How the European Medicines Agency Evaluates and Approves New Life-Saving Drugs
Following the rapid recommendation of the pancreatic cancer treatment Rasonque, which doubles survival rates for patients, families across Europe are watching the regulatory process closely. For people waiting on medical breakthroughs, understanding how these treatments move from the laboratory to the clinic is essential.
The European Medicines Agency was established in 1995 to harmonize the evaluation of medicines across EU member states, according to Wikipedia. Prior to 2004, it was known as the European Agency for the Evaluation of Medicinal Products or the European Medicines Evaluation Agency. The agency was set up with funding from the European Union and the pharmaceutical industry, as well as indirect subsidies from member states. Its stated intention was to harmonize the work of existing national medicine regulatory bodies rather than replace them, according to Wikipedia. The hope behind this plan was to reduce the 350 million euro annual cost that drug companies incurred by having to win separate approvals from each member state. It was also designed to eliminate the protectionist tendencies of sovereign states unwilling to approve new drugs that might compete with domestic products, according to Wikipedia. The agency was located in London prior to the United Kingdom vote for withdrawal from the European Union, relocating to Amsterdam in March 2019, according to Wikipedia.
The European Medicines Agency operates as a decentralised scientific agency, according to Wikipedia. Its primary responsibility is the protection and promotion of public and animal health through the evaluation and supervision of medicines for human and veterinary use, according to Wikipedia. The agency is composed of a secretariat with about 600 staff, a management board, and seven specialized scientific committees, according to Wikipedia. These committees cover human, veterinary and herbal medicinal products, orphan drugs, paediatrics, advanced therapies, and pharmacovigilance risk assessment, according to Wikipedia. The Committee for Medicinal Products for Human Use issues scientific opinions on whether drugs should be authorized, according to Wikipedia and the European Medicines Agency. The management board provides administrative oversight, including approval of budgets and plans, and the selection of the executive director, according to Wikipedia.
Standard drug evaluations can take up to 210 active days, and usually take around a year overall including the time required for a company to respond to questions, according to the European Medicines Agency. However, the agency can accelerate this timeline for high-priority medicines. For the pancreatic cancer drug Rasonque, the European Medicines Agency used a phased review process, according to the European Medicines Agency. Rasonque was identified as a high-priority medicine under the agency’s Cancer Medicines Pathfinder project because it addresses an urgent medical need, according to the European Medicines Agency. Phased reviews allow the Committee for Medicinal Products for Human Use to evaluate data in stages as they are submitted by the manufacturer, starting several months before the anticipated submission of the complete application, according to the European Medicines Agency. For Rasonque, the European Medicines Agency evaluated quality, non-clinical, and clinical data in phases, shortening the assessment time to less than 150 days while maintaining standards for quality, safety, and effectiveness, according to the European Medicines Agency and Il Sole 24 Ore.
An initial positive scientific recommendation from the European Medicines Agency is a major milestone, but it is not the final hurdle for patients seeking access to treatment, according to Il Sole 24 Ore. Once final authorization has been granted by the European Medicines Agency, individual national governments must still negotiate the final price and availability of the drug within their healthcare systems, according to Il Sole 24 Ore. Additional challenges can also arise from manufacturing capacity and international pricing policies, such as the Most Favoured Nation policy discussed in the United States, according to Il Sole 24 Ore. For families navigating these complex treatments, consulting a qualified doctor remains the most important step in understanding available options and personal care plans.
History And Structure Of The European Medicines Agency
The European Medicines Agency was established in 1995, with funding from the European Union and the pharmaceutical industry, as well as indirect subsidies from member states, according to Wikipedia. The agency was set up to harmonize the evaluation of medicines across EU member states, and its stated intention was to harmonize the work of existing national medicine regulatory bodies rather than replace them.
The EMA was founded after more than seven years of negotiations among EU governments and replaced the Committee for Proprietary Medicinal Products and the Committee for Veterinary Medicinal Products, though both of these were reborn as the core scientific advisory committees, according to Wikipedia. The agency operates as a decentralized scientific agency, with its main responsibility being the protection and promotion of public and animal health through the evaluation and supervision of medicines for human and veterinary use.
The agency is composed of a secretariat with about 600 staff, a management board, and seven specialized scientific committees, including human, veterinary and herbal medicinal products, orphan drugs, pediatrics, advanced therapies, and pharmacovigilance risk assessment, according to Wikipedia. The management board provides administrative oversight, including approval of budgets and plans, and the selection of the executive director.
Scientific Committee Structure and Function
The European Medicines Agency operates as a decentralised scientific agency with a secretariat of about 600 staff, a management board, and seven specialized scientific committees, according to Wikipedia. These committees cover human, veterinary and herbal medicinal products, orphan drugs, paediatrics, advanced therapies, and pharmacovigilance risk assessment, as stated in the source material. The Committee for Medicinal Products for Human Use (CHMP) issues scientific opinions on whether drugs should be authorized, according to both Wikipedia and the European Medicines Agency.
The management board provides administrative oversight, including approval of budgets and plans, and the selection of the executive director, according to Wikipedia. The agency’s structure is designed to coordinate the evaluation and monitoring of centrally authorised products and national referrals, develop technical guidance, and provide scientific advice to sponsors, as outlined in the Wikipedia entry. This framework supports the agency’s main responsibility of protecting and promoting public and animal health through the evaluation and supervision of medicines for human and veterinary use.
Sources
- Pancreatic cancer: Europe gives initial approval to a drug that doubles survival rates
- European Medicines Agency
- EMA recommends authorisation of Rasonque for metastatic pancreatic cancer | European Medicines Agency (EMA)
Photo: Ceescamel / wikimedia (CC BY-SA 4.0)
