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Certificate Of Pharmaceutical Product
The certificate of pharmaceutical product (abbreviated: CPP) is a certificate issued in the format recommended by the World Health Organization (WHO), which establishes the status of the pharmaceutical product and of the applicant for this certificate in the exporting country; it is often mentioned in conjunction with the electronic Common Technical Document (eCTD). A CPP is issued for a single product, because manufacturing arrangements and approved information for different pharmaceutical forms and strengths can vary. The CPP is mentioned in World Trade Organization documents, although the tightly regulated products are subject to bilateral trade agreements or regional trade agreements. The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) has instituted standards for this purpose but it is unclear how the ex-ICH countries operate their health regulators. Scope The Certificate of a Pharmaceutical Product is needed by the im ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
World Health Organization
The World Health Organization (WHO) is a specialized agency of the United Nations responsible for international public health. The WHO Constitution states its main objective as "the attainment by all peoples of the highest possible level of health". Headquartered in Geneva, Switzerland, it has six regional offices and 150 field offices worldwide. The WHO was established on 7 April 1948. The first meeting of the World Health Assembly (WHA), the agency's governing body, took place on 24 July of that year. The WHO incorporated the assets, personnel, and duties of the League of Nations' Health Organization and the , including the International Classification of Diseases (ICD). Its work began in earnest in 1951 after a significant infusion of financial and technical resources. The WHO's mandate seeks and includes: working worldwide to promote health, keeping the world safe, and serve the vulnerable. It advocates that a billion more people should have: universal health care coverag ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Electronic Common Technical Document
The electronic common technical document (eCTD) is an interface and international specification for the pharmaceutical industry to agency transfer of regulatory information. The specification is based on the Common Technical Document (CTD) format and was developed by the International Council for Harmonisation (ICH) Multidisciplinary Group 2 Expert Working Group (ICH M2 EWG). History Version 2.0 of eCTD – an upgrade over the original CTD – was finalized on February 12, 2002, and version 3.0 was finalized on October 8 of the same year. , the most current version is 3.2.2, released on July 16, 2008. A Draft Implementation Guide for version 4.0 of eCTD was released in August 2012. However, work stalled on the project. An additional Draft Implementation Guide was released in February 2015 Draft specifications and guides were issued in April 2016 by the ICH and the FDA, followed by a May 13 ICH "teleconference to discuss the guidance and any questions and clarifications needed." U ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
World Trade Organization
The World Trade Organization (WTO) is an intergovernmental organization that regulates and facilitates international trade. With effective cooperation in the United Nations System, governments use the organization to establish, revise, and enforce the rules that govern international trade. It officially commenced operations on 1 January 1995, pursuant to the 1994 Marrakesh Agreement, thus replacing the General Agreement on Tariffs and Trade (GATT) that had been established in 1948. The WTO is the world's largest international economic organization, with 164 member states representing over 98% of global trade and global GDP. The WTO facilitates trade in goods, services and intellectual property among participating countries by providing a framework for negotiating trade agreements, which usually aim to reduce or eliminate tariffs, quotas, and other restrictions; these agreements are signed by representatives of member governmentsUnderstanding the WTO' Handbook at WTO officia ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Bilateral Trade Agreements
This is list of free-trade agreements between two sides, where each side could be a country (or other customs territory), a trade bloc or an informal group of countries. Note: Every customs union, common market, economic union, customs and monetary union and economic and monetary union is also a free-trade area. For fully multilateral agreements (not included below) see: List of multilateral free-trade agreements. For a general explanation, see free-trade area. Operating agreements List of agreements between two states, two blocs or a bloc and a state. Afghanistan Afghanistan has bilateral agreements with the following countries and blocs: * India * Pakistan Armenia Armenia has bilateral agreements with the following countries and blocs: * Commonwealth of Independent States **Belarus **Kazakhstan **Kyrgyzstan **Moldova **Russia **Turkmenistan **Tajikistan **Uzbekistan *Eurasian Economic Union **Eurasian Customs Union members ***Vietnam free trade agreement ***China trade ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Regional Trade Agreements
In geography, regions, otherwise referred to as zones, lands or territories, are areas that are broadly divided by physical characteristics ( physical geography), human impact characteristics ( human geography), and the interaction of humanity and the environment ( environmental geography). Geographic regions and sub-regions are mostly described by their imprecisely defined, and sometimes transitory boundaries, except in human geography, where jurisdiction areas such as national borders are defined in law. Apart from the global continental regions, there are also hydrospheric and atmospheric regions that cover the oceans, and discrete climates above the land and water masses of the planet. The land and water global regions are divided into subregions geographically bounded by large geological features that influence large-scale ecologies, such as plains and features. As a way of describing spatial areas, the concept of regions is important and widely used among the many ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
International Council For Harmonisation Of Technical Requirements For Pharmaceuticals For Human Use
