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Dr. Gaurav Kumar
PHARMD, C.P.P.M
5/21/2019DR. G.K SHARMA PHARM, CPPM, CGCPh1
European Medicines Evaluation
Agency (EMEA)
5/21/2019DR. G.K SHARMA PHARM, CPPM, CGCPh2
 European Medicines Agency (EMA) is a centralized government body whose goal is to promote and protect
human and animal health through overseeing the use of medications in European countries.
 The EMA, formerly called the European Agency for the Evaluation of Medicinal Products, is the European
Union’s equivalent to the U.S. Food and Drug Administration.
 Prior to 2004, it was known as the European Agency for the Evaluation of Medicinal
Products or EMEA. although this is not its official name.
 EMA is a decentralised agency of the European Union (EU), located in London. It began operating in 1995.
 The Agency is responsible for the scientific evaluation, supervision and safety monitoring of medicines
developed by pharmaceutical companies for use in the EU.
 EMA protects public and animal health in 28 EU Member States, as well as the countries of the European
Economic Area (EEA), by ensuring that all medicines available on the EU market are safe, effective and of
high quality.
 When a pharmaceutical company wants permission to sell a drug in certain parts of the world, it must get
permission first from the EMA. If the EMA grants approval, the drug can be used throughout the European
Union and in Iceland, Norway and Liechtenstein. The EMA also monitors the safety of medicines after they
have been approved, through a process called pharmacovigilance. Further, the EMA inspects clinics and
labs to make sure medicines are being tested and produced correctly. The EMA is not involved in research
and development (R&D), nor is it involved in clinical trial
5/21/2019DR. G.K SHARMA PHARM, CPPM, CGCPh3
 As of July 2018, the European Medicines Agency (EMA) publishes data from the Article 57 database on all
medicines authorized in the European Economic Area (EEA). Marketing authorization holders must submit
and maintain this information in accordance with European Union (EU) legislation.
 The document contains the following data fields:
a. Product name
b. Active substance
c. Route of administration
d. Country of authorization;
e. Name of the marketing authorization holder (company);
f. Country of location of the pharmacovigilance system master file;
g. Marketing authorization holder's contact email address and telephone number
for pharmacovigilance enquiries.
Agency composed
5/21/2019DR. G.K SHARMA PHARM, CPPM, CGCPh4
 The agency is composed of the Secretariat (ca. 600 staff), a management board, seven scientific committees
(human, veterinary and herbal medicinal products, orphan drugs, pediatrics, advanced therapies and
pharmacovigilance risk assessment) and a number of scientific working parties.
 The Management Board: provides including approval of budgets and plans, and selection of Executive
Director.
 The Board includes:
a. one representative of each of the 28 Member States,
b. two representatives of the European Commission,
c. two representatives of the European Parliament,
d. two representatives of patients' organizations,
e. one representative of doctors' organizations and
f. one representative of veterinarians' organizations.
The European System
5/21/2019DR. G.K SHARMA PHARM, CPPM, CGCPh5
 All medicines must have a marketing authorisation before they can be put on the market
Two ways of obtaining authorization:
 1) The centralized procedure or 2) National marketing authorization procedures
 Centralized Procedure EMA
 Mutual Recognition
 Decentralized Procedure National Procedures
 National Authorization
Benefits of the centralized procedure
5/21/2019DR. G.K SHARMA PHARM, CPPM, CGCPh6
Medicines approved via the centralised procedure
5/21/2019DR. G.K SHARMA PHARM, CPPM, CGCPh7
Centralized marketing authorisations
5/21/2019DR. G.K SHARMA PHARM, CPPM, CGCPh8
 The centralised procedure is compulsory for all medicines derived from biotechnology and other high-tech
processes, as well as for human medicines for the treatment of HIV/AIDS, cancer, diabetes,
neurodegenerative diseases, auto-immune and other immune dysfunctions, and viral diseases, and for
veterinary medicines for use for growth or yield enhancers. The centralised procedure is also open to
products that bring a significant therapeutic, scientific or technical innovation, or is in any other respect in
the interest of patient or animal health. As a result, the majority of genuinely novel medicines are
authorised through the EMA.
 For products eligible for or requiring centralised approval, a company submits an application for a
marketing authorisation to the EMA.
