Pharmaceutical Research and Manufacturers of America, formerly known as the Pharmaceutical Manufacturers Association, is a trade group representing companies in the pharmaceutical industry in the United States. Founded in 1958, PhRMA lobbies on behalf of pharmaceutical companies. PhRMA is headquartered in Washington, DC.
The European Medicines Agency (EMA) is an agency of the European Union (EU) in charge of the evaluation and supervision of pharmaceutical products. Prior to 2004, it was known as the European Agency for the Evaluation of Medicinal Products or European Medicines Evaluation Agency (EMEA).
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.
A biopharmaceutical, also known as a biological medical product, or biologic, is any pharmaceutical drug product manufactured in, extracted from, or semisynthesized from biological sources. Different from totally synthesized pharmaceuticals, they include vaccines, whole blood, blood components, allergenics, somatic cells, gene therapies, tissues, recombinant therapeutic protein, and living medicines used in cell therapy. Biologics can be composed of sugars, proteins, nucleic acids, or complex combinations of these substances, or may be living cells or tissues. They are isolated from living sources—human, animal, plant, fungal, or microbial. They can be used in both human and animal medicine.
The pharmaceutical industry is one of the leading industries in the People's Republic of China, covering synthetic chemicals and drugs, prepared Chinese medicines, medical devices, apparatus and instruments, hygiene materials, packing materials, and pharmaceutical machinery. China has the second-largest pharmaceutical market in the world as of 2017 which is worth US$110 billion. China accounts for 20% of the world's population but only a small fraction of the global drug market. China's changing health-care environment is designed to extend basic health insurance to a larger portion of the population and give individuals greater access to products and services. Following the period of change, the pharmaceutical industry is expected to continue its expansion.
C.H. Boehringer Sohn AG & Co. KG is the parent company of the Boehringer Ingelheim group, which was founded in 1885 by Albert Boehringer (1861–1939) in Ingelheim am Rhein, Germany. As of 2018, Boehringer Ingelheim is one of the world's largest pharmaceutical companies, and the largest private one. Headquartered in Ingelheim, it operates globally with 146 affiliates and more than 47,700 employees. Unlike most large pharmaceutical companies which are listed, the company is private and fully owned by the Boehringer, Liebrecht and von Baumbach families. The company's key areas of interest are: respiratory diseases, metabolism, immunology, oncology and diseases of the central nervous system. Boehringer Ingelheim is a full member of the European Federation of Pharmaceutical Industries and Associations (EFPIA). The corporate logo of Boehringer Ingelheim depicts a stylized rendition of the central section of the imperial palace of Charlemagne.
The pharmaceutical industry in India was valued at an estimated US$42 billion in 2021 and is estimated to reach $130 billion by 2030. India is the world's largest provider of generic medicines by volume, with a 20% share of total global pharmaceutical exports. It is also the largest vaccine supplier in the world by volume, accounting for more than 60% of all vaccines manufactured in the world. Indian pharmaceutical products are exported to various regulated markets including the US, UK, European Union and Canada.
EuropaBio is Europe's largest and most influential biotech industry group, whose members include leading large-size healthcare and industrial biotechnology companies. EuropaBio is located in Brussels, Belgium. The organisation was initiated in 1996 to represent the interests of the biotechnology industry at the European level, and therefore influence legislation that serves the interests of biotechnology companies in Europe.
The International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) is a trade association that represents internationally over 90 leading innovative pharmaceutical companies and associations around the world. IFPMA is based in Geneva and is in official relations with the United Nations where it contributes industry expertise to global health discussions.
Servier Laboratories is an international pharmaceutical company governed by a non-profit foundation, with its headquarters in France (Suresnes).
The Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S) are two international instruments between countries and pharmaceutical inspection authorities. The PIC/S is meant as an instrument to improve co-operation in the field of Good Manufacturing Practices between regulatory authorities and the pharmaceutical industry.
Good automated manufacturing practice (GAMP) is both a technical subcommittee of the International Society for Pharmaceutical Engineering (ISPE) and a set of guidelines for manufacturers and users of automated systems in the pharmaceutical industry. More specifically, the ISPE's guide The Good Automated Manufacturing Practice (GAMP) Guide for Validation of Automated Systems in Pharmaceutical Manufacture describes a set of principles and procedures that help ensure that pharmaceutical products have the required quality. One of the core principles of GAMP is that quality cannot be tested into a batch of product but must be built into each stage of the manufacturing process. As a result, GAMP covers all aspects of production; from the raw materials, facility and equipment to the training and hygiene of staff. Standard operating procedures (SOPs) are essential for processes that can affect the quality of the finished product.
The European Federation of Biotechnology (EFB) was established by European scientists in 1978. It is a non-profit federation of national biotechnology associations, learned societies, universities, scientific institutes, biotechnology companies and individual biotechnologists working to promote biotechnology throughout Europe and beyond.
Merck Serono is a pharmaceutical company headquartered in Darmstadt, Germany, and a brand and division of Merck focused on biopharmaceuticals.
The Innovative Medicines Initiative (IMI) is a European initiative to improve the competitive situation of the European Union in the field of pharmaceutical research. The IMI is a joint initiative of the DG Research of the European Commission, representing the European Communities, and the European Federation of Pharmaceutical Industries and Associations (EFPIA). IMI is laid out as a Joint Technology Initiative within the Seventh Framework Programme. Michel Goldman was the first executive director, from September 2009 until December 2014.
Biotechnology in India is a sunrise sector within the Indian economy. Agencies of the Government of India concerned with the biotechnology industry include the Department of Biotechnology and the proposed Biotechnology Regulatory Authority of India. As of 2022, the sector is valued at $80 billion. Biotechnology in India is in a growth phase and the sector is expected to be valued at $150 billion by 2025 and surpass $300 billion in value by 2030.
The Biotechnology Innovation Organization (BIO) is the largest advocacy association in the world representing the biotechnology industry. It was founded in 1993 as the Biotechnology Industry Organization from a merger of the Industrial Biotechnology Association (IBA) and the Association of Biotechnology Companies (ABC), and changed its name to the Biotechnology Innovation Organization on January 4, 2016. Biotechnology Innovation Organization serves more than 1,100 biotechnology firms, research schools, state biotechnology centers and related associations in the United States and in more than 30 other countries.
The Faculty of Pharmacy, Universidade de Lisboa (FFUL) is a Portuguese public institution of higher education dedicated to education, research, knowledge transfer and continuing education in the fields of pharmacy, medicine, and pharmaceutical sciences.
Emer Cooke is an Irish pharmacist and Executive Director of the European Medicines Agency (EMA) since November 2020. She is also the chairperson at the International Coalition of Medicines Regulatory Authorities (ICMRA).
BIOTECanada, or the Industrial Biotechnology Association of Canada, is a Canadian biotechnology industry association based in Ottawa, Ontario. It is an industry-funded membership organization composed of over 250 national and international pharmaceutical and gene therapy companies, medical device manufacturers, agricultural science businesses, law firms, academic institutions, research and development networks, advertising agencies, insurance companies and financial services firms.
