1. GUIDED BY:-
Dr. RAJESH K S
Principle
PREPARED BY:-
DINESH KUMAR
M.Pharm.:-3nd Sem. QA.
IST Shift
Enroll. No.:- 132330804003
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2. Table of content
The European Union – In Perspective
The EU Today
The EU – Areas of Responsibility
Responsible EU Institutions
EU Pharmaceutical Legislation
Why is There EU Pharmaceutical Legislation?
What is a Competent Authority in the European
Union?
Responsibilities of the Competent Authorities
EMEA Scientific Committees
CHMP,CVMP,COMP,HMPC,PDCO,CAT & PRAC.
CHMP Working Parties
Current CHMP Scientific Advisory Groups (SAG)
European Medicines Network
Routes to License in the EU and its Member States
3. Centralized Procedure
Mutual Recognition
Decentralized Procedure
The European Directorate for the Quality of
Medicines and Healthcare (EDQM)
INDIAN PHARMACEUTICAL REGULATORY
ENVIRONMENT
Their regulatory bodies
References
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4. The European Union– In Perspective
Began in the 1950s as the European Economic
Community (EEC) with six founding members
Belgium
Germany
France
Italy
Luxembourg
The Netherlands(1)
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5. The EU Today
EU Member States comprise 28 countries and a total
population of 501,259,840 (Eurostat 8 Jan 2010)
Austria Hungary Slovakia
Belgium Ireland Slovenia
Bulgaria Italy Spain
Cyprus Latvia Sweden
Czech republic Lithuania U.K
Denmark Luxembourg
Estonia Malta
Finland Netherland
France Poland
Germany Portugal
Greece Romania (1)
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8. The EU – Areas of Responsibility
European union(EU) responsible for legislating
and enforcing laws in all industries (including
pharmaceutical and medical devices)
Finance
Energy
Environment
Transportation
Public health
Regional policy
Indirect taxation
Agriculture
Fisheries(1)
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9. Responsible EU Institutions
European Commission
Executive Branch
Drafting of legislative proposals
Represents the “community”
Organized into Directorates General
European Council
Senior members (heads of State or ministers)
Represents Member States
European Parliament
Elected officials
Represents the “citizenry”
EU Courts(1)
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10. EU Pharmaceutical Legislation
Directive 2001/83EC: Community on
Medicinal Products for Human Use
No medicinal products may be placed on the
market of a Member State.
unless an authorization has been issued by the
competent authorities of that Member State or by
the European Medicines Agency (EMA).
An authorization holder may submit a request for
recognition of this authorization to other Member
States.(1)
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11. Regulation (EC) 726/2004: Centralized
procedure and the functioning of the
European Medicines
The European Parliament and the Council of a
centralized Community procedure for the
authorization of medicinal products.
which there is a single application, a single
evaluation and a single authorization allowing
direct access to the single market of the
community.(1)
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12. Why is There EU Pharmaceutical Legislation
Safeguard the Public Health
Improve Functioning of the Internal Market
Establish uniform rules for the performance of
tests and
Trials on medicines to ensure therapeutic efficacy
Provide faster access to innovative products
Boost competiveness of EU-based Pharmacy
industry
Meet challenges of the global marketplace(1)
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13. What is a Competent Authority in the EuropeanUnion?
Any organization within a Member State (MS) with
legally delegated authority or power to perform a
designated function
That function can be in one of numerous
commercial areas, for example:
Human medicines
Veterinary medicines
Medical devices
Blood transfusion services
Consumer products
Food(2)
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14. Within the Member States of the European
Union Case have very different structures and
organizations:
Some MS have separate CA for human and
veterinary medicines (e.g. UK, France and
Hungary)
Some MS have a single CA for human and
veterinary medicines(e.g. Netherlands and
Ireland)
Some MS have separate CA for small
molecule based medicines and biologically
based medicines (e.g. Germany)
Currently there are 48 Competent Authorities
which support the EMA.(2)
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15. Responsibilities of the CompetentAuthorities
Primary responsibilities of CA include:
License for human and veterinary medicinal
products via the National (MS) and Decentralized
routes
Performing good practice inspections
Pharmacovigilance
Providing expert resource to the EMA, such as:
Membership of EMA Scientific Committees (CHMP,
CVMP, COMP, PDCO, etc.)
Membership of CHMP Working Parties (Currently
12 ‘Permanent’ + 1 Temporary)
Membership of Scientific Advisory Groups (SAGs)
Acting as Reporter / Co-Reporter for Centralized
Marketing Authorization Applications(2)
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16. Acting as Reference Member State for Mutual
Recognition Applications
Acting as Reference Member State for
Decentralized Marketing Authorization
Applications(2)
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17. EMEAScientificCommittees
CHMP - Committee for Medicinal Products for
Human Use
CVMP - Committee for Medicinal Products for
Veterinary Use
COMP - Committee for Orphan Medicinal Products
PDCO - Pediatric Committee
CAT - Committee for Advanced Therapies
HMPC - Committee on Herbal Medicinal Products
PRAC – Pharmacovigilance Risk Assessment
Committee (4)
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18. CHMP - Committee for Medicinal Productsfor Human Use
Composition
The members and alternates of the CHMP are
nominated by European Union Member States in
consultation with the Agency's Management
Board.
