Anthroposophic Medicinal Products: A Literature Review of Features, Similarities and Differences to Conventional Medicinal Products, Scientific and Regulatory Assessment.

Background: Regulatory assessment of anthroposophic medicinal products (AMPs) can be challenging due to their specific features. Objective: The aim of this paper is therefore to provide adequate scientific information on AMPs for regulatory purposes. Methods: A literature review was executed with database searches in PubMed, Cinahl, Merkurstab, Anthromedics, and https://iaap-pharma.org/. Search terms were: anthroposophic medicinal products, anthroposophic medicines, anthroposophic pharmacy. There was no language restriction; searches were executed from onset until June 11, 2020. In addition, experts were invited to suggest relevant literature. Results: Eighty-seven of 660 identified publications were included. The system of anthroposophic medicine (AM) with its conceptual background and various aspects of AMPs was described: definition, pharmaceutical properties, an example of AMP development, use in clinical practice, similarities with and differences to conventional medicinal products, societal aspects, scientific and regulatory assessment. Conclusion: AMPs are part of the integrative whole medical system of AM. AMPs are manufactured according to Good Manufacturing Practice and national drug regulations and have an excellent safety status; the limited available evidence suggests clinical benefits. Current drug regulation of AMPs in the EU and most European countries does not take the special properties of AMPs into account. Future research should focus on appropriate methodologies for the evaluation of effects of AMPs as part of the AM whole medical system, the scientific quality of its non-atomistic holistic ontological position, and the integration of AM and conventional medicine in clinical practice. Future policies should focus on appropriate ways of addressing regulatory challenges to AMPs.

CHINA PH ARMACY Volume 33，Number 16，August 30，2022 Semimonthly Table of Contents Analysis of trans-provincia l distribution supervisio n of TCM decoction pieces in accordance with provincial standards from the perspective of benefit and risk / 中国药房

OBJECTIVE To provide ideas for solving the dispute of trans-provincial distribution of traditional Chinese medicine （TCM） decoction pieces in accordance with provincial standards （hereinafter referred to as “local TCM decoction pieces”）. METHODS Through simulation scenarios and collecting actual cases ，the conditions of trans-provincial distribution of local TCM decoction pieces were listed ；the official websites were searched or relevant personnel of drug supervision were interviewed；the current situation of trans-provincial distribution supervision of local TCM decoction pieces in China were sorted out. Based on the stakeholder theory ，the benefits and risks of main stakeholders were discussed to put forward relevant suggestions from the perspective of benefit /risk balance. RESULTS & CONCLUSIONS The conditions of trans-provincial distribution of local TCM decoction pieces in China included enterprises in B province produced TCM decoction pieces according to the A provincial standards，sold and used them in A province ；enterprises in B province produced TCM decoction pieces according to the B provincial standards ，sold and used them in A province ；enterprises in B province produced TCM decoction pieces according to the C provincial standards ，sold and used them in A province. At present ，there are no clear relevant provisions of national laws about trans-provincial distribution supervision of local TCM decoction pieces. Local regulatory opinions mainly come from the reply of the official website of drug regulatory department to online consultation ，and only Shandong ，Shanghai，Liaoning and Jiangxi have issued replies or normative documents. Totally 41.9％，38.7％ and 32.3％ of the provinces respectively allow the trans-provincial distrbution of local TCM decoction pieces in the above 3 conditions；in addition ，32.3％，16.1％ and 22.6％ provinces have unclear regulatory attitudes towards the 3 conditions. The benefits and risks analysis of relevant stakeholders shows that it is more in line with the scientific regulatory concept of benefit/risk balance to conditionally allow trans-provincial distribution of local TCM decoction pieces ，but the regulatory effect depends on the scientificity of the regulatory strategy. It is suggested that the drug regulatory departments clarify the relationship between the national and local standards for TCM decoction pieces and dingrl375@163.com differentiate the varieties of collection ；clear the regulatory requirements for trans-provincial distribution of local TCM decoction pieces by issuing high-level legal d ocuments；enrich regulatory measures and means ，and gradually adjust the requirements of trans-provincial distribution of local TCM decoction pieces .

Assesment of Adulterated Traditional Chinese Medicines in China: 2003-2017.

