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The Study Programme for the Quality Management of Essential Medicines - Good Manufacturing Practical (GMP) and Inspection

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The Study Programme for the Quality Management of Essential Medicines - Good Manufacturing Practical (GMP) and Inspection The Study Programme for the Quality Management of Essential Medicines - Good Manufacturing Practical (GMP) and Inspection - Country Reports Japan International Corporation of Welfare Services (JICWELS) Contents 1. Cambodia 1 2. Indonesia 70 3. Malaysia 91 4. Philippines 116 5. Sri Lanka 141 6. Thailand 161 The Study Programme for the Quality Management of Essential Medicines - Good Manufacturing Practical (GMP) and Inspection - Cambodia -1- KINGDOM OF CAMBODIA Nation Religion King Ministry of Health Department of Drugs and Food Country Report The Study Program on Quality Management of Essential Medicines Good Manufacturing Practice (GMP) and Inspection November 4, 2012 – November 30, 2012 Sponsored by : The Government of Japan Japan International Cooperation Agency (JICA) Department of Drugs and Food Ministry of Health, Cambodia. -2- I- COUNTRY PROFILE -3- A-Geography Cambodia is an agricultural country located in South East Asia which bordering the Gulf of Thailand, between Thailand, Vietnam, and Laos. Its approximate geographical coordinates are 13°N 105°E. Its 2,572 km border is split among Vietnam (1,228 km), Thailand (803 km) and Laos (541 km), as well as 443 km of coastline. Cambodia covers 181,035 square kilometers in the southwestern part of the Indochina, Cambodia lies completely within the tropics; its southernmost points are only slightly more than 10° above the equator. The country is bounded on the north by Thailand and by Laos, on the east and southeast by Vietnam, and on the west by the Gulf of Thailand and by Thailand. It consists of the Tonle Sap Basin and the Mekong Lowlands. To the southeast of this great basin is the Mekong Delta, which extends through Vietnam to the South China Sea. Cambodia's climate, like that of the rest of Southeast Asia is dominated by monsoons, which are known as tropical wet and dry because of the distinctly marked seasonal differences. The temperatures are fairly uniform throughout the TONLE SAP Basin area, with only small variations from the average annual mean of around 25 °C (77.0 °F). The maximum mean is about 28.0 °C (82.4 °F); the minimum mean, about 22.98 °C (73.36 °F), Cambodia is influenced by Monsoon. Every year, the Monsoon winds blow from the North-East bringing cold weather with some rain from November to March and from May to October, the Monsoon blow from South-West bringing along with lots of rains and humid weather that January is the coolest month and April is the warmest. Cambodia’s populations in 90% are Khmer and the rest are other minority such as Cham, Vietnamese, Chinese and group of tribe people like PHNONG, STING and KOUY who live with a belief of -4- Mountain People. The population of Cambodia was census in 2011 recorded a total of 14.7 million, with a population growth rate of 1.7% per annum (WB data 2011). The proportion of population living in rural areas is 80.5%; only 19.5 % of country’s residents live in urban areas. The population density in the country as a whole is 75 per square kilometer, with approximately 1.3 million inhabitants living in Phnom Penh. Since the 1991 Paris Peace Accord, Cambodia’s economy has made significant progress after more than two decades of political unrest. However, Cambodia still remains one of the poorest and least developed country in Asia, with the gross domestic product per capita estimate at approximately 3.3 million Riel or $805 in 2010 (International Monetary Fund,2011). Agriculture, mainly rice production, is still the main economic activity in Cambodia. Small scale subsistence agriculture, such as fisheries, forestry, and livestock, and is another important sector. Garment factories and tourism services are also important components of foreign direct investments. B- LANGUAGE: Khmer or Cambodian, is the language of Khmer people and the official language of Cambodia, however the people are free of use their mother tongue and other language. Khmer has been considerably influenced by Sanskrit and Pali, especially in the royal and religious registers, through the vehicles of Hinduism and Buddhism. In old generation, for secondary language is French but after election in 1993 the Government has adopted the free market policy, we are to use other languages without limited refer to working places/offices, many investors have came to Cambodia for their business and also Non-Government Organizations have started their activities in Cambodia. Thus English, -5- Chinese, French, Japanese and Korean are widely spoken, especially in business field and in government offices. Cambodians from different regions of country speak variant accents, but it is understood by all people throughout the country. C- CULTURE: Cambodia culture has had a rich and varied history dating back many centuries, and has been heavily influenced by India and China. However, Cambodian have still kept the own culture for long time such as Khmer weeding, Khmer New Year in April, PHUM BEN, Water festival, etc. The Ministry of Culture has concentrated on culture and Khmer custom and tradition. 90% of Cambodian people have abided by tradition and customs. KHMER WEDDING PHUM BEN WATER FESTIVAL APSARA DANCING -6- D-RELIGION: Cambodia is predominantly Buddhist with 90% of the population being Theravada Buddhist, 1% Christian and the majority of the remaining population follows Islam, atheism, or animism, but in Highland tribal groups, most with their own local religious systems, probably number fewer than 100,000 persons. The Khmer LOEU has been loosely described as animists, but most tribal groups have their own pantheon of local spirits. However, in our national constitution is decided to Buddhist is the religion of state. E-EDUCATION SYSTEM: Education in Cambodia was traditionally offered by Pagodas (Buddhist temples), thus providing education exclusively for the male population. The formal educational structure consists of six years of primary school (grades 1–6), three years of lower secondary school (grades 7–9), and three years of upper secondary school (grades 10–12). The Education field is very mains to create the human resources, develop the National country and educate people all the rank. The Government pays attention to the human resources and it is always enhanced by Government. -7- There are Education in System and Education out System - Education in system means that Education in the state school. - Education out system means that Education follows organization and private school. Education in Cambodia divided into 3 kinds 1- State School 2- Private School 3- Organization School Cambodia has 7 phases Education 1- Kindergarten 2- Elementary School 3- Secondary School 4- High School 5- Faculty / University 6- Master Degree 7- .Doctor Degree -8- II- STATISTICAL DATA -9- -10- Department Drugs and Food reported, September 2012 a- Number of pharmaceutical manufacturers are nine sites: 1-Chea Chamnan 2-Medical supply 3-EUPHAC 4-PPM 5-CPE 6-Bio- Meta 7-GEN PHARMA 8-BRIGHT FUTURE 9-LLCO b- Number of pharmaceutical Importers are 116 sites c- Number of pharmaceutical Whosalers are 1601 sites -11- III- HISTORICAL DEVELOPMENT of PHARMACEUTICAL SERVICE A-History of the National plan on Pharmaceutical Services: The First National Drug Policy published in 1995, then reviewed and endorsed in 1998, and last update in 2010 by the Minister of health assisted by World Health Organization in Phnom Penh, as the guidelines of the development about: -Legislation and Regulations of Drugs -Selection of Pharmaceutical products -Drugs supply system -Drugs distribution and Good storage Practices -Drugs quality control system -Financing of drugs and Pricing Policy -Rational drugs use -Traditional Medicines -Monitoring and Evaluation (which will enable progress and adjustment of Strategies) The main mission of Department of Drugs and Food in 2012 To control and eliminate illegal drug outlets in whole country To serch the source of counterfeit and substandard medicines to eliminate. -12- To assure that manage all medicines at public health services. To Educate guidance and use all nacotic medicine upon to technical To publish all counterfeit medicine and issue of counterfeit medicine To monotoring and evaluate the usage of medicines at public health services To strenghtening register system as the same as regional country. To educate and guidance focus on law that related to food hygien and safety to restaurant owner. B-History of GMP Ministry of Health decided to follow of WHO GMP, and step by step harmonize with regional Asian GM P. Now Cambodia GMP follows ASEAN GMP guidelines, but we had gradually modified according to our current situation and through experience from training courses provided by international partners such as WHO, especially JICA, JICWELS... In 1999, the ministry of health advised the local pharmaceutical manufacturers to implement the principles of GMP as in Prarkas (Decision) number 513 issued in December 1999, the meaning of GMP is base on the WHO GMP and Japan GMP and flexible of Asian GMP, such as focus on the definition, personnel, premises, equipment, sanitation and hygiene, production, quality control, self inspection, recall product and documentation, etc, Since then, the department of drugs and food, MoH and WHO started to develop the guideline and conduct training to key persons of local manufacturers and pharmacist responsible and -13- quality control staffs to get the knowledge of GMP, and some workshops of dissemination were prepared that corporate with the manufacturers association and WHO expertise, In 2006, under support of WHO,
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