They serve on the Committee for a renewable
period of three years.
The CHMP is composed of:
a chairman, elected by serving CHMP members;
one member and an alternate nominated by each
of the 28 Member States;
one member and an alternate nominated by
Iceland and by Norway;
up to five co-opted members nominated by
Member States or the Agency.(4)
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19. Function
responsible for preparing opinions on questions
concerning medicines for human use.
Developing a new medicinal products.
The preparation of scientific and regulatory
guidelines for the pharmaceutical industry.
Cooperation with international partners on the
harmonization of regulatory requirements for
medicines.(4)
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20. CVMP - Committee for Medicinal Products for Veterinary Use
Composition
The members and alternates of the CVMP are nominated
by the European Union Member States, in consultation
with the Agency's Management Board.
They serve on the Committee for a renewable period of
three years.
The CVMP is composed of:
a chairman, elected by serving CVMP members;
one member and an alternate nominated by each of the
28 Member States;
one member and an alternate nominated by Iceland and
by Norway;
up to five co-opted members nominated by Member
States or the Agency.
Function
responsible for preparing opinions on questions
concerning medicines for veterinary use.(4)
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21. COMP- Committee for OrphanMedicinal Products
This designation is for medicines to be developed
for the diagnosis, prevention or treatment of rare
diseases that are life-threatening or very
serious.
Composition
The members of the COMP are nominated by
the EU Member States, in consultation with the
Agency's Management Board.
Six members are nominated by the European
Commission (To represent patient organizations).
All members serve on the Committee for a
renewable period of three years.(4)
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22. The COMP is composed of:
a chair, elected by serving COMP members;
one member nominated by each of the 28 Member
States;
three members nominated by the European
Commission to represent patients' organizations;
three members nominated by the European
Commission on the Agency's recommendation;
one member nominated by Iceland and one by
Norway.
Function
responsible for reviewing applications from people
or companies seeking 'orphan-medicinal-product
designation'.(4)
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23. PDCO- PediatricCommittee
The PDCO was established in accordance with the
Paediatric Regulation (Regulation (EC) 1901/2006 as
amended).
The members of the PDCO are appointed for a renewable
period of three years.
Composition
The PDCO is composed of
The chair is elected from its members.
five members appointed by the CHMP itself;
one member and one alternate appointed by each
European Union (EU) Member State
three members and alternates representing healthcare
professionals;
three members and alternates representing patient
associations
Function
responsible for assessing the content of pediatric
investigation plans.(4)
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24. CAT - Committee for Advanced Therapies
It was established in accordance with Regulation (EC)
No 1394/2007 on ATMPs.
Composition
The members of the CAT are appointed for a renewable
period of three years.
The chair and vice-chair are elected from its members
for a term of three years, which may be renewed once.
The CAT is composed of:
five members appointed by the CHMP itself;
one member and one alternate appointed by each
European Union (EU) Member State
two members and two alternates appointed by the
European Commission to represent clinicians;
two members and two alternates appointed by the
European Commission to represent patient associations.
Function
responsible for assessing the quality, safety and efficacy
of advanced-therapy medicinal products (ATMPs) and
following scientific developments in the field.(4) 24
25. HMPC - Committee on Herbal Medicinal Products
It was established in September 2004, replacing the
Committee for Proprietary Medicinal Products.
Composition
The members of the HMPC are scientific experts in the field
of herbal medicines.
One member and one alternate member nominated by
each of the 28 EU Member States and by Iceland and
Norway.
The chair is elected by serving HMPC members.
Up to five additional members nominated by the Member
States or by the Agency. The members are expertise in;
clinical pharmacology;
experimental / non-clinical pharmacology;
toxicology;
pediatric medicine;
general and family medicine.
Function
responsible for preparing the Agency's opinions on herbal
medicines.(4)
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26. PRAC – Pharmacovigilance Risk Assessment Committee
The PRAC's recommendations are considered by the
Committee for Medicinal Products for Human Use
(CHMP)
Composition
The members and alternates of the PRAC are
nominated by European Union Member States, in
consultation with the Agency's Management Board.
The European Commission also appoints six
independent scientific experts.
All serve on the Committee for a period of three
years which is renewable once.(4)
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27. The PRAC is composed of:
a chair and a vice chair, elected by serving PRAC
members;
one member and an alternate nominated by each of
the 28 Member States;
one member and an alternate nominated by Iceland
and by Norway;
one member and an alternate nominated by the
European Commission to represent healthcare
professionals;
one member and one alternate nominated by the
European Commission to represent patients
organizations.