Traditional Chinese medicines (TCMs) represent one form of complementary and alternative medicine. The popularity and complexity in production make them attractive and vulnerable to adulteration in stages ranging from planting to production. Adulteration refers to the addition of extraneous, improper, or inferior ingredients that should not be present in TCMs. To detect and combat adulterated TCMs, supplementary testing methods (STMs), which expand the capability of routine testing standards, have been applied in China since 2003. From 2003 to 2017, a total of 184 STMs for TCMs were approved by the Chinese national drug regulatory authority. By assessing these STMs, this research intends to identify those TCMs vulnerable to adulteration, to list common adulterants, and to characterize the techniques of analysis. The results show that adulteration of TCMs can be classified into three main categories: the addition of undeclared drugs/chemical substances, substitution with non-drug components, and the addition of foreign non-drug materials. The top five therapeutic areas of TCMs vulnerable to adulteration are diabetes, calm and sleep, sexual dysfunction, pain relief, and rheumatism. A total of 166 adulterants were detected in the adulterated TCM preparations and herbal products studied here, with 158 adulterants in TCM preparations and 43 in herbal products, with 35 adulterants in common. Each STM consists of different pharmaceutical analysis techniques, including tests for physical-chemical properties, chromatography, spectroscopic techniques, and mass spectrometry. The analytical methodology of STMs relies on the combination of these techniques, with HPLC ranking the highest percentage (76.1%) and physical-chemical techniques the lowest percentage (11.4%). This research shows that STMs have played a crucial role in combating adulterated TCMs. However, STMs represent merely a product testing-centered regulatory strategy. The inspection of cultivation and manufacturing processes should also be strengthened. More importantly, the awareness and self-discipline of TCM manufacturers in implementing good manufacturing practices and regulating the planting and cultivation of raw materials should be improved.

Common Herbal-pairs Summary in Treating Lung Cancer by Professor Shu Qijin / 浙江中医药大学学报

Objective] To summarize the experiences of Professor Shu Qijin and to introduce his frequently used traditional Chinese medicine(TCM) herbal-pairs for treating lung cancer. [Methods] Professor Shu's experience and the treatment principles on herbal-pairs were summarized by attending the process of his diagnosis and treatment for lung cancer patients and his medical records. [Results] Shu treated that lung cancer by traditional Chinese medicine belongs to the multi-target therapy, drug although short, lung disease is also complex. However, the drug for lung cancer a target in strong, if properly combined, can hold simplification, observant insight. For advanced lung cancer patients with Qi deficiency symptoms, Shu used common heterophylla-Astragalus, Codonopsis-white atractylodes rhizome, Radix Glehniae, Ophiopogon japonicus, medicine of Fuzheng anticancer; sputum is a poison stasis, Shu divided common diffusa-sheliugu, Lobelia chinensis, Scutellaria barbata, Taxus chinensis var. mairei, Polygonum cuspidatum root medicine for detoxification Sanjie; blood stasis, Shu used common trigonous, rhizome, notoginseng, radix paeoniae rubra, etc. drug for promoting blood circulation and removing blood stasis. Anyway, Shu permited the treatment of lung cancer, on the basis of dialectical argumentation, discerning the pathogeny, disease location, disease, illness and mastering five flavors of the four properties of traditional Chinese medicine(TCM), rising and sinking, using the following drugs, clinical addition and subtraction, herbal prescription has better clinical efficacy, and attached with the case of a post-mortem. [Conclusions]Medicine of precise curative effect is determined by Shu and the mechanism of medication has higher clinical value,it is worth in-depth study and application.

[The costs of new drugs compared to current standard treatment]. / Die Preise neuer Arzneimittel im Vergleich zu ihren therapeutischen Alternativen.

BACKGROUND: Until AMNOG came into effect Germany had free pricing of new drugs. Our exemplary work investigates the costs of new drugs that were licensed in the two years prior to AMNOG, and compares them to the costs of standard treatment that has been used in pivotal trials. Also, the important components of pharmaceutical prices will be illustrated. METHOD: We retrospectively analysed the European Public Assessment Reports of proprietary medicinal products that the European Medicinal Agency initially approved in 2009 and 2010 and that were tested against an active control in at least one pivotal trial. RESULTS: If the standard treatment was a generic, the average pharmacy retail price of new drugs was 7.4 times (median 7.1) higher than that of standard treatment. If the standard treatment was an originator drug the average price was 1.4 times (median 1.2) higher than that of the new drug. There was no clear correlation of an increase in costs for new drugs and their "grade of innovation" as rated according to the criteria of Fricke. Our study shows that prices of new drugs must be linked to the evidence of comparative benefit; since German drug pricing is complex, cost saving effects obtained thereby will depend on a range of other rules and decisions.