Document No. : FDA/SMC/SMD/GL-SMP/2015/05 |
These guidelines are for information, guidance and strict compliance by Marketing Authorization Holders and Local Representatives of regulated products to help in the continuous safety monitoring of products granted marketing authorization in Ghana.
Maldives has made significant strides in the area of infectious disease prevention and control. This is exemplified by elimination of malaria from Maldives in 2015 and successes in TB control. In addition, Maldives is a front runner in infectious disease prevention through successful water, sanitati...on, hygiene and vaccination campaigns and coverage. However, given the limited evidence that exists with respect to the occurrence of resistant organisms in the nation, it is hard to estimate the exact antimicrobial resistance (AMR) scenario. Also, it becomes difficult to compare the current situation with other countries in the region. Moreover, limited evidence exists on the trends of use of antimicrobial agents (AMA) in Maldives. Although, recent prescription audits have indicated overuse of antibiotics, especially for common conditions such as flu, cough and fever.
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EMCDDA Insights - 11
Accessed: 14.03.2019
Good Manufacturing Practice (GMP) describes a set of principles and procedures that, when followed, ensure that medicines and related substances are of high quality, safety and efficacy. SAHPRA is a
participating authority of the Pharmaceutical Inspection Cooperation Scheme (jointly known as PIC/S).... PIC/S aims to develop international standards between countries and pharmaceutical inspection
authorities, to provide harmonised and constructive co-operation in the field of GMP. PIC/S affiliation is subject to initial and periodic assessment of the participating authority to ensure that it has equivalent legislation, regulatory and enforcement procedures and inspection capacity.
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An Act to repeal the Dangerous Medicines Act of 1973,to ensure the availability of certain drugs for exclusive medical, scientific and related purposes, while preventing their abuse; to prevent the diversion from lawful trade of controlled chemicals, controlled equipment and controlled materials for... use in the unlawful manufacture of such drugs; to render drug trafficking and related conduct as serious criminal offences and to ensure that trafficking and related conducted as serious criminal offences and to ensure that offenders or suspects are brought to justice; to render certain conduct by drug users as criminal offences, to provide for the treatment and rehabilitation of drug abusing or dependent offenders; to establish the Lesotho Narcotics Bureau; and for related matters.
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Review over the work and challenges of the Nigerian National Agency for Food and Drug Administration and Control (NAFDAC) in combatting counterfeiting of medicines in Nigeria.
Comprehensive Reviews in Food Science and Food Safety, Vol.12 (2013) pp.234-248
In 2006, the Institute of Food Technologists (IFT) published an Expert Report entitled “Antimicrobial Resistance: Implications for the Food System” (IFT 2006). That report summarized current scientific knowledge pe...rtaining to the public-health impact of antimicrobial use in the food system and the development and control of antimicrobial resistance. Since that time, intense interest in this topic has continued within the regulatory and scientific communities as well as the general public. This IFT Scientific Status Summary serves to update that 2006 IFT Expert Report by briefly reviewing new scientific evidence relevant to the goals of the initial report and providing a number of key observations and conclusions.
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Antimicrobial resistance is one of the most important threats to the health worldwide. Antimicrobial resistance or drug resistance is the reduction of the pharmaceutical effects of a drug against a disease or reduction of its effectiveness in improving the clinical signs of a disease. Antimicrobial ...resistance occurs naturally but misuse of antibiotics in human and animals significantly accelerates the process of developing antimicrobial resistance. In fact, antimicrobial resistance refers to the resistance of a microorganism to one or more antimicrobial drugs which had been previously sensitive to these drugs. Antimicrobial resistance can occur in a wide variety of pathogens including bacteria, parasites, viruses, fungi, and cancer cells and may threaten the life of every person, in every age, and in every country
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The primary role of Benin’s Department of Pharmacy and Medicines (DPMED) is to develop and apply the national pharmaceutical policy. The main objective of this policy is to ensure the availability and accessibility of quality medicines for the population. To fulfill its mandate, DPMED aims to stre...ngthen its regulatory capacity, including the issuance of licenses to pharmaceutical establishments and the registration of pharmaceutical products. Benin’s current registration system shares core concerns that are common to most developing countries, notably the capacity to evaluate and monitor the security, efficacy, and quality of medicines and other health products. It is currently characterized by 1) poor or inadequate traceability of records or regulations (example: a product’s marketing authorization [MA] is often hard to find); 2) lack of evidence used in the regulatory decision-making process (reasons behind special import authorization, i.e., products without valid MAs); 3) inconsistent and unsecured archiving system; 4) limited human resources; and 5) an inefficient information management system
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The Operational guide: use of referral laboratories for the analysis of foodborne hazards in the Pacific aims to strengthen the food analysis capacity of Pacific Island countries and areas by identifying national and reference laboratories capable of testing for priority foodborne hazards. The Pacif...ic Island countries and areas are often vulnerable to food safety incidents and emergencies due to their geographical distribution and dependence on food imports. The guide outlines key considerations for selecting referral laboratories and submitting samples to them, enabling continuous improvement of food safety systems and providing safe food for all. The target audiences are health and food safety authorities.
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Antimicrobial resistance has become a serious public health threat for effective treatment of an ever increasing range of infections caused by bacteria, parasites, viruses and fungi. When infections can no longer be treated by first-line antibiotics, other antibiotics must be used, which are both mo...re expensive and more toxic. Treatment and hospitalization is prolonged, and patients undergoing operations and other medical procedures are more vulnerable to infections. All this imposes a huge burden on health care systems and on the economy of countries. This is a major challenge to the health system in Mauritius which provides health care free of user cost to the whole population.
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Medicinal plants occupied an important position in the socio-cultural, spiritual and medicinal arena of rural people of India. T
The present report is based on contribution made by members of the task force and many other experts on medicinal plants. We hope the report on implementation will promot...e sustainable and equitable development of medicinal plants sector provide "Health for All", boost exports, and will improve livelihood of the people and green the country for the present and the
generation to come.
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The main objectives of these guidelines are to:
1. contribute to the quality assurance of medicinal plant materials used as the source for herbal medicines to improve the quality, safety and efficacy of finished herbal products;
2. guide the formulation of national and/or regional GACP guideli...nes and GACP monographs for medicinal plants and related standard operating procedures; and
3. encourage and support the sustainable cultivation and collection of medicinal plants of good quality in ways that respect and support the conservation of medicinal plants and the environment in general.
These guidelines concern the cultivation and collection of medicinal plants and include certain post-harvest operations.
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Drugs and medical supplies are dispensed at the cutting edge level of the interface between the public health system and the people. Availability or lack of it brings either credit or discredit to the public health system. The primary reason for holding stocks of medicines and medical supplies in a ...proper scientific manner is to ensure continuous and uninterrupted availability to prevent stock-outs, especially of critical items of supply while at the same time ensuring that stocks of medicines do not get expired. An efficient inventory management is a pre-requisite for optimal stock management. It enables the management of health facilities to know the current pattern of consumption of drug trends over a period of time and also variances. The environmental control of the drugs and other medical supplies play an important role to keep the products' efficacy intact. Some medicines and vaccines need special storage temperature, otherwise, there may be wastage. The quality of the medicines can be adversely affected by poor storage, transportation and distribution. Thus, maintaining proper storage condition for health commodities is vital for ensuring their quality. So, by this training, CDMU wants to educate different people dealing with medicines and equip them for the roles they have to perform efficiently so that the wastage does not take place or can be minimized.
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Medical devices are used for the prevention, diagnosis and treatment of illness and diseases and for rehabilitation. WHO developed guidance on medical device donation in 2011, which has been now reviewed, with new evidence, new references on considerations for medical device solicitation and provisi...on, risks associated with inappropriate donations, the responsibilities of donors and recipient, and the steps they should follow before, during and after a donation. It includes three sections: description of major problems that may be faced during the donation process, listing of best practices for donors and recipients and addressing situations requiring special attention. It also has three annexes for further reading: the criteria for the acceptability of a donation, literature review on donations of medical devices between 2010 and 2023 and a flyer. This document is intended to improve the quality of medical devices donations, including medical equipment, single-use medical devices and in-vitro diagnostics, to provide maximum benefit to all stakeholders. The considerations can be used to develop institutional or national policies and regulations for medical devices donations. This document is intended for use by any organization, expert or practitioner involved in the donation, procurement, management of medical devices, including health workers, biomedical engineers, health managers, policymakers, donors, nongovernmental organizations and academic institutions.
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The larval stage of the parasite Taenia solium can encyst in the central nervous system causing neurocysticercosis, which is the main cause of acquired epilepsy in the countries in which the parasite is endemic. Endemic areas are those with the presence (or likely presence) of the full life cycle of... Taenia solium. The parasite is most prevalent in poor and vulnerable communities in which pigs roam free, open defecation is practiced, basic sanitation is deficient, and health education is absent or limited. Several tools are available for the control of Taenia solium. Preventive chemotherapy for Taenia solium taeniasis, which is directed at the adult tapeworm, is one of them. Other tools focus on pig management, pig vaccination and treatment, sanitation and hygiene, and community education. Three potential drugs—niclosamide, praziquantel, and albendazole—have been considered for use for preventive chemotherapy in Taenia solium taeniasis control programs through mass drug administration or targeted chemotherapy. In this Guideline, we provide recommendations for preventive chemotherapy in Taenia solium-endemic areas using niclosamide, praziquantel, or albendazole, including at which dose and in which population groups.
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