关于规范药品行政执法自由裁量权的思考

目的为正确使用药品行政监督自由裁量权提供参考。方法分析了自由裁量权的滥用风险和认识误区。结果与结论结合药品行政执法实践提出了规范自由裁量权的有关建议。     

论药品监督行政执法中的自由裁量权

本文叙述了自由裁量权的特点,概括了药品监督执法中自由裁量权的种类,总结了药品监督执法中滥用自由裁量权的表现形式,探讨了控制自由裁量权滥用的对策,目的是防止自由裁量权的滥用,提高药品行政执法水平.     

合理运用自由裁量权规范药品监督罚款幅度

当前,省以下药品监督管理部门担负着对药品、医疗器械、药品包装用材料和容器的研究、生产、经营和使用全过程的监督管理职能.行政自由裁量权的运用是该部门现代化行政中必不可少的权力,如行政许可、行政认可、行政处罚、行政奖励等等.     

药品行政处罚中自由裁量权的运用及其内部控制

通过阐述自由裁量权的形成及在药品行政处罚中的表现,进一步探讨药品行政管理机关如何加强对自由裁量权的内部控制,减少因"恣意裁量"而导致的行政复议和行政诉讼的发生.     

药品监管行政执法责任制初探

药品监督管理行政执法责任制的全面推行和完善,是药品监管机关、特别是地方省以下各级机关,强化药品监管行政责任,严格依法行政的重要保障措施.作为国家食品药品监督管理局确定的软科学研究项目的负责人,作者就执法责任制的相关制度和监督实施等问题进行探讨.     

药品监管行政执法责任制研究

论述全面推行和完善药品监督管理行政执法责任制对药品监管机关强化药品监管行政责任、严格依法行政的重要意义,并就执法责任制的相关制度和监督实施等问题进行探讨.     

探讨药品监督管理中行政自由裁量权的分类

以药品监督管理中行政自由裁量权为议题，概述行政自由裁量权存在的必要性及其现有分类的缺陷，探讨并提出自由裁量权的新分类方法，为规范和控制药品监督管理中的行政自由裁量权提供参考。     

药品行政监督中的自由裁量

随着我国法律制度的不断健全和社会法律意识的不断增强,药品行政监督中合法、合理地使用手中的自由裁量权也日显重要.药品行政监督的自由裁量权是指国家药品监督管理行政主体在法律、法规授权或许可的范围内,赋予行政的为达到目的而自主掌握、自主选择作出最为合适的具体行政行为的权力.行政机关自由选择的范围不仅限于决定的内容,也可能是执行任务的方法、时间、地点或侧重点,也包括不采取行动的决定在内.     

浅析药品监管行政处罚自由裁量权适用问题

药品监管行政自由裁量权是一把"双刃剑",合理运用能有效规范药品经营秩序,提高药品监管效率,不当行使则会损害群众利益,亵渎法律正义。随着药品监督执法工作的不断深入和人民群众法制观     

浅谈药品技术监督在药品行政执法中的重要作用

药品监督行政执法肩负着保证药品、医疗器械质量,维护人民用药、用械安全,为人民健康保驾护航的作用.药品技术监督是在药品监督管理部门领导下,通过检验和检查,对药品、医疗器械质量进行监督.     

如何避免造成药监行政处罚主要证据不足

《中华人民共和国行政复议法》第二十八条和《中华人民共和国行政诉讼法》第五十四条第（二）项分别规定，复议机关和人民法院经过审理，认定被审查的具体行政行为主要证据不足的，应决定或判决撤销或者部分撤销，并可以责令原处罚机关重新作出具体行政行为。但是，相应的法律法规对什么是具体行政行为主要证据不足的真正内涵，它具体的表现形式有哪些，以及如何把握行政处罚证据充分的基本要求等均未作规定。实践中，执法人员往往难以把握，行政处罚一旦经过复议被撤销或者产生诉讼造成败诉后，重新依法作出具体行政处罚的，既影响行政效能、浪费行政执法成本，又损害行政机关的威信。为此，笔者试结合药监执法实践，就药监执法人员如何避免造成主要证据不足，谈谈个人粗浅的看法。     

浅议如何确定药品行政处罚对象的主体资格

我国《行政处罚法》和相关法律，明确规定了行政处罚对象的主体资格，但是尚未对其进行细化，在执法实践中由于对法律法规条文理解不一，在一定程度上造成了难以确定行政处罚对象主体资格的情况。本文结合《行政处罚法》、《药品管理法》等相关法律法规，对如何确定行政处罚对象的主体资格进行探讨。     

Assessing Similarity to Existing Drugs to Decide Whether to Continue Drug Development

Developing a drug requires large investments, over many years, with dramatic increases in development costs at later stages. Thus, one wants to make a No Go decision on a compound early, unless evidence continues to suggest that the project will ultimately be successful, so that resources can be focused on the most promising compounds to benefit patients. Instead of predicting the probability of success of a Phase III study, our approach to this decision uses the Phase II study results to assess similarity of the novel compound to existing drugs that are classified by different decision categories, such as a clear Go decision (e.g., a clearly effective drug), a (unfortunately common) Not Sure decision (e.g., a potentially useful but not outstanding drug), and a clear No Go decision (e.g., a clearly not effective drug). We describe how this modeling can be done using both individual and binary endpoints and how results can be combined for several different endpoints. Potential extensions of the method are also discussed.     

