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.
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.
Servier Laboratories is an international pharmaceutical company governed by a non-profit foundation, with its headquarters in France (Suresnes).
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.
Johnson & Johnson Pharmaceutical Research and Development (J&JPRD) is a subsidiary of Johnson & Johnson that is responsible for discovering and developing pharmaceutical drugs. J&JPRD has research sites located in Raritan, New Jersey, Titusville, New Jersey, Spring House, Pennsylvania, La Jolla, California, Beerse, Belgium and Toledo, Spain.
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.
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.
Valneva COVID-19 vaccine is a COVID-19 vaccine developed by French biotechnology company Valneva SE in collaboration with the American biopharmaceutical company Dynavax Technologies.
SARS-CoV-2, the virus that causes COVID-19, was isolated in late 2019. Its genetic sequence was published on 11 January 2020, triggering an urgent international response to prepare for an outbreak and hasten the development of a preventive COVID-19 vaccine. Since 2020, vaccine development has been expedited via unprecedented collaboration in the multinational pharmaceutical industry and between governments. By June 2020, tens of billions of dollars were invested by corporations, governments, international health organizations, and university research groups to develop dozens of vaccine candidates and prepare for global vaccination programs to immunize against COVID‑19 infection. According to the Coalition for Epidemic Preparedness Innovations (CEPI), the geographic distribution of COVID‑19 vaccine development shows North American entities to have about 40% of the activity, compared to 30% in Asia and Australia, 26% in Europe, and a few projects in South America and Africa.
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.