EMA’s scientific committees
5/21/2019DR. G.K SHARMA PHARM, CPPM, CGCPh9
 The EMA has seven scientific committees that carry out its scientific assessments:
1. Committee for Medicinal Products for Human Use (CHMP)
2. Pharmacovigilance Risk Assessment Committee (PRAC)
3. Committee for Medicinal Products for Veterinary Use (CMVP)
4. Committee for Orphan Medicinal Products (COMP)
5. Committee on Herbal Medicinal Products (HMPC)
6. Committee for Advanced Therapies (CAT)
7. Pediatric Committee (PDCO)
EMA does not control
5/21/2019DR. G.K SHARMA PHARM, CPPM, CGCPh10
1. Pricing of medicines
2. Access to medicines
3. Advertising of medicines
4. Patents on medicines
5. Medical devices
6. Homoeopathic medicines
7. Food supplements
8. Cosmetics
9. Tobacco

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European medicines evaluation agency

  • 1. Dr. Gaurav Kumar PHARMD, C.P.P.M 5/21/2019DR. G.K SHARMA PHARM, CPPM, CGCPh1 European Medicines Evaluation Agency (EMEA)
  • 2. 5/21/2019DR. G.K SHARMA PHARM, CPPM, CGCPh2  European Medicines Agency (EMA) is a centralized government body whose goal is to promote and protect human and animal health through overseeing the use of medications in European countries.  The EMA, formerly called the European Agency for the Evaluation of Medicinal Products, is the European Union’s equivalent to the U.S. Food and Drug Administration.  Prior to 2004, it was known as the European Agency for the Evaluation of Medicinal Products or EMEA. although this is not its official name.  EMA is a decentralised agency of the European Union (EU), located in London. It began operating in 1995.  The Agency is responsible for the scientific evaluation, supervision and safety monitoring of medicines developed by pharmaceutical companies for use in the EU.  EMA protects public and animal health in 28 EU Member States, as well as the countries of the European Economic Area (EEA), by ensuring that all medicines available on the EU market are safe, effective and of high quality.  When a pharmaceutical company wants permission to sell a drug in certain parts of the world, it must get permission first from the EMA. If the EMA grants approval, the drug can be used throughout the European Union and in Iceland, Norway and Liechtenstein. The EMA also monitors the safety of medicines after they have been approved, through a process called pharmacovigilance. Further, the EMA inspects clinics and labs to make sure medicines are being tested and produced correctly. The EMA is not involved in research and development (R&D), nor is it involved in clinical trial
  • 3. 5/21/2019DR. G.K SHARMA PHARM, CPPM, CGCPh3  As of July 2018, the European Medicines Agency (EMA) publishes data from the Article 57 database on all medicines authorized in the European Economic Area (EEA). Marketing authorization holders must submit and maintain this information in accordance with European Union (EU) legislation.  The document contains the following data fields: a. Product name b. Active substance c. Route of administration d. Country of authorization; e. Name of the marketing authorization holder (company); f. Country of location of the pharmacovigilance system master file; g. Marketing authorization holder's contact email address and telephone number for pharmacovigilance enquiries.
  • 4. Agency composed 5/21/2019DR. G.K SHARMA PHARM, CPPM, CGCPh4  The agency is composed of the Secretariat (ca. 600 staff), a management board, seven scientific committees (human, veterinary and herbal medicinal products, orphan drugs, pediatrics, advanced therapies and pharmacovigilance risk assessment) and a number of scientific working parties.  The Management Board: provides including approval of budgets and plans, and selection of Executive Director.  The Board includes: a. one representative of each of the 28 Member States, b. two representatives of the European Commission, c. two representatives of the European Parliament, d. two representatives of patients' organizations, e. one representative of doctors' organizations and f. one representative of veterinarians' organizations.
  • 5. The European System 5/21/2019DR. G.K SHARMA PHARM, CPPM, CGCPh5  All medicines must have a marketing authorisation before they can be put on the market Two ways of obtaining authorization:  1) The centralized procedure or 2) National marketing authorization procedures  Centralized Procedure EMA  Mutual Recognition  Decentralized Procedure National Procedures  National Authorization
  • 6. Benefits of the centralized procedure 5/21/2019DR. G.K SHARMA PHARM, CPPM, CGCPh6
  • 7. Medicines approved via the centralised procedure 5/21/2019DR. G.K SHARMA PHARM, CPPM, CGCPh7
  • 8. Centralized marketing authorisations 5/21/2019DR. G.K SHARMA PHARM, CPPM, CGCPh8  The centralised procedure is compulsory for all medicines derived from biotechnology and other high-tech processes, as well as for human medicines for the treatment of HIV/AIDS, cancer, diabetes, neurodegenerative diseases, auto-immune and other immune dysfunctions, and viral diseases, and for veterinary medicines for use for growth or yield enhancers. The centralised procedure is also open to products that bring a significant therapeutic, scientific or technical innovation, or is in any other respect in the interest of patient or animal health. As a result, the majority of genuinely novel medicines are authorised through the EMA.  For products eligible for or requiring centralised approval, a company submits an application for a marketing authorisation to the EMA.
  • 9. EMA’s scientific committees 5/21/2019DR. G.K SHARMA PHARM, CPPM, CGCPh9  The EMA has seven scientific committees that carry out its scientific assessments: 1. Committee for Medicinal Products for Human Use (CHMP) 2. Pharmacovigilance Risk Assessment Committee (PRAC) 3. Committee for Medicinal Products for Veterinary Use (CMVP) 4. Committee for Orphan Medicinal Products (COMP) 5. Committee on Herbal Medicinal Products (HMPC) 6. Committee for Advanced Therapies (CAT) 7. Pediatric Committee (PDCO)
  • 10. EMA does not control 5/21/2019DR. G.K SHARMA PHARM, CPPM, CGCPh10 1. Pricing of medicines 2. Access to medicines 3. Advertising of medicines 4. Patents on medicines 5. Medical devices 6. Homoeopathic medicines 7. Food supplements 8. Cosmetics 9. Tobacco