Presentation on EU Regulatory & Quality System.

This presentation is compiled by “ Drug Regulations”
a non profit organization which provides free online
resource to the Pharmaceutical Professional.
Visit http://www.drugregulations.org for latest
information from the world of Pharmaceuticals.
10/17/2015 1

This presentation is compiled from freely available
resource like the website of EMA & EU.
“Drug Regulations” is a non profit organization
which provides free online resource to the
Pharmaceutical Professional.
10/17/2015 2
Drug Regulations : Online Resource for Latest Information

 The regulatory system for supervision of
pharmaceutical manufacturers and GMP
inspection in the European Union is one of the
most advanced in the world.
 This system is often poorly understood outside
the EU nations
 This presentation gives an explanation of the
EU system.
10/17/2015 3Drug Regulations : Online Resource for Latest Information

 The European Union includes 28 Member States
located in Europe, which are:
◦ Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic,
Denmark, Estonia, Finland, France