Registration Of New Products Research Articles

The Effects of Plant Growth-Promoting Bacteria with Biostimulant Features on the Growth of a Local Onion Cultivar and a Commercial Zucchini Variety

The reduction of chemical inputs due to fertilizer and pesticide applications is a target shared both by farmers and consumers in order to minimize the side effects for human and environmental health. Among the possible strategies, the use of biostimulants has become increasingly important as demonstrated by the fast growth of their global market and by the increased rate of registration of new products. In this work, we assessed the effects of five bacterial strains (Pseudomonas fluorescens Pf4, P. putida S1Pf1, P. protegens Pf7, P. migulae 8R6, and Pseudomonas sp. 5Vm1K), which were chosen according to their previously reported plant growth promotion traits and their positive effects on fruit/seed nutrient contents, on a local onion cultivar and on zucchini. The possible variations induced by the inoculation with the bacterial strains on the onion nutritional components were also evaluated. Inoculation resulted in significant growth stimulation and improvement of the mineral concentration of the onion bulb, induced particularly by 5Vm1K and S1Pf1, and in different effects on the flowering of the zucchini plants according to the bacterial strain. The present study provides new information regarding the activity of the five plant growth-promoting bacteria (PGPB) strains on onion and zucchini, two plant species rarely considered by the scientific literature despite their economic relevance.

Management model of the pharmaceutical enterprise competitiveness

Competition and Competitiveness (COP) of the enterprise are important in economic terms , acquires special importance in this era of globalization . High level of COP is the guarantor of high returns. Consequently, under the current model of socio— economic development of the Russian Federation issues COP occupy a dominant place in the theory of the national economy. Despite this, to date, there is no single generally accepted definition of «competitiveness ». An important characteristic of the COP of the company is its management model. Problem poses on industries in general, affect the approaches used in the management of the firms operating in these sectors. The specificity of the industry in which the company operates, may affect the impact of industry-wide problems at the individual enterprise. To this industry include pharmaceutical. Today’s economic situation for Russian companies in the pharmaceutical industry is characterized by a low level of innovation component, low-profit orientation on the production of products (generics) , difficulties in the creation and registration of new products that eventually forms a low competitiveness of not only individual enterprises, but also the entire industry . Because of the strong competitive pressure from the nearest neighbors — China, India and other countries, as well as presence in the market a large number of manufacturers of large multinational pharmaceutical corporations, the development of Russian pharmaceutical COP greatly complicated. Import volumes of medicines, pharmaceutical substances, pharmaceutical goods in recent years tend to increase. Pricing and competitive strategy , used by foreign producers adversely affects not only the individual Russian companies , but in general, a number of pharmaceutical and related ( chemical, biochemical ) industries. In this situation, one of the main levers of influence on the situation at the enterprise level is the management of the COP. Control mechanism for the formation of a proper level is necessary to introduce a certain model that decision-making could consider the impact of key factors. The authors offer their vision model management competitiveness pharmaceutical company in a highly competitive market saturation.

The use of indigenous ecological resources for pest control in Africa

Reducing the losses from crop pests will help to increase food availability and boost economic growth in sub- Saharan Africa (SSA). However, the existing crop protection paradigm that relies on synthetic agrochemical pesticides has had only a marginal impact on the productivity of many poor smallholder farmers who constitute a major segment of agri- culture in SSA. This is primarily because many of them are not able to afford or access these imported chemicals. A solution to this crop protection problem may be to harness biologicalresourcesthatarelocallyavailable,suchasendemic insect natural enemies and indigenous pesticidal plant mate- rials. Two specific examples of this already under develop- ment in Africa are the use of the pesticidal plant, Tephrosia vogelii, and the harvesting of the endemic insect baculovirus, Spodoptera exempta nucleopolyhedrovirus (SpexNPV). Both of these can be produced locally and have shown promise in trials as inexpensive and effective tools for pest control in Africa and their use is currently being scaled up and evaluated by African networks of researchers. A focus on these systems illustrates the potential for using locally-available natural re- sources for improved crop protection in Africa. The consider- ation of these pesticidal plants and insect natural enemies in the wider context of natural capital that provide valuable ecosystem services (including pest control), will facilitate greater recognition of their true economic and societal worth. While both of these model systems show promise, there are also very significant challenges to be overcome in developing production, supply and marketing systems that are economi- cally viableand sustainable.Theregulatoryenvironment must also evolve to accommodate and facilitate the registration of new products and the establishment of appropriate supply chains that share the benefits of these resources equitably with the local communities from which they are harvested.

Factors determining use of biological disease control measures by the avocado industry in South Africa

Farmers in the northern avocado cultivation areas of South Africa were interviewed concerning their experience and perceptions of biological control. Factors affecting their decision to use biological control programmes as a disease control strategy, were also investigated. Results indicate that educational level, age and land owner status reflect the farmer's decision making ability and the level of commitment to adopt the new technology. Generations of family farming and farm management systems that have adopted food safety management systems also had an influence on their willingness to explore biological control. Although most farmers were aware of biological control, most could not define it. Farmers did not blame biological control for the previous poor results, but rather on environmental factors and a lack of perseverance on their side with the use of the product. Land reform aims to redistribute 30 percent of the country's agricultural land from white commercial farmers to previously disadvantaged communities by 2014. Farmers on farms with completed or invalid land claims were more willing to utilise biological control than growers without claims or with land claims that are pending. Companies distributing and selling biocontrol products indicated that the lack of technical knowledge by sales personnel is one of the main problems experienced with marketing biocontrol products. Manufacturing companies also experienced difficulty with the registration of new products in South Africa.

Advancing Vertebrate Pest Control on a Global Scale

Author(s): Peacock, Anthony J. | Abstract: Vertebrate pest animal control and research is a relatively small area of activity within the agricultural and environmental fields. However, it is critical for agricultural productivity and biodiversity. There is much to be gained by having vertebrate pest controllers and researchers collaborating worldwide. The critical mass achieved through collaboration will result in faster registration of new products, better implementation of new methods, and increased skills within vertebrate pest units. The plain fact is that vertebrate pest control involves the killing of animals, sometimes those with iconic status. Having the public, or even other scientists, recognize the need for animal control can be complicated because of people’s natural concern for the welfare of animals. Those involved in the sector must become better advocates for the agricultural and biodiversity benefits of animal control. Although it is very uncomfortable for many scientists, they must face up to community dialogue in all its modern forms, and not simply rely on scientific reports and published papers speaking for themselves.

Report of the Commission on Intellectual Property Rights, Innovation and Public Health: a call to governments

The Commission on Intellectual Property, Innovation and Public Health (CIPIH) was given the task of reviewing existing research and development (R&D) efforts, examining the role of intellectual property (IP) in stimulating innovation, and to make concrete proposals for action by national and international stakeholders, both public and private, to encourage R&D for diseases that disproportionately affect developing The Commission focussed exclusively on the application of IP to pharmaceuticals, and did not address the public health implications of copyright law, or genomic patents, which are covered elsewhere in this issue. The report (1) presents a wealth of evidence and analysis in support of the view that the current system of drug development is fundamentally flawed and leaves huge health needs unmet, because of its reliance on patents and commercial incentives for the priority-setting and financing of medical R&D. The report calls for improved mechanisms that promote research that responds to patients' needs, and that ensure access to innovations for all. However, it fails to provide alternatives and concrete new proposals. Many of the data presented in the report illustrate the urgent need for change. I will discuss some of the Commissions more salient conclusions, on intellectual property rights, international trade, access to medicines, and global frameworks. Intellectual property rights The report recognizes that IP is a means and not an end. It concludes that IP is irrelevant in stimulating innovation in developing countries where markets have limited purchasing power, confirming the same finding by the UK Commission on Intellectual Property Rights in September 2002. (2) The report says: There is no evidence that the implementation of the TRIPS Agreement in developing countries will significantly boost R&D in pharmaceuticals on Type II and particularly Type III diseases. Insufficient market incentives are the decisive factor. (1) The report also points out that even in regions with strong IP protection, innovation results are declining. In the USA for example, medical R&D spending has doubled between 1995 and 2002, while in the same period, the registration of new products has declined, as well as the therapeutic significance of products reaching the market. In other words, although worldwide patent standards have been strengthened since 1995 as a result of the TRIPS Agreement, and global spending on medical R&D has increased, pharmaceutical innovation has declined both in quantity and quality. Furthermore, the report draws attention to the fact that patents can actually hamper innovation, by blocking follow-on research or access to research tools. The CIPIH identifies patent pools, compulsory licensing, and the application for research exemptions as potential solutions to overcome barriers caused by patenting. International trade and competition The report warns against trade agreements that include so-called measures. The Commission concludes: Bilateral trade agreements should not seek to incorporate TRIPS-plus protection in ways that may reduce access to medicines in developing countries. (Recommendation 4.21). (1) Data is one example of a TRIPS-plus provision often included in bilateral trade agreements with the US. The report offers much awaited clarity on issues related to the protection of data submitted by companies to obtain marketing approval for new medicines. WTO Members are obliged to protect undisclosed test or other data against unfair commercial use. But this does not imply property rights, nor a right to prevent others from using the data, or from relying on the data for the marketing approval of the same product by a third party--except where unfair, dishonest commercial practices are involved. Developing countries have been pressured during bilateral talks to accept TRIPS-plus provisions including data exclusivity rules that would delay the introduction of generic medicines. …

Canadian Access to Hormonal Contraceptive Drug Choices

On October 29, 2002, Health Canada issued Guidance for Industry: Clinical Development of Steroidal Contraceptives Used by Women. The original draft of this guideline, published July 4, 2001, included recommendations for clinical trials in excess of those required in Europe and the United States. The proposed requirements, which reflected Health Canada’s views, had the potential to discourage contraceptive research in Canada and to block registration of new products. To evaluate the impact of Canada’s hormonal contraceptive regulation, a comparative analysis of the availability of products in various countries was performed, along with an evaluation of the time required from submission to approval of a new drug. Women in Canada have access to 35% of the contraceptive products available worldwide and to 37% of the hormonal contraceptives available worldwide, compared with 58% and 59% respectively, in the United States; 52% and 54% respectively, in the United Kingdom; 44% and 54%, respectively, in France; and 44% and 50% respectively, in Sweden. Regarding the more recent contraceptive products available worldwide, women in Denmark have the most choices (67% of available products), whereas women in Canada have the least (only 22% of available products). Eleven of 12 oral contraceptive products recently approved in other countries have either not been submitted for approval in Canada or remain in the Canadian regulatory process. Although the time-to-approval period in Canada, for drugs in general, is 6 months longer than in the United States, the mean lag time for 6 contraceptive products is 29.6 months as of January 1, 2004, and no oral contraceptives have been approved in Canada since 1997.

Literature-based marketing applications for pharmaceuticals in Australia

The Therapeutic Goods Administration (TGA), Australia’s regulatory agency, has codified its approach to the use of bibliographic data to support applications for the registration of new products and for variations to the registration of existing products through the development of a ‘points to consider’ document. The guidelines recognize the limitations of literature searching and the information contained generally within published papers and set out specific requirements for compiling and presenting bibliographic data. The TGA’s requirements, based on the principles of performing systematic reviews of the literature, and their impact are reviewed.

The Environmental Protection Agency's Programs to Encourage the Use of Safer Pesticides

The Office of Pesticide Programs (OPP) within the United States Environmental Protection Agency (EPA) has initiated several programs to reduce risks associated with the use of pesticides. Examples include accelerated registration of new products (including biological pesticides) that offer reduced risk to human health and the environment, and regulatory relief for products posing virtually no risk to provide replacement for more problematic pesticides. In addition, efforts are being undertaken to reduce pesticide resistance in target pests, develop joint “Environmental Stewardship” efforts between the EPA, United States Department of Agriculture (USDA), and the United States Food and Drug Administration (FDA). The new Biopesticides and Pollution Prevention Division (BPPD), established as a pilot in October 1994, has responsibility for many above functions, with special emphasis on registration of biological pesticides and development of the new Pesticide Environmental Stewardship Program (PESP). This program is designed to recognize achievements already made by farmers to reduce conventional pesticide use and to find further improvements through cooperative efforts with growers.