- Email: [email protected]
The Drug Approval Process in Europe☆
The Drug Approval Process in Europe☆ L Wecker, University of South Florida, Tampa, FL, USA J Krzanowski, USF College of Medicine, Tampa, FL, USA ã 2014 Elsevier Inc. All rights reserved.
The drug approval process in Europe is similar to the United States in that it involves review of results from laboratory, animal, and human testing to determine whether a potential therapeutic agent is safe, effective, and properly labeled. In addition, some countries require information on pricing before the drug is approved. The European Union (EU) has one central licensing authority, The European Agency for the Evaluation of Medicinal Products (EMEA), formerly known as the European Medicines Evaluation Agency. The EMEA was established in 1993 as a decentralized agency to coordinate scientific resources needed for evaluating products for human use in all 15-member states. Based on the recommendation of EMEA, the European Commission officially authorizes the marketing of new drugs. The purpose of EMEA, like that of the FDA in the United States, is to protect public health by evaluating medicinal agents and by monitoring the safety of medications. Thus, EMEA provides a centralized approval process that produces a single marketing authorization valid in all EU countries. Historically, countries throughout Europe have had specific requirements for patent protection and marketing, as well as for review of preclinical and clinical testing prior to drug approval. This resulted in a costly, inefficient, and redundant system that often results in significant delays in many parts of Europe. Thus, in 1990, an effort was made to bring together regulatory authorities from the EU (for a listing of member states and candidate countries of the EU, see http://europa.eu.int/), Japan, and the United States, as well as experts from the pharmaceutical industry in these geographical regions, to unify the drug approval process. The project was named The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The purpose of the ICH is to “make recommendations on ways to achieve greater harmonization in the interpretation and application of technical guidelines and requirements for product registration in order to reduce or obviate the need to duplicate the testing carried out during the research and development of new medicines” (http://www.ich.org/). Through this cooperative effort, the global availability and development of new drugs will be more efficient and more economical, while preserving the quality, safety, and regulatory obligations required to protect the public.
Relevant Websites http://www.ich.org/ – This site was developed to speed the introduction of new therapeutic agents and to reduce duplication of studies, thus conserving resources. Guidelines for quality, safety, efficacy, and multidisciplinary topics are presented. http://checknomics.com/industry-Pharmaceuticals-Regulations-Regulations_in_Europe.as – This site has information for purchase regarding: 1. Regulations in Europe. 2. Drug approval process in the EU, 3. Centralized procedure in the European pharmaceutical market, 4. Decentralized procedure in the European pharmaceutical market.
☆
Change History: August 2014. L Wecker and J Krzanowski updated websites.
Reference Module in Biomedical Research
http://dx.doi.org/10.1016/B978-0-12-801238-3.05351-4
1
The drug approval process in Europe is similar to the United States in that it involves review of results from laboratory, animal, and human testing to determine whether a potential therapeutic agent is safe, effective, and properly labeled. In addition, some countries require information on pricing before the drug is approved. The European Union (EU) has one central licensing authority, The European Agency for the Evaluation of Medicinal Products (EMEA), formerly known as the European Medicines Evaluation Agency. The EMEA was established in 1993 as a decentralized agency to coordinate scientific resources needed for evaluating products for human use in all 15-member states. Based on the recommendation of EMEA, the European Commission officially authorizes the marketing of new drugs. The purpose of EMEA, like that of the FDA in the United States, is to protect public health by evaluating medicinal agents and by monitoring the safety of medications. Thus, EMEA provides a centralized approval process that produces a single marketing authorization valid in all EU countries. Historically, countries throughout Europe have had specific requirements for patent protection and marketing, as well as for review of preclinical and clinical testing prior to drug approval. This resulted in a costly, inefficient, and redundant system that often results in significant delays in many parts of Europe. Thus, in 1990, an effort was made to bring together regulatory authorities from the EU (for a listing of member states and candidate countries of the EU, see http://europa.eu.int/), Japan, and the United States, as well as experts from the pharmaceutical industry in these geographical regions, to unify the drug approval process. The project was named The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The purpose of the ICH is to “make recommendations on ways to achieve greater harmonization in the interpretation and application of technical guidelines and requirements for product registration in order to reduce or obviate the need to duplicate the testing carried out during the research and development of new medicines” (http://www.ich.org/). Through this cooperative effort, the global availability and development of new drugs will be more efficient and more economical, while preserving the quality, safety, and regulatory obligations required to protect the public.
Relevant Websites http://www.ich.org/ – This site was developed to speed the introduction of new therapeutic agents and to reduce duplication of studies, thus conserving resources. Guidelines for quality, safety, efficacy, and multidisciplinary topics are presented. http://checknomics.com/industry-Pharmaceuticals-Regulations-Regulations_in_Europe.as – This site has information for purchase regarding: 1. Regulations in Europe. 2. Drug approval process in the EU, 3. Centralized procedure in the European pharmaceutical market, 4. Decentralized procedure in the European pharmaceutical market.
☆
Change History: August 2014. L Wecker and J Krzanowski updated websites.
Reference Module in Biomedical Research
http://dx.doi.org/10.1016/B978-0-12-801238-3.05351-4
1