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This review illustrates some brief considerations of the medical use of cannabis recently issued in Italy. History and uses of cannabis throughout centuries and different countries are illustrated together with a description of botany and active phytocannabinoids. Then, medical use of cannabis anti-pain treatment for patients resistant to conventional therapies is described in case of chronic neuropathic pain, spasticity, for anticinetosic and antiemetic effect in nausea and vomiting caused by chemotherapy, for appetite stimulating effect in cachexia, anorexia, loss of appetite in cancer patients or patients with AIDS and in anorexia nervosa, hypotensive effect in glaucoma resistant to conventional therapies and for reduction of involuntary body and facial movements in Gilles de la Tourette syndrome. Italian most recent legislation on medical cannabis is detailed with some law proposals, also showing the inconsistent legislation within European Union. Some final considerations of future studies are also reported.

This paper assesses the current regulatory environment, relevant regulations and guidelines, and their impact on continuous manufacturing. It summarizes current regulatory experience and learning from both review and inspection perspectives. It outlines key regulatory aspects, including continuous manufacturing process description and control strategy in regulatory files, process validation, and key Good Manufacturing Practice (GMP) requirements. In addition, the paper identifies regulatory gaps and challenges and proposes a way forward to facilitate implementation., (© 2014 Wiley Periodicals, Inc. and the American Pharmacists Association.)

Background: Ten years have passed since Latvia became a Member State of the EU in 2004. As a result European regulations, including those related to rare diseases and orphan drugs, have been applied to Latvian legislative system. Orphan diseases have been recognized as a priority area for action in the public health system, though there are significant differences in the national healthcare services for rare diseases among the EU States. This study aims to determine situation in the field of rare diseases in Latvia and compare it with other European countries., Methods: We used the national plan for rare diseases, EUCERD reports, Orphanet data, Latvian and European regulations, publicly available data from the state agencies, and directly contacted drug manufacturers and wholesalers., Results: National plan for rare diseases was developed and approved in 2013. Although there are no official designated centers of expertise as well as no specific register for rare diseases. Newborns are screened for only two disorders: phenylketonuria and congenital hypothyroidism. Currently 34 orphan drugs are available on Latvian market. Three medicines (8.8%) are included in the reimbursement drug list, all indicated for Ph + CML. 15 drugs (44.1%) were reimbursed within the framework of individual reimbursement system, and five drugs (14.7%) were provided within the program of medicinal treatment of rare diseases in children., Conclusions: Majority of orphan drugs authorized in the EU are not available in Latvia, moreover those drugs that are available are often not accessible because they are insufficiently reimbursed. Besides, approval of the national plan might be an important step towards improving situation in the field of rare diseases.

Ethnopharmacological Relevance: Herbal drugs are gaining worldwide prominence due to their distinct advantages. Developing countries have started exploring the ethnopharmacological approach of drug discovery and have begun to file patents on herbal drugs. The expansion of R&D in Indian herbal research organizations and presence of manufacturing units at non-Indian sites is an indication of the capability to develop new products and processes. The present study attempts to identify innovations in the Indian herbal drug sector by analyzing the patenting trends in India, US and EU., Methodology: Based on key word and IPC based search at the IPO, USPTO, Esp@cenet and WIPO databases, patent applications and grant in herbal drugs by Indian applicants/assignees was collected for the last ten years (from 1st January 2001 to 31st October 2010). From this collection patents related to human therapeutic use only were selected. Analysis was performed to identify filing trends, major applicants/assignees, disease area and major plant species used for various treatments., Result: There is a gradual increase in patent filing through the years. In India, individual inventors have maximum applications and grants. CSIR, among research organizations and Hindustan Unilever, Avesthagen, Piramal Life Science, Sahajanand Biotech and Indus Biotech among the companies have the maximum granted patents in India, US and EU respectively. Diabetes, cancer and inflammatory disorders are the major areas for patenting in India and abroad. Recent patents are on new herbal formulations for treatment of AIDS, hepatitis, skin disorders and gastrointestinal disorders., Conclusion: A majority of the herbal patents applications and grants in India are with individual inventors. Claim analysis indicates that these patents include novel multi-herb compositions with synergistic action. Indian research organizations are more active than companies in filing for patents. CSIR has maximum numbers of applications not only in India but also in the US and EU. Patents by research organizations and herbal companies are on development of new processes for active compound isolation and standardization of such components in addition to new compositions for therapeutic use. Pharmaceutical companies such as Ranbaxy, Lupin and Panacea Biotec are increasingly patenting on herbal drugs. There is increased patenting activity related to diabetes, cancer, cardiovascular diseases, asthma and arthritis in India and abroad., (Copyright © 2011 Elsevier Ireland Ltd. All rights reserved.)

The use of genetically modified (GM) plants to synthesize proteins that are subsequently processed, regulated and sold as pharmaceuticals challenges two very different established regulatory frameworks, one concerning GM plants and the other covering the development of biotechnology-derived drugs. Within these regulatory systems, specific regulations and guidelines for plant-made pharmaceuticals (PMPs)--also referred to as plant-derived pharmaceuticals (PDPs)--are still evolving. The products nearing commercial viability will ultimately help to road test and fine-tune these regulations, and might help to reduce regulatory uncertainties. In this review, we summarize the current state of regulations in different countries, discuss recent changes and highlight the need for further regulatory development in this burgeoning, new industry. We also make the case for the harmonization of international regulations.

In accordance with the Regulation N 2309/93/EC, the Commission shall produce a synopsis of European registration operating procedures no later than 2001. On July 18, 2001, after a wide open consultation, the College of Commissioners adopted a Proposed Revision elaborated by the "DG Enterprises". This Proposed Revision was guided by the desire to facilitate access of citizens of the European Union to innovating and safe medications, to limit fragmentation of the interior market, prejudicial to the community pharmaceutical industry, and to prepare widening of the community. This synopsis focused essentially on registration procedures and pharmacovigilance, on patient information, on reform of the European agency for administrative protection of recorded data. The Proposed Revision is following the codecision procedure and should come into force, in a more or less amended form, at the end of 2004 at the latest.

The pharmacokinetic content of the drug registration file is now well standardized. The objectives of the pharmacokinetic documentation is to provide evidence supporting the dosing regimen in patients, to take into account the pathophysiological states of the populations at risk and to anticipate drug-drug interactions. Recommendations on study design and evaluation of parameters of interest are listed in various documents Issued by the Committee for Proprietary Medicinal Products and the International conferences on Harmonization, i.e. the Concept Papers, the Points to Consider and Notes for Guidance. The pharmacokinetic data of the registration file are used to document many sections of the Summary of the Product Characteristics.

A brief discussion of the history of the use of herbal medicines from prehistoric times to the mid-twentieth century precedes an explanation of why usage of such remedies in the United States declined in the 1940s but returned to popularity in the 1980s. The provisions of the Dietary Supplement Health and Education Act of 1994 are presented together with its perceived influence, both positive and negative, on the health of the American people. Possible futures of herbal medicines are considered. The negative viewpoint that they will ultimately be rejected is refuted, and the more optimistic prediction that herbs are ultimately destined to become a part of mainstream medicine is defended. Stumbling blocks to such acceptance are evaluated and methods of overcoming them suggested. The urgent need for the development of a sensible regulatory environment encouraging the approval of botanicals as drugs is emphasized. After predicting a bright future for rational phytomedicines, the author opines that many of them will eventually play significant roles in medicinal practice.

Safety pharmacology, a discipline unrecognized until the last few years, is now the subject of Japanese, American, European and ICH draft guidelines. The aim of these guidelines, either of a general nature or targeted at one particular organ, is to define the necessary pharmacology studies as well as the conditions in which these studies must be performed to ensure the safe use of new molecules when they are administered to man. This presentation attempts to give a comparative analysis of these documents and to place them in the context of future international harmonization.

The article describes the recent developments in drug treatment systems in several European countries. The article is based on the up-dated papers delivered in the closing meeting of the ISDRUTS-project (International Study of the Drug Treatment Systems) in Lisbon, October 7-9, 1998. In the article latest trends in drug situation and drug-related harm in different countries are represented. Also recent changes in legal measures, the proceeding of the harm reduction measures, the situation with heroin trials, the implosion of the drug treatment system into the alcohol treatment system and alternatives to imprisonment and other diversion mechanisms for addicts are described. In the concluding chapter recent trends in drug treatment are analysed in the framework of the political climate in Europe.