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: As part of its contribution to promoting global health, the European Medicines Agency can assess medicines for use outside the European Union (EU) and issue scientific opinions in collaboration with the World Health Organization and non-EU national regulatory authorities. Ten positive scientific opinions have been adopted by the Committee for Medicinal Products for Human Use of the European Medicines Agency medicines (EU-M4all, or article 58). We have investigated for the first time their impact.: We included all positive scientific opinions (n = 10), contacted the sponsors (n = 8) and obtained and analyzed the lists of approval granted based on these opinions.: 138 regulatory approvals have been granted in 90 countries, with 75 approvals in Africa, and the remainder in Latin and South America, Middle East and South-East Asia, and non-EU Europe and Central Asia.: These scientific opinions reflect the conditions of use and rely on high standards, but the final approval decision remains with these countries. Despite the small number of EU-M4all opinions, the many approvals have had an impact and contribute to access to innovation for patients with unmet needs in target countries.
This article was published in the following journal.
Name: Expert review of clinical pharmacology
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An application that must be submitted to a regulatory agency (the FDA in the United States) before a drug can be studied in humans. This application includes results of previous experiments; how, where, and by whom the new studies will be conducted; the chemical structure of the compound; how it is thought to work in the body; any toxic effects found in animal studies; and how the compound is manufactured. (From the "New Medicines in Development" Series produced by the Pharmaceutical Manufacturers Association and published irregularly.)
Medicines whose effectiveness is unproven and whose ingredients are often secret.
The study of medicines derived from botanical sources.
Medicines that can be sold legally without a DRUG PRESCRIPTION.
Histamine H1 antagonist used in allergic rhinitis; ASTHMA; and URTICARIA. It is a component of COUGH and COLD medicines. It may cause drowsiness.
Alliances Astrazeneca Bioethics Boehringer Clinical Research Organization Collaborations GSK Johnson & Johnson Lilly Merck Mergers and Acquisitions Nexium Novartis Pfizer Roche Sanofi ...