Points to Consider when Establishing Drug Product Specifications for Parenteral Microspheres

Drug product specifications are a critical element of a good control strategy. Parenteral microsphere products are complex dosage forms, requiring careful development of test methods and acceptance criteria for the specifications. In particular, the in vitro release test method and acceptance criteria require rigorous scientific consideration and should be developed with an eye toward understanding the mechanisms of drug release. The final specifications need to ensure the safety, identity, strength, performance, and quality of the drug product at release and during storage through the end of its shelf-life. The specification limits are typically established based upon regulatory guidance, available data from the manufacturing process (process capability), from non-clinical, clinical, and stability studies.     

药品监督行政处罚中存在的问题与对策

本文从河北省药品监督执法的实际出发，研究分析了药品监管行政处罚中普遍存在的十个突出问题，同时提出了五个具体应对措施。     

如何对待中药安全性问题

从“马兜铃酸事件”到“含汞、砷中药安全性事件”，再到笔者亲历参与医疗事故鉴定的“云南白药中毒致死事件”，关于中药安全性问题的事件在近些年来频频发生。人们不仅要问，这一向自称为“安全、有效”的中药究竟出现了什么问题？作为执业药师的我们又应如何应对中药安全性问题？具体需从那些方面着手开展工作？为找寻以上问题的答案，笔者试图从国内外频繁发生的一系列中药安全性事件进行回顾、分析、探讨入手，就执业药师如何应对中药安全性问题提出看法，以供参考。     

How to Regulate Nonbiological Complex Drugs (NBCD) and Their Follow-on Versions: Points to Consider

The aim of this critical review is to reach a global consensus regarding the introduction of follow-on versions of nonbiological complex drugs (NBCD). A nonbiological complex drug is a medicinal product, not being a biological medicine, where the active substance is not a homo-molecular structure, but consists of different (closely related and often nanoparticulate) structures that cannot be isolated and fully quantitated, characterized and/or described by state of the art physicochemical analytical means and where the clinical meaning of the differences is not known. The composition, quality and in vivo performance of NBCD are highly dependent on manufacturing processes of both the active ingredient as well as in most cases the formulation. The challenges posed by the development of follow-on versions of NBCD are illustrated in this paper by discussing the ‘families’ of liposomes, iron–carbohydrate (‘iron–sugar’) drugs and glatiramoids. It is proposed that the same principles for the marketing authorization of copies of NBCD as for biosimilars be used: the need for animal and/or clinical data and the need to show similarity in quality, safety and efficacy. The regulatory approach of NBCD will have to take into consideration the specific characteristics of the drugs, their formulation and manufacturing process and the resulting critical attributes to achieve their desired quality, safety and efficacy. As with the biosimilars, for the NBCD product, family-specific methods should be evaluated and applied where scientifically proven, including sophisticated quality methods, pharmacodynamic markers and animal models. Concerning substitution and interchangeability of NBCD, it is also advisable to take biosimilars as an example, i.e. (1) substitution without the involvement of a healthcare professional should be discouraged to ensure traceability of the treatment of individual patients, (2) keep an individual patient on a specific treatment if the patient is doing well and only switch if unavoidable and (3) monitor the safety and efficacy of the new product if switching occurs.     

药品监督行政处罚中常见问题与对策

为切实提高基层监管执法水平,规范执法行为,提高办案质量,现将常见的问题总结如下,并提出相应的对策,希望能对基层药品监督执法工作有所帮助.     

论《行政诉讼法》在药政案件中的适用

本文根据《行政诉讼法》的有关规定,着重论述了我国药政案件的基本特征,药政诉讼与复议的关系,药政诉讼参加人,案件的管辖与受案范围.并列述了被告的诉讼权利与诉讼义务,以及药政违法行为的主要表现形式.     

Gastrointestinal Drug Absorption: Is It Time to Consider Heterogeneity as Well as Homogeneity?

The current analysis of gastrointestinal absorption phenomena relies on the concept of homogeneity. However, drug dissolution, transit and uptake in the gastrointestinal tract are heterogeneous processes since they take place at interfaces of different phases under variable stirring conditions. Recent advances in physics and chemistry demonstrate that the geometry of the environment is of major importance for the treatment of heterogeneous processes. In this context, the heterogeneous character of in vivo drug dissolution, transit and uptake is discussed in terms of fractal concepts. Based on this analysis, drugs are classified in accordance with their gastrointestinal absorption characteristics into two broad categories i.e. homogeneous and heterogeneous. The former category includes drugs with satisfactory solubility and permeability which ensure the validity of the homogeneous hypothesis. Drugs with low solubility and permeability are termed heterogeneous since they traverse the entire gastrointestinal tract and therefore are more likely to exhibit heterogeneous dissolution, transit and uptake. The high variability of whole bowel transit and the unpredictability of conventional dissolution tests for heterogeneous drugs are interpreted on the basis of the fractal nature of these processes underin vivoconditions. The implications associated with the use of strict statistical criteria in bioequivalence studies for heterogeneous drugs are also pointed out.