Pefots

Legislative News

Germany granted the first traditional herbal medicinal product registration

German has granted the first traditional herbal medicinal product registration in the EU since the Directive on Traditional Herbal Medicinal Products came into force in April 2004. The registered traditional medicine is in liquid form consisting of 13 active herbal substances. Many of the ingredients such as ginger, clove flower, galangal, black pepper, nutmeg, dried bitter-orange, cinnamon bark and cardamom fruit are also used in TCM.

British Pharmacopoeia to include Chinese herbs

The British Pharmacopoeia Commission has initiated the development of new monographs for Chinese herbs. Known manufacturers have been invited to co-operate with the British Pharmacopoeia Secretariat in the development of these monographs for publication. The Chinese herbs proposed to be included in the British Pharmacopoeia are:
Bai Shao Yao (Paeoniae alba radix), Bai Zhu (Atractylodis macrocephalae), Ban Xia (Pinelliae rhizoma preparata), Chai Hu (Bupleuri radix), Chen Pi (Citri reticulatae pericarpium), Chuan Xiong (Ligustici wallichii rhizoma), Dan Shen (Salviae miltorrhizae radix), Dang Gui (Angelicaes sinensis radix), Dang Shen (Codonopsis pilosulae radix), Fu Ling (Poria cocos), Gan Cao (Glycyrrhizae radix), Gou Qi Zi (Lycii chinensis Frutus), He Shou Wu (Polygoni multiflori radix), Huang Qi (Astragali radix), Huang Qin (Scutellariae radix), Mu Dan Pi (Moutan radicis cortex), Shan Yao (Dioscoreae radix), Shen Di Huang (Rehmanniae glutinosa radix), Suan Zao Ren (Ziziphi spinozae semen), Yi Yi Ren (Coicis semen).

Draft of traditional medicines model released in the US

According to the American Herbal Products Association (AHPA), nine national organizations working together as the Traditional Medicines (TM) Congress have released the first public draft of "A Proposed Regulatory Model for Traditional Medicines: Guiding Assumptions and Key Components." This comprehensive document presents ideas for a new model for the regulation of traditional medicines in the U.S., and will now be subject to an open review process by interested individuals and organizations.

The genesis of this model goes back to 2004 when AHPA joined eight other organizations to exchange ideas about the future of traditional medicines in the U.S. These discussions culminated in the formation of the TM Congress. In seeking to emphasize both the value of traditional medicines and the responsibilities that are associated with their use, it was agreed that: The goal of the Traditional Medicines Congress is to benefit public health by ensuring access to traditional medicines in a manner that provides a reasonable expectation of public safety.

"The current legal framework for dietary supplements provides significant options for consumer healthcare choices," noted AHPA President Michael McGuffin. "And while some goods that have long been used as traditional medicines fit neatly into this framework, the therapeutic uses of these are restricted and many are entirely excluded. The model proposed here would completely protect the current law, while developing a new option that will benefit marketers who want to sell traditional medicines and practitioners and consumers who want to use them." Anyone with an interest in traditional medicines is now invited to review the draft document that the TM Congress has developed. A Proposed Regulatory Model for Traditional Medicines is posted online at AHPA's website, www.ahpa.org. The deadline for comments is March 31st.

China bans the sales of herbs of Aristolochia origin

China's State Food and Drug Administration (SFDA) issued a decree on 5 August 2004 to withdraw the pharmacopoeia monographs of two herbs of Aristolochia origin, i.e. Guang Fang Ji (Radix Arisctolochiae Fangchi) and Qing Mu Xiang (Radix Aristolochiae). As from 30 September 2004, all herbal formula and herbal products containing Guang Fang Ji must be replace by Fang Ji (Radix Stephaniae Tetrandrae), Qing Mu Xiang must be replaced by Tu Mu Xiang (Radix Inulae).

Warnings must be printed on the leaflets and packages of the products that contain the following four herbs of Aristolochia origin, Ma Dou Ling (Fructus Aristolochia), Xun Gu Feng (Herba Aristolochiae Mollissimae), Tian Xian Teng (Herba Aristolochiae) and Zhu Sha Lian (Radix Aristolochiae Kaempferi). Contents of the warnings include (1) This product contains Aristolochia herbs that contains aristolochic acid, which can cause damages to the kidneys; (2) This products is a prescription only medicine that can only be purchased with a prescription of a medical doctor. It should be used under the supervision of medical professionals. Kidney functions should be monitored when using this product and it should be immediately discontinued when abnormal kidney functions are detected; (3) It should used with caution for children and seniors. It is contraindicated for pregnant women, infants and those with kidney problems.

Another herb Guan Mu Tong (Caulis Aristolochiae Mancuriensis) had been withdrawn in 2003 and was replaced by Mu Tong (Caulis Akebiae).

Chinese Pharmacopoeia 2005

The 8th edition of the Pharmacopoeia of the People's Republic of China, or more commonly known as Chinese Pharmacopoeia 2005, came into effect on 1 July 2005. There are major revisions in this edition of the Chinese Pharmacopoeia.

Three herbs derived from Aristolochia species, i.e. Guan Mu Tong (Caulis Aristolochiae Manshuriensis), Guang Fang Ji (radix Aristolochiae Fangchi) and Qing Mu Xiang (Radix Aristolochiae) are withdrawn. To replace Guan Mu Tong, Mu Tong (Caulis Akebia) which is believed to be the original source of Mu Tong, is restated in this new edition as the legitimate source of Mu Tong. Caulis Akebia also replaces Caulis Aristolochiae Manshuriensis in formulas such as Long Dan Xie Gan Wan that used to contain Guang Mu Tong.

In another interesting development, a western herb, i.e. St. John's Wort is included in this edition of the Chinese Pharmacopoeia under the entry of Herba Hyperici Perforati (Guanyejinsitao). However, no TCM temperature and taste properties are given to this herb, nor is channel tropism.

There are also considerable revisions and improvements to the General Notices, Requirements of Monographs, General Requirements for Preparations in Appendices and new testing methods. The contents of Appendices are revised to large extent in comply with international standards for drug quality control. Furthermore, stylistic rules and layout, wording, units, and symbols are also standardized.

The Chinese Pharmacopoeia 2005 is published in three volumes. Volume I contains monographs of Chinese materia medica and prepared slice, vegetable oil/fat and herb extracts, Chinese traditional patent medicines, single ingredient of Chinese crude drug preparations. Volume II deals with monographs of chemical drugs, antibiotics, biochemical preparations, radiopharmaceuticals and excipients for pharmaceutical use. Volume III contains biological products. The Requirements for Biologics of the People's Republic of China is now incorporated into the Chinese Pharmacopoeia for the first time.

The increase in the number of monographs in Chinese Pharmacopoeia 2005 is obvious which contains up to 3214 monographs of drugs, with 525 new admissions in total. Volume I contains 1146 monographs, with 154 new admissions and 453 revised monographs. Volume II deals with 1967 monographs, with 327 new admissions and 522 revised monographs. Volume III contains 101 monographs, with 44 new admissions and 57 revised ones. The monographs in Appendices common to all the three volumes are presented in each volume respectively in a harmonized and unified form.