Function
responsible for assessing and monitoring safety
issues for human medicines.(4)
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28. CHMP Working Parties
Biologics Working Party (BWP)
Blood Products Working Party (BPWP)
Cell-based Products Working Party (CPWP)
Efficacy Working Party (EWP)
Gene Therapy Working Party (GTWP)
Joint CHMP/CVMP Quality Working Party (QWP)
Patients' and Consumers' Working Party (PCWP)
Phamacogenomics Working Party (PgWP)
Pharmacovigilance Working Party (PhVWP)
Safety Working Party (SWP)
Scientific Advice Working Party (SAWP)
Vaccine Working Party (VWP)
Similar Biological Medicinal Products Working
Party (BMWP)
SAWP - The Scientific Advice Working Party(3)
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29. EuropeanMedicines Network
CA form one part of what is known as the
European Medicines Network
This network includes:
The EMA, as the overall coordinator of existing
scientific resources in the MS
The CAs (> 40)
The list of European Experts
European Directorate for the Quality of Medicines
and Healthcare (EDQM)
Official Medicines Control Laboratories (OMCLs) in
Member States(3)
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30. Routes to License in the EU and its Member States
Centralized Procedure
Mutual Recognition
Decentralized Procedure (1)
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31. CentralizedProcedure
Managed solely through the CHMP
One Marketing Authorization covering all MS & EEA
issued by the EU Commission
o The Centralized Procedure is mandatory for certain
products and issues:
New products and therapeutic classes (e.g., AIDs,
cancer, neurodegenerative disorder, diabetes,
autoimmune diseases and viral diseases)
Medicinal products manufactured by a biotech
process such as:
Recombinant DNA technology
Controlled expression of genes coding for active
proteins
Hybridoma and monoclonal antibody methods(1)
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33. Mutual Recognitionand DecentralizedSystems
Both pathways essentially governed by one
Directive
Pathways used for:
New active substance (if not obliged to file
centrally)
Line extensions to existing Mutual Recognition
products
Generic applications (for nationally and centrally
authorized reference products)
New combinations of known actives
By consent applications
Well established use products
Homeopathic and herbals
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34. How to determine the pathway
Mutual Recognition – when your product already
has a Market Authorization in a Member State
Decentralized – when your product does not yet
have a Market Authorization in a Member State(1)
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35. The European Directoratefor the Qualityof Medicines and Healthcare
(EDQM)
EDQM is involved in medicines control, including
laboratory facilities, at a wider European level
The Council of Europe this work co-ordinates
activities in 47 countries
These activities include:
Responsibility for the European Pharmacopoeia
Co-ordinating the OMCL network
Co-ordinating other medicines control activities
via national agencies, inspectorates etc.
Operation of the Certificates of Suitability
Blood Transfusion and Organ Transplantation
Pharmaceuticals and Pharmaceutical Care(1)
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36. INDIANPHARMACEUTICALREGULATORY ENVIRONMENT
The principal regulatory body involved in the
approval of manufacture, drug development and
marketing of quality drugs in India.
The Central Drug Standards and Control
Organization (CDSCO) under Ministry of Health
and Family Welfare which works on developing
standards and measures for ensuring the safety,
efficacy and quality of drugs, cosmetics,
diagnostics and devices in the country.
It regulates the market authorization of new drugs
and clinical trials standards; supervises drug
imports and approves licenses to manufacture the
products.
At the state level, state drug regulatory authority
issues licences to manufacture approved drugs and
to monitor the quality of drugs along with
CDSCO.(5)
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37. The regulatory bodies involved in the
pharmaceutical industry and their functions are as
follows:
Drugs Control General of India (DCGI )- Main
authority for clinical trials, ensures standards,
registers all imported drugs, new drugs, biologics
and medical devices.
Indian Council of Medical Research (ICMR)-
main center for biomedical research.
Genetic Engineering Approval Committee
(GEAC)- deals with genetic engineering and
molecular biology, trials in which biotech products
are used will be referred here by DCGI.
Department of Biotechnology (DBT)-oversees
the development of modern biology and
biotechnology in India.
Atomic Energy Review Board (AERB)- has
regulatory control over radiation equipment.
Baba Atomic Research Centre (BARC)-
approves all radiation related projects and radio
pharmaceuticals in India.(5) 37
38. GOVT. OF INDIA
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Ministry of
health &family
weifare
Ministry of
chemicals
&fertilizers
Ministry of
commerse
Ministry of
science &
technology
DGHS Dept. of
Pharmaceuticals
Patent office ICMR
DCGI NPPA Controller general
of patents
DBT
DTAB CSIR
CDSCO
39. Drugs Consultative Committee (DCC)-
provides technical guidance to the CDSCO.
Central Drugs Laboratory (CDL)-maintains
quality control of drugs
Central License Approving Authority (CLAA)-
provides approval for manufacturing licenses’
Drugs Technical Advisory Board (DTAB) –
Provides technical guidance to the CDSCO
National Pharmaceutical Pricing Authority
(NPPA)- NPPA fixes or revises the prices of
decontrolled bulk drugs and formulations and
periodically updates the list under price control
according to guidelines.(5)
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40. References
1. joel.falk@weinberggroup.com
2. The Council of the European Union, press
release, 14 April 2014
3. http://europa.eu.int/eur-lex
4. shttp://www.emea.eu.int/index/-indexh1.htm
5. http://www.jli.edu.in/blog/trends-of-the-indian-
pharmaceutical-regulatory-system
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