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沙特 SFDA
    发布时间: 2021-03-22 11:01    

                                                                                                          沙特食品和药物管理局

         沙特食品和药物管理局(SFDA)是根据部长理事会日期为07/01/1424 H的第(1)号决议设立的,是一家直接向部长会议主席直接报告的独立法人公司。管理局的目标是确保人类和动物用食品和药品的安全,以及生化物质和电子产品的安全。

Depurty Premier殿下王储主持的董事会。其成员包括市政和农村事务高级专员,副主席,以及所有相关部长(人力资源部内政部长,卫生部长,工商部长,农业部长,水电部长,财政部长和部长)。经济和计划局)。沙特阿拉伯标准和规范组织总干事,沙特阿拉伯工商会理事会主席,管理局执行长以及专门从事食品和药品的人士。 

 管理局的主要目标

SFDA设立的主要目的是监管,监督和控制食品,药品,医疗器械,并制定强制性的标准规范,无论这些规范是进口的还是本地制造的。控制和/或测试活动可以在SFDA或其他机构的实验室中进行。此外,国家食品药品监督管理局负责消费者对与食品,药品和医疗器械以及所有其他产品和用品有关的所有事项的意识。 

SFDA的主要目标可概述如下:

  • 观察食品和药品对人类和动物的安全性,安全性和有效性。

  • 遵守补充性生物和化学物质,化妆品和杀虫剂的安全性。

  • 观察医疗设备的安全性及其对公共健康的影响。

  • 确保医疗和诊断设备的准确性和安全性。

  • 制定明确的食品和药品政策和程序,并计划实现和执行这些政策。

  • 进行研究和应用研究,以确定健康问题,其原因,确定其对公众的影响,并考虑研究/研究评估方法。当局应为食品和药品领域的宣传和咨询服务以及执行计划建立科学基础。这可以通过招募专家和专家,或者通过与阿卜杜勒阿齐兹国王科技城(KACST)和/或大学研究中心等研究机构的合作来实现。

  • 对食品,药品和医疗器械工厂的许可程序进行控制和监督。

  • 与本地和国际科学和法律机构进行传播和交换信息,并建立食品和药品数据库。

 管理局任务开始的阶段 

管理局将分两个阶段开始其分配的任务:第一个阶段将自其成立决议之日起为期五年,并被认为是第二阶段的准备和接受。

在第一阶段,它将承担以下任务:
  • 修改,制定和更新法规以应对质量要求和健康安全,并通过适用的法律渠道将其报告给相关各方进行审核和发布。

  • 王国批准了食品和药品政策,并制定了旨在确保食品和药品质量和安全的计划。

  • 设置特定的机制和实用手段,以帮助有关机构完成行政和现场跟进工作,以确保轻松,安全地执行法律法规。

  • 采用使食品和药品监管机构能够验证流通食品和药品成分中所含信息的准确性和有效性的方法和技术。

  • 设定指定的原则,以允许食品和药品监管现场工作人员在必要时进行迅速和直接的协调。

  • 发布药品和医疗器械生产,分销,进口和注册的规范,标准和特别规定。这将与卫生部和沙特阿拉伯标准和规范组织(SASCO)协调。

  • 与沙特阿拉伯标准和规格组织合作并协调,设置并认证与产品和商品的定标,校准,代码和标识有关的国家标准规范的文本,以及与食品和药品有关的任何物品的取样方法。国资委)。

  • 准备检测食品和药品的规格,程序和方法。

  • 发起并确定食品工业设施及相关工人应遵守的卫生规范和要求,并与工业和电力部以及商务部合作。

  • 与卫生部和其他政府机构合作,制定平台和一般政策以确保沙特阿拉伯有适当的药物供应,为沙特人民提供卫生服务。

  • 与市政和农村事务部合作并协调起草卫生要求,所有与公共卫生相关的网点都应提供卫生要求。

  • 与卫生部,财政部(海关)和商务部合作,制定规范通关药品检查的规则,标准和方法。

  • 提出与对违反食品和药品法的刑罚适用的法律规则,并从主管当事方处签发。

  • 推出控制和检查动物屠宰场所的规则,程序和要求,组织屠宰场,屠宰场和肉类销售场所。这将与市政和农村事务部进行协调与合作。

  • 管理局承诺建立培训和发展方案的方法,手段和计划,以确保提高有关部门工作人员的能力。并由这些部门承担实施和监督工作。

  • 与地方,区域和国际组织交换和传播信息(在其工作范围和职责范围内),并在需要信息时查找有关管理局作为参考组织的工作范围的数据库。另一方面,回答有关食品和药品的查询。