The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is an initiative that brings together regulatory authorities and pharmaceutical industry to discuss scientific and technical aspects of pharmaceutical product development and registration. The mission of the ICH is to promote public health by achieving greater harmonisation through the development of technical Guidelines and requirements for pharmaceutical product registration. Harmonisation leads to a more rational use of human, animal and other resources, the elimination of unnecessary delay in the global development, and availability of new medicines while maintaining safeguards on quality, safety, efficacy, and regulatory obligations to protect public health. Junod notes in her 2005 treatise on Clinical Drug Trials that "Above all, the ICH has succeeded in aligning clinical trial requirements." History In the 1980s the European Union began harmonising regulatory requirem ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Good Manufacturing Practice
Current good manufacturing practices (cGMP) are those conforming to the guidelines recommended by relevant agencies. Those agencies control the authorization and licensing of the manufacture and sale of food and beverages, cosmetics, pharmaceutical products, dietary supplements, and medical devices. These guidelines provide minimum requirements that a manufacturer must meet to assure that their products are consistently high in quality, from batch to batch, for their intended use. The rules that govern each industry may differ significantly; however, the main purpose of GMP is always to prevent harm from occurring to the end user. Additional tenets include ensuring the end product is free from contamination, that it is consistent in its manufacture, that its manufacture has been well documented, that personnel are well trained, and that the product has been checked for quality more than just at the end phase. GMP is typically ensured through the effective use of a quality managemen ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
COVID-19 Pandemic
The COVID-19 pandemic, also known as the coronavirus pandemic, is an ongoing global pandemic of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The novel virus was first identified in an outbreak in the Chinese city of Wuhan in December 2019. Attempts to contain it there failed, allowing the virus to spread to other areas of Asia and later worldwide. The World Health Organization (WHO) declared the outbreak a public health emergency of international concern on 30 January 2020, and a pandemic on 11 March 2020. As of , the pandemic had caused more than cases and confirmed deaths, making it one of the deadliest in history. COVID-19 symptoms range from undetectable to deadly, but most commonly include fever, dry cough, and fatigue. Severe illness is more likely in elderly patients and those with certain underlying medical conditions. COVID-19 transmits when people breathe in air contaminated by droplets and ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Country Of Origin
Country of origin (CO) represents the sovereign state, country or countries of manufacture, production, design, or brand origin where an merchandise, article or product comes from. For multinational brands, CO may include multiple countries within the value-creation process. There are differing rules of origin under various national laws and international treaties. Country of origin labelling (COL) is also known as ''place-based branding'', the ''made-in image'' or the "nationality bias". In some regions or industries, country of origin labelling may adopt unique local terms such as terroir used to describe wine appellations based on the specific region where grapes are grown and wine manufactured. Place-based branding has a very ancient history. Archaeological evidence points to packaging specifying the place of manufacture dating back to some 4,000 years ago. Over time, informal labels evolved into formal, often regulated labels providing consumers with information about prod ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Legalization (international Law)
In international law, document legalization is the process of authenticating or certifying a document so it can be accepted in another country. Rationale and procedure Due to the lack of familiarity with foreign documents or the entities that issue them, many countries require that foreign documents be legalized to be accepted there. This legalization procedure generally consists of a chain of certifications, by one or more authorities of the country of origin of the document and of the destination country. The first authority certifies the issuer of the document, and each subsequent authority certifies the previous one, until the final certification is made by an authority of the destination country that can be recognized by the final user there.Apostille Handbook Hague Conference on Private International Law, 2 ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Apostille
The Convention of 5 October 1961 Abolishing the Requirement of Legalisation for Foreign Public Documents, also known as the Apostille Convention, is an international treaty drafted by the Hague Conference on Private International Law (HCCH). It is intended to simplify the procedure through which a document, issued in one of the contracting states, can be certified for legal purposes in all the other contracting states. A certification under the Convention is called an apostille or Hague apostille (from French ''apostille'', meaning a marginal or bottom note, from Latin ''post illa'', literally "after those ords of the text).Apostille Handbook Hague Conference on Private International Law, 2013. It is an international certification comparable to a [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Pharmaceutical Industry
The pharmaceutical industry discovers, develops, produces, and markets drugs or pharmaceutical drugs for use as medications to be administered to patients (or self-administered), with the aim to cure them, vaccinate them, or alleviate symptoms. Pharmaceutical companies may deal in generic or brand medications and medical devices. They are subject to a variety of laws and regulations that govern the patenting, testing, safety, efficacy using drug testing and marketing of drugs. The global pharmaceuticals market produced treatments worth $1,228.45 billion in 2020 and showed a compound annual growth rate (CAGR) of 1.8%. History Mid-1800s – 1945: From botanicals to the first synthetic drugs The modern era of pharmaceutical industry began with local apothecaries that expanded from their traditional role of distributing botanical drugs such as morphine and quinine to wholesale manufacture in the mid-1800s, and from discoveries resulting from applied research. Intentional drug ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
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