and rational testing methods for evaluating the efficacy of pharmaceutical preparations, and refines the correlation between clinical efficacy endpoints and quality-control parameters as well as the corresponding control requirements. The pharmacopoeial standards pertaining to drug efficacy include identification tests, assays for assay or potency, component analysis, polymorphism determination, content uniformity, dissolution and release testing, and other tests relevant to the specific characteristics of each dosage form.

5.1 Further Optimization of Assay Methods for Content and Potency

The 2020 Edition of the Chinese Pharmacopoeia has optimized methods for assay or potency determination and tightened limit requirements, which is of great importance in ensuring product efficacy. For example: (1) In the original monograph for erythromycin estolate, the assay was specified as “calculated on an anhydrous basis, the content of erythromycin estolate (C42H78N2O14) shall be 96.0%–102.0%”; the revised edition now states: “calculated on an anhydrous basis, the content of erythromycin estolate (C42H78N2O14), expressed as the sum of 16R-erythromycin estolate and 16S-erythromycin estolate, shall be 96.0%–102.0%,” thereby making the assay calculation more scientifically sound and consistent with the United States Pharmacopeia and the European Pharmacopoeia. (2) In the assay for hyaluronidase, determinations of protein content and specific activity have been added. (3) For viper venom thrombin, molecular weight is now determined by electrophoresis, and the molecular weight range has been narrowed from 36,000 (±5,000) daltons to 36,000 ± 3,000 daltons.

5.2 Incorporation of the Outcomes of Drug Consistency Evaluation in the Standards

With the ongoing evaluation of pharmaceutical quality and therapeutic equivalence, the findings of such evaluations must be incorporated into the pharmacopoeial quality standards for the corresponding dosage forms to enhance the scientific rigor and practical applicability of these standards. For example: (1) Revision of the pharmacopoeial specification for azithromycin for injection: Both Pfizer’s and PLIVA’s azithromycin for injection are designated as reference preparations, and both products are manufactured with an 8% overfill. Given that several domestic products have already passed the bioequivalence assessment for generic drugs, the content limit for azithromycin for injection should be revised to include the following provision: “For products manufactured with an overfill, calculated on the basis of the average fill weight, the content of azithromycin (C38H72N2O12) shall be 101.0% to 115.0% of the labeled amount.” (2) Revision of dissolution testing methods: For such products as amoxicillin capsules, potassium chloride sustained-release tablets, and lisinopril tablets, several domestic products have already been approved following the bioequivalence assessment for generics; therefore, the pharmacopoeial dissolution testing methods should be revised in accordance with the reference-listed product standards or the registration standards that have been validated through the bioequivalence assessment.

5.3 Expanding the Application of Modern Analytical Techniques in the Control of Formulation Efficacy Tests

The 2020 Edition of the Chinese Pharmacopoeia further expands the application of new technologies and methodologies in assay-related quality control tests for pharmaceutical preparations, such as content determination and identification, thereby enhancing the specificity, accuracy, and stability of these assays. For example, the method for determining the content of ganciclovir capsules has been revised from spectrophotometry to ion-exchange chromatography; the methods for cilostazol tablets and letrozole tablets have been revised from spectrophotometry to high-performance liquid chromatography, with the addition of systematic validation studies to ensure method specificity. In addition, the new edition of the Pharmacopoeia continues to introduce highly specific methods for drug identification and expands the use of infrared spectroscopy in the identification of pharmaceutical preparations. For instance, capecitabine tablets are identified by comparing their infrared absorption spectra within the wavenumber range of 1,500–1,760 cm⁻¹ with those of the reference standard, ensuring spectral consistency.

With the increasing maturity and widespread application of modern analytical techniques such as chromatography, the original format of the National Pharmacopoeia can no longer meet users’ needs, as evidenced by issues such as a lack of clear hierarchical structure in certain entries. Consequently, the Outline for the Preparation of the 2020 Edition of the Chinese Pharmacopoeia [6] explicitly includes pharmacopoeial format optimization as a key component. To date, both the United States Pharmacopeia (USP) and the British Pharmacopoeia (BP) have completed format revisions, with the new formats largely aligned: for instance, in the “Related Substances” section, individual sub-items such as chromatographic conditions, system suitability requirements, and sample preparation methods are listed separately, ensuring clarity and conciseness. However, this approach results in a greater number of entries that are somewhat fragmented, which poses challenges for Chinese typesetting, and the language is overly concise, potentially hindering comprehension and operational efficiency among testing personnel. Therefore, the format optimization of the Chinese Pharmacopoeia draws on the revised formats of the USP and BP while also taking into account the familiar usage patterns of Chinese Pharmacopoeia users; the textual descriptions continue to follow those of Volume II of the 2015 edition, but longer entries have been divided into separate sections. The format optimization primarily covers identification (using chromatographic methods), tests (including related substances, residual solvents, dissolution and release testing, and other items assessed by chromatography), assay (using chromatographic methods), and other complexly described items. For example, in chromatographically based identification, related substances, and assay entries, the new format comprises five main sections: solution preparation, chromatographic conditions, system suitability requirements, assay procedure, and limits or result interpretation; whereas dissolution and release testing is organized into six sections: dissolution conditions, solution preparation, chromatographic conditions, assay procedure, system suitability requirements, and limits or result interpretation.

While the format of the Pharmacopoeia has been optimized, the principles governing cross-referencing among different monographs have been further standardized. For example, a dosage form may reference the method for its active pharmaceutical ingredient; however, methods for different salt or anion compounds shall not be cross-referenced. Within the monographs for active pharmaceutical ingredients and dosage forms, identical test items may be cross-referenced; but when dosage forms share the same analytical method, such methods shall not be cross-referenced among themselves. In principle, assay methods are to be referenced for content determination, while dissolution and content uniformity tests are to be referenced to assay methods.

The new edition of the Pharmacopoeia has streamlined the format of 2,387 entries. Going forward, national pharmaceutical standards will also be progressively refined in accordance with the format of the new Pharmacopoeia during their development and revision. Following these format optimizations for both the Pharmacopoeia and national standards, the logical structure of the standards has been further enhanced, thereby improving user convenience.

The new edition of the Pharmacopoeia, while ensuring the controllability of drug quality, strengthens environmental protection requirements for standard methods and enhances safety protections for personnel performing these assays. For example: (1) Research has been conducted to develop alternative methods that replace organic mercury in standard procedures, thereby addressing and preventing environmental pollution. For instance, the revised non-aqueous titration method for hydroxymethazoline hydrochloride and hydroxybenzylhydrochloride APIs now employs potentiometric endpoint detection, eliminating the need for mercuric acetate as used in the previous method; similarly, the identification of lacidipine by liquid chromatography has replaced the original method’s chemical reaction-based identification using the toxic reagent mercuric oxide. (2) The use of other toxic reagents in standard methods is being avoided. For example, the 2015 edition of the Chinese Pharmacopoeia employed strychnine sulfate as the marker substance in the montmorillonite adsorption capacity test; however, since strychnine sulfate is classified as a Class A highly toxic substance and is currently not produced domestically, China has long relied on imports. The new edition revises this procedure to use tris(ethylenediamine)cobalt(III) as the marker substance instead of strychnine sulfate, which offers advantages such as non-toxicity, low cost, and easy availability. (3) Safety reminders are being added to the standards to enhance protection for testing personnel. For example, the standards for fludarabine phosphate and fludarabine phosphate for injection now include the safety warning: “This product has potential cytotoxicity; avoid inhalation of dust or direct skin contact”; similarly, the standards for actinomycin D and actinomycin D for injection now include the safety warning: “Care should be taken to avoid inhalation and skin contact with actinomycin.”

The 2020 Edition of Volume II of the Chinese Pharmacopoeia is guided by clinical needs, aligned with international advanced standards, and adopts a strategy that combines enhancement with phasing out. Over a five-year period, the standard-setting process for Volume II has become more rigorous, the selection of pharmaceutical entries more rational, the format and presentation more optimized, alignment with international standards further strengthened, and the mechanism for developing standards more scientific and comprehensively refined. Nevertheless, the new edition still requires improvement in certain areas: for instance, the number of chemical drug entries included remains insufficient, and there is still a need to expand coverage to encompass the National Essential Medicines List and the National Reimbursement Drug List. In addition, industry participation in the development and revision of the Pharmacopoeia and national standards remains low, underscoring the need to further enhance the applicability and enforcement of these standards.

In summary, Volume II of the 2020 Edition of the Chinese Pharmacopoeia has further strengthened its pivotal role as the national standard for pharmaceuticals, laying a solid foundation for comprehensively enhancing drug quality and providing critical technical support in accordance with the requirements set forth in the 2020 Pharmacopoeia Compilation Outline [6]. This development is of great significance for ensuring the safety and efficacy of medicines used by the public, as well as for advancing the upgrading of the pharmaceutical industry and improving drug quality.

References

[1] Pharmacopoeia of the People’s Republic of China, 2020 Edition, Volume II [S]. 2020

ChP 2020. Vol. II [S]. 2020

[2] National Health Commission of the People’s Republic of China. Notice on the Issuance of the National Essential Medicines List (2018 Edition), Document No. Guowei Yaozhengfa [2018] No. 31, http://www.nhc.gov.cn/yaozs/s7656/201810/c18533e22a3940d08d996b588d941631.shtml.

[3] National Healthcare Security Administration, Notice of the National Healthcare Security Administration and the Ministry of Human Resources and Social Security on Issuing the “National Basic Medical Insurance, Work Injury Insurance, and Maternity Insurance Drug List,” Document No. 46 [2019] of the National Healthcare Security Administration, http://www.nhsa.gov.cn/art/2019/8/20/art_37_1666.html.

[4] Pharmacopoeia of the People’s Republic of China, 2015 Edition, Volume II [S]. 2015

ChP 2015. Vol. II [S]. 2015

[5] Pharmacopoeia of the People’s Republic of China, 2020 Edition. Volume IV [S]. 2020

ChP 2020. Vol. IV [S]. 2020

[6] Notice of the National Pharmacopoeia Committee on the Release of the Outline for the Preparation of the 2020 Edition of the Chinese Pharmacopoeia. 2018 [EB/OL] http://www.chp.org.cn/view/ff8080815e0d584f01614671d79d5753?a=tz.

(Manuscript received: June 15, 2020)