  • 进行研究和应用研究,以查明健康问题,其原因并确定其影响。这包括评估所采用的研究和研究方法,以及建立科学数据库以用于食品和药品领域的信息,教育,咨询服务和执行计划。这将通过专家与从事食品和毒品事务的组织以及科学中心合作,加入管理局。

在第二阶段,管理局将承担以下程序,监管和校准任务:
  • 对药物和药品进行必要的分析,以确定是否符合标准和规格。

  • 检查兽药是否需要通关。

  • 对儿童食品,治疗性饮用水,烟草和植物衍生物进行检查。

  • 分析与人类健康有关的项目,除了符合标准和规范外,还应强调其对人类使用的有效性。

  • 检查所有农产品和动物产品及货物是否通关。

  • 测试药物以进行通关。

  • 在食品和药品中适用打击商业欺诈的规定。

  • 测试兽药是否需要通关。

  • 确保动物产品有卫生条件,并提供检疫建议。

  • 分析化学和微生物食物和水的样品,提交发现结果,并根据发现结果建议治疗病例,并据此做出适当的决定。

  • 监督有关食品和药品的法规和法律的执行情况。

  • 监督对违反食品和药品法的处罚的适用。

  • 对生产食品和药品的植物或与人类消费有关的植物进行卫生监测。

  • 控制进口物品(食品和药品)。

  • 控制和检查市场,食品商业中心,饭店和食品工厂,以确保其遵守并遵守沙特的规范以及在食品和药品领域与商业欺诈作斗争的法律。

  • 监督食品工人,旅馆的安全并对其进行定期检查。

  • 根据农业和动物检疫法规控制动物和农业物品。

  • 根据质量和合格证书的条款,在生产过程中和生产过程之前控制本地加工的食品。

  • 对所有与公共卫生有关的商店进行监督,并遵守卫生要求。

  • 监视和检查动物屠宰场所,规范屠宰场,屠宰场和肉类销售场所。

  • SFDA网站:https://www.sfda.gov.sa/ar/overview

  • 联系人:Jacky cheng  13958111261( 同微信 ) Email:dowell001@cccdw.cn

                                                                                                     

                                                                                                                Saudi Food And Drug Authority

The Saudi Food and Drug Authority (SFDA) was established under the Council of Ministers resolution no (1) dated 07/01/1424 H, as an independent body corporate that directly reports to The President of Council of Ministers. The Authority objective is to ensure safety of food and drug for human and animal, and safety of biological and chemical substance as well as electronic products.

A Board of Directors, chaired by HRH Crown Prince, Depurty Premier. Its membership includes HRH Minster of Municipality and Rural Affairs as vice-chairman, and all pertinent ministers (HRH Minister of Interior, Minister of Health, Minister of Commerce and Industry, Minster of Agriculture, Minister of Water and Electricity, Minister of Finance and Minister of Economic and Planning). As well as, the Director General of Saudi Arabian Standards and Specification Organization, the Chairperson of Council of Chambers of Commerce and Industry in the Kingdom, the Authority's Executive Chief, and a person specialize in food and drug.

Authority's main objectives

The main purpose of the SFDA establishment is to regulate, oversee, and control food, drug, medical devices, as well as to set mandatory standard specifications thereof, whether they are imported or locally manufactured. The control and/or testing activities can be conducted in the SFDA or other agency's laboratories. Moreover, the SFDA is in charge of consumers awareness on all matters related to food, drug and medical devices and all other products and supplies.

The main objectives of SFDA can be outlined as follows:

  • Observe the safety, security, and effectiveness of food and drug for humans and animal.

  • Observe the safety of complementary biological and chemical substances, cosmetics and pesticides.

  • Observe the safety of medical devices and its impact on public health.

  • Ensure accuracy and safety of medical and diagnostic devices.

  • Launch clear policies and procedures for food and drug, and plan to achieve and implement these policies.

  • Conduct research and applied studies to identify health problems, their causes, determine its impact on public, with the consideration of methods for research / studies evaluation. The authority shall establish scientific bases for awareness and consulting services and executive programs in the fields of food and drug. This can be accomplished through the recruitment of experts and specialists or through the partnership with research bodies such as King Abdulaziz City for Science and Technology (KACST) and/or universities research centers.

  • Control and supervise licenses procedures for food, drugs and medical devices factories.

  • Disseminate and exchange information with local and international scientific and legal agencies, and setting up a database for food and drug.

Phases of Authority's tasks commencement

The Authority will commence its assigned tasks in two phases: the first one will last for a period of five years with effect from the date of the resolution of its establishment and considered preparative and inceptive for phase two.

In the first phase, it will assume the following tasks:
  • Revise, develop and update regulatory laws to cope with quality requirements and health safety, and report the same to concerned parties for review and issuance through applicable legal channels.

  • Ratification of Food and Drug policies in the Kingdom and set plans targeted to ensure quality and safety of food and drug.

  • Setting of specified mechanism and practical means to help the concerned agencies accomplish administrative and field follow up to ensure easy and safe application of laws and regulatory orders.

  • Adopt methods and techniques that enable Food and Drug regulatory agencies to verify accuracy and validity of information contained in the ingredients of circulated foodstuffs and drugs.

  • Setting specified principle to allow Food and Drug regulation field workers to make prompt and direct coordination whenever necessary.

  • Launch specifications, standards and special stipulations for production, distribution, importation and registration of drugs and medical devices. This will be in coordination with Ministry of Health and Saudi Arabian Standards and Specifications Organization (SASCO).

  • Set and certify texts of National Standard Specifications related to scaling, calibration, codes and identification of products and goods, in addition to methods of sample taking for any item related to food and drug, in collaboration and coordination with Saudi Arabian Standards and Specifications Organization (SASCO).

  • Prepare specifications, procedures and methods of detecting food and drug products.

  • Launch and pinpoint hygienic specifications and requirements that food industries facilities and related workers therein shall abide by, in accord and cooperation with Ministry of Industry and Electricity, and Ministry of Commerce.

  • Draw platforms and general policies that ensure availability of appropriate drug in the kingdom, in cooperation with Ministry of Health and other governmental agencies provide health services for the Saudi people.

  • Draw up hygienic requirements that are to be available in all outlets linked with public health, in collaboration and harmony with Ministry of Municipality and Rural Affairs.

  • Draw rules, standards and methods that regulate drugs examination for customs clearance, in cooperation with Ministry of Health, Ministry of Finance (Customs Department) and Ministry of Commerce.

  • Propose legal rules relative to application of penalties on violators of food and drugs laws, and get them issued from the competent party.

  • Launch rules, procedures and requirements for control and inspection of animals' slaughtering places, organize slaughterhouses, butcheries and meat sale outlets. This will be in coordination and collaboration with Ministry of Municipality and Rural Affairs.

  • The Authority undertakes to set up methods, means and plans for training and developmental programs that ensure promote competency of staff in pertinent departments. It shall also assume their implementation and supervision with these departments

  • Exchange and disseminate information, (within its scope of work and responsibilities), with local, regional and international organizations, and to find a database on Authority's scope of work as a reference organization when information is required. On the other hand, answers queries on food and drugs.

  • Conduct researches and applied studies to pinpoint health problems, their causes and identify their effects. This includes assessment of adopted methods for researches and studies, and building of scientific database to be availed for informative, educational, advisory services and executive programs in food and drug arena. This will be through specialists to join the Authority in collaboration with organizations engaged in food and drug affairs and scientific centers.

In the second phase, the Authority will assume the following procedural, regulatory and calibration tasks :
  • Conduct necessary analysis on drugs and pharmaceutical to determine thier conformity to standards and specifications.

  • Check veterinary drugs for custom clearance.

  • Conduct check up for children food, therapeutic potable water, tobacco and plant derivatives.

  • Analyze items linked to human health to emphasize their validity for human usage in addition to their compliance with standards and specifications.

  • Inspect all agricultural and animal products and goods for customs clearance.

  • Test drugs for customs clearance.

  • Apply provisions of commercial fraud fighting in food and drugs.

  • Test veterinary medicine for custom clearance.

  • Ensure availability of hygienic conditions for animal products and provide advice on quarantine.

  • Analyze chemically and microbial food and water samples, submit findings, and advice for treatment of cases according to findings, and take appropriate decisions accordingly.

  • Supervise implementation of statues and laws related to food and drug.

  • Supervise application of penalties on violators of food and drug laws.

  • Hygienic monitoring on plants producing foodstuff and drug or those related to human consumption.

  • Control imported items (food and drug).

  • Control and inspect markets, foodstuff commercial centers, restaurants, and food plants to ensure their abidance by and adherence to Saudi specifications, as well as laws of commercial fraud fighting in field of food and drug.

  • Supervise safety of food workers, hotels and make periodical examination thereon.

  • Control animal and agricultural items under agriculture and animal quarantine statues.

  • Control locally processed food items before and during production process, under the terms of quality and compliance certificate.

  • Supervise all outlets relative to public health and observe to meet hygiene requirements.

  • Monitor and inspect animal slaughtering places, regulate slaughterhouses, butcheries and meat sale outlets.

  • https://www.sfda.gov.sa/ar/overview

  • 联系人:Jacky cheng  13958111261( 同微信 ) Email:dowell001@cccdw.cn

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