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  1. 1

    Making pregnancy safer: the critical role of the skilled attendant. A joint statement by WHO, ICM and FIGO.

    World Health Organization [WHO]; International Confederation of Midwives; International Federation of Gynecology and Obstetrics [FIGO]

    Geneva, Switzerland, WHO, Department of Reproductive Health and Research, 2004. [23] p.

    In 2000, the largest-ever gathering of heads of state at the United Nations in New York, USA, adopted the UN Millennium Declaration. This historic compact among nations includes eight critical goals—the Millennium Development Goals (MDGs)—for combating poverty and accelerating human development. Two of the eight MDGs relate to reducing child mortality and improving maternal health, respectively, pointing to the importance of these health factors in global development and poverty reduction. The World Health Organization (WHO), the International Confederation of Midwives (ICM) and the International Federation of Gynecology and Obstetrics (FIGO) are pleased to see the inclusion in the MDGs of the target to reduce by three-quarters, between 1990 and 2015, the maternal mortality ratio. This inclusion is the result of many years of advocacy (by WHO, ICM and FIGO, among others) for the need to recognize the link between maternal health and development. The MDGs send yet another reminder to planners and policy-makers that for the world’s poor motherhood still carries a high risk of morbidity and mortality. But years of previous work in making motherhood safer has not all been in vain. There is now a global consensus on what must be done to eliminate the menace of maternal deaths once and for all. Already in 1999, a joint WHO/UNFPA/ UNICEF/World Bank statement called on countries to “ensure that all women and newborns have skilled care during pregnancy, childbirth and the immediate postnatal period”. (excerpt)
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  2. 2

    WHO Expert Committee on Specifications for Pharmaceutical Preparations. Thirty-second report.

    World Health Organization [WHO]. Expert Committee on Specifications for Pharmaceutical Preparations


    The WHO Expert Committee on Specifications for Pharmaceutical Preparations reports that several national and regional drug regulatory authorities have adopted guidelines for good manufacturing practices for drugs similar to those recommended by the Committee. Annex 1 discusses these practices and makes up most of the Committee's 32nd report. The report also presents provisional guidelines on inspection of pharmaceutical manufacturers. It reviews the WHO Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce. The Committee-endorsed scheme depends on a more effective exchange of information to more rigorously control all international trade of pharmaceuticals. Chapter 6 looks at the international pharmacopoeia and related activities, including quality specifications for drug substances and dosage forms, validation of analytical procedures, a simple test methodology, national laboratories for drug surveillance and control, and quality control of products derived from medicinal plants. The report discusses and lists the International Chemical Reference Substances and International Infrared Reference Spectra. it also addresses stability of dosage forms and extemporaneous preparations. Annex 4 presents guidelines to guarantee the quality of pharmaceutical and biological drugs prepared by recombinant DNA technology. Another annex looks at validation of analytical procedures used to examine pharmaceutical materials. The last annex discusses the protocol for a proposed study on the quality of some drugs at the point of use in developing countries. WHO has already asked Benin, Guinea, Mozambique, Uganda, and Tanzania in Africa, Bangladesh and Myanmar in Asia, and Guatemala and Peru in the Americas to participate.
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  3. 3

    [An analysis of the regulation processes governing contraceptive methods in Bolivia. Final report. The Population Council / Bolivia in-house project, October 1993 - February 1994] Analisis del proceso regulatorio para metodos anticonceptivos en Bolivia.

    De la Quintana C

    [Unpublished] 1994 Feb. [11], 60, [9] p. (USAID Contract No. DPE-3030-Z-00-9019-00)

    This report provides a comprehensive analysis of Bolivian regulations governing family planning methods and the impact of these regulations on the pharmaceutical industry and marketing of contraband contraceptives. The study sought to 1) synthesize existing regulations and norms; 2) examine the gap between these regulations and norms and the actual behavior of providers, importers, and donor agencies; and 3) document all aspects of the regulatory process. The first three chapters of the report provide a general overview of the regulations covering usage, importation, commercialization, and distribution of contraceptives in Bolivia. Chapter 4 compares these regulations with actual practice and points out the consequences of the disparity, and the fifth chapter analyzes the effect of the existing legal framework on service providers, importers, and international agencies and looks at the impact of a weak regulatory system on compliance. The overall finding is that lack of familiarity with the wide range of laws, norms, and commercial requirements governing contraceptives has led to widespread misconceptions about the legal status of various methods and to general disregard of the regulations. Specific findings are that 1) many providers mistakenly believe that no contraceptive methods are legally registered, 2) the regulations governing the commercial importation of contraceptives differ from those governing the importation of methods by international agencies, 3) the registration process that allows commercial importation is cumbersome and lengthy and characterized by a lack of data and access to information, and 4) compliance with the regulatory processes and norms governing importation and commercialization increases the original import price of each pharmaceutical product by 50% and, thus, reinforces the illegal importation of contraband products.
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  4. 4
    Peer Reviewed

    Regulatory actions to enhance appropriate drug use: the case of antidiarrhoeal drugs.

    Haak H; Claeson ME

    Social Science and Medicine. 1996 Apr; 42(7):1011-9.

    Inappropriate drug use is a major problem in the control of diarrheal diseases. Addressing the problem, the World Health Organization's (WHO) Program for the Control of Diarrheal Diseases reviewed the literature on the most commonly used antidiarrheal agents, and distributed the resulting document widely in 1990. Individual and group campaigns against the registration and use of antidiarrheal drugs also brought considerable attention to the issue in the popular media. This article evaluates the actions taken against antidiarrheal drugs by national drug regulators during and after these events, January 1989 through December 1993. Information on regulatory actions was requested from countries and extracted from published and unpublished sources. 16 countries reported regulatory actions on 21 occasions during the period of study, with the majority of actions taken against antimotility drugs. Few were against adsorbents, antidiarrheal drugs containing antimicrobials, or adult formulae. Six countries took action against large and heterogenous groups of antidiarrheal drugs, with most actions occurring within two years of the distribution of the WHO review and the attention in the media. Many more antidiarrheal drugs may lose their register in the future through a passive deregistration process. The deregistration of inappropriate drugs, however, will probably take quite a while, with widespread deregistrations unlikely. Moreover, regulatory actions alone are probably not enough to achieve a more appropriate use of drugs. Greater effect can be expected from simultaneous regulatory, managerial, and educational interventions directed at providers, combined with communication to the general public.
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  5. 5

    IUDS for India were safe [letter]

    Bronnenkant LJ


    In reply to a summary of an article by Bhupesh Mangla (Lancet, May 29, 1993), a representative of Finishing Enterprises, Inc, the original licensee of the Population Council for manufacture of the Copper T IUD, maintains that the components supplied to Hindustan Latex Ltd (HLL), the Indian company selected in a program of the Indian government and the UN Population Fund (UNFPA) to manufacture the finished IUDs, were neither defective nor substandard. The National Centre of Technical Evaluation of the Indian Institute of Technology, which had no previous experience in this area, established its own specifications prior to transfer of the technology. Finishing Enterprises was uninformed of the changes and delivered components made according to US Food and Drug Administration and international standards. Since they did not meet the Indian specifications, it was recommended that they be held. This does not mean they were unsafe. Differences in the standards were discussed in March 1992 by experts during a Population Council meeting organized by the Indian government and UNFPA. The components were certified to meet international standards and were found to be safe and suitable. The statement that the Ministry was pressured to accept the consignment without further action is, therefore, inaccurate. The Indian Ministry of Health and HLL have since resolved the issue, and manufacture of the IUDs is proceeding with the components supplied by Finishing Enterprises. This resolution was complicated by political motivation, personal bias, and pressure brought by competing Indian firms. In order to prevent this in the future, manufacturers who are experienced with international standards should be involved in evolving national standards, and care should be taken that these are communicated to the appropriate parties.
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  6. 6

    The use of essential drugs. Model list of essential drugs (seventh list). Fifth report of the WHO Expert Committee.

    World Health Organization [WHO]. Expert Committee on the Use of Essential Drugs


    The WHO Expert Committee on the USe of Essential Drugs has published its fifth report which has an updated list of essential drugs including route of administration and dosage forms and strengths. Names and affiliated organizations of Committee members and delegates of other groups as well as appropriate staff at the WHO Secretariat precede the report. Each member country can use this list to determine its own list based on its own policy and priorities. To help member countries, the Committee provides criteria for selecting essential drugs. The report also includes guidelines to establish a national program for essential drugs and guidelines for a national drug authority (Annex 1). A successful program depends on efficient administration of supply, storage, and distribution of drugs at every point from manufacturer to end user. The report also addresses quality control, the need to have reserve antimicrobials and to monitor resistance, and applications of the essential drugs concept. One chapter examines essential drugs and primary health care by focusing on existing systems of medicine, the national health infrastructure, training and supplies, and the pattern of endemic disease. The report provides guidance on drugs used in displaced communities by looking at nutrition, immunization, protection from infectious diseases, drugs, and surveillance. It also addresses postregistration drug studies and research and development. The final chapters cover nomenclature, drug information and educational activities, updating lists of essential drugs, considerations and changes made in revising the list, glossary, and alphabetical list of essential drugs. Annex 2 is an application form for inclusion in the Model List of Essential Drugs.
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  7. 7

    Quality assurance of vaccines.

    Sizaret P; Magrath DI

    In: Vaccines for fertility regulation: the assessment of their safety and efficacy. Proceedings of a Symposium on Assessing the Safety and Efficacy of Vaccines to Regulate Fertility, convened by the WHO Special Programme of Research, Development and Research Training in Human Reproduction, Geneva, June 1989, edited by G.L. Ada, P.D. Griffin. Cambridge, England, Cambridge University Press, 1991. 173-84. (Scientific Basis of Fertility Regulation)

    Biologicals specialists at WHO review quality assurance of vaccines at the national level for participants in a symposium on vaccines to regulate fertility. National control authorities (NCA) authorize a company to manufacture biological products only after it convinces the NCA that it will comply with good manufacturing practices (GMP) and WHO requirements for manufacturing establishments and control laboratories. Experts periodically inspect the facilities to assure that the company abides by GMP, WHO, and national regulations. NCA makes a decision to permit product use after successful evaluation for a set period of time (licensing). The manufacture must renew its license. Licensing involves a review of manufacturer's data on production methods and laboratory tests. The manufacturer does not need to conduct some tests for each production lot including data on characterization of banks of seeds (cells, bacteria, and viruses), details on production methods, and principal harmlessness of the product. The NCA also reviews test data from each production batch at the bulk level, at the final bulk and/or at the final product level, and at the final product level. Bulk level tests may include tests for neurovirulence and for the absence of virulent mycobacteria. Purity tests are carried out at the final bulk and/or at the final product level. Tests for potencies of live vaccines, the absence of contamination, and adjuvant content are final product level tests. Results of clinical studies on the safety and efficacy of the product also accompanies requests for licensing. After granting a license, the NCA must define release modalities (free release, partial free release, or release after the NCA has issued a release certificate). It must also operate a postmarketing surveillance system to prevent the unexpected from happening.
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