Herbal medicines quality requirements

Licensed herbal medicines To receive a product license prior to marketing, herbal medicines are required to meet safety, quality, and efficacy criteria in a similar manner to any other licensed medicine. 

It is one of the peculiarities of herbal drugs that their indications have for the most part been determijied empirically. The reason is easily understood most herbal drugs have been used for a very long time to alleviate or cure illnesses and more especially disorders. Their introduction in therapeutics happened at a time when pharmacodynamics and pharmacokinetics were unknown concepts, when there was no Medicines Act to require proof of the quality, efficacy, and innocuity of herbal medicines. Today, when introducing a new medicine, extensive investigations are required in the interest of safety. To many the requirement of the proof of activity of such a drug as chamomile appears to be superfluous, but nevertheless, as a representative of a scientifically oriented pharma-... 

Just like all herbal medicinal preparations, C. sativa should be standardized if extracts or whole plant material are to be used for medicinal purposes. Basic requirements are that all detectable constituents should be known, but also a sustainable quahty control system must be established to achieve the same quahty over all batches. For industrial use of cannabis, standardization could also be necessary to equahze the quality of the product. However, it must be stated that cultivation for this purposes is mostly performed outdoors. Outdoor growth makes standardization of the product difficult due to the environmental changes. For this reason the Dutch medicinal C. sativa is grown under strictly controllable conditions, and therefore indoors, by the company Bedrocan. At this company clones are used for breeding to maintain high standards for quantity and quality. After a strictly selective breeding procedure a plant fine has been estabhshed fulfilhng all criteria as a herb for medicinal use. 

A major contention of the herbal medicine advocacy is the notion that because these entities are natural products, they are somehow safer and better for human consumption. However, the vast majority of alternative medicine products are essentially unregulated and not yet required to demonstrate efficacy, safety, or quality before becoming commercially available. Currently, in the United States, there exists continued debate on what role the FDA should have in regulating and approving alternative medicines. ... 

Differences in criteria and methods of assessment of the characteristics and properties of herbal products may represent a risk for consumers and an obstacle to their free circulation within the Community. Therefore, in 1997, an ad hoc working group was established at the EMEA, which was tasked with addressing the problems of demonstration of quality, safety and efficacy. Subsequently the group became a permanent Working Party of the CPMP and developed a set of guidelines on the requirements and assessment of herbal medicines. 

The simplified procedure for registration of traditional herbal medicinal products includes full administrative information and a complete pharmaceutical dossier on the assumption that the quality of the product is independent of its traditional use. Nonclinical data are not necessary where information on the traditional use proves that the product is not harmful in the specified conditions of use. However, where concerns are raised with regard to the product s safety, the competent authorities may ask for additional data necessary to assess safety. The dossier will, therefore, include a bibliographic review of safety data, and additional data where required, together with an expert report. 

The supplementary guidelines are intended to provide WHO Member States with general and minimum technical requirements for quality assurance and control in the manufacture of herbal medicines. Each Member State should develop its own national GMP for manufacturing herbal medicines that are appropriate to the country s actual situation. 

Vitamin(s) and mineral(s), which could be ancillary substances in traditional herbal medicinal products for human use, should fulfill the requirements of the "Guideline on summary of requirements for active substances in the quality part of the dossier" (CHMP/QWP/297/97 Rev. 1 corr). 

In recent times, UPLC technique has routinely been performed for analysis of pharmaceutical formulations natural products foods and herbal medicines in various research institutes laboratories concerned with biochemistry, biotechnology, environmental analysis natural product research and several other research fields. For the analysis of foods, natural products, or medicines, analytical scientist need to extend their understanding to provide evidence-based validation and effectiveness to establish safety parameters for their production. Also, the rapid separation of samples is an analytical stage that requires high efficiency as well as speed due to the complexity of the sample matrix, and hence it is particularly challenging to achieve. UPLC provides high-quality separations and detection capabilities to identify active compounds in highly complex samples that result from natural products and analyzed foods. 

Few herbal medicinal products are on the market as authorised medicines in the EU, fulfilling the same stringent requirements that count for conventional medicinal products. This is largely due to the limited availability of randomised controlled trials to support the quality, safety and efficacy of herbal medicinal products. More often they are licensed as traditional herbal medicinal products, following an adapted and simplified registration wherein efficacy is made plausible based on available scientific data (well-established use) or long-term historic use in the EU (traditional use). Sufficient data to underpin the safety should be available in all cases and the quality of the herbal... 

The Ph. Eur. has legal force for both human and veterinary medicines. The Ph. Eur. has various monographs. More than half of all the monographs concern raw materials from chemical, herbal or animal origin. Raw materials that are used in the pharmacy for preparing medicines should be of a suitable standard. If medicines meet the quality requirements of the Ph. Eur. then they are of a suitable standard for patient use within any restrictions noted. 

Ganzera M (2008) Quality control of herbal medicines by capillary electrophoresis potential, requirements and applications. Electrophoresis 29 (Copyright (C) 2012 American Chemical Society (ACS). All Rights Reserved.) 3489-3503. doi 10.1002/elps.200700901... 

The identity and quality of herbal material, herbal preparations and of finished herbal products should be tested as described in the Quality control methods for medicinal plant materials (d). The minimum requirement for the technical equipment is for instruments to perform the tests described in (d). Moreover, each country should develop this basic requirement for technical equipment further, according to the country s needs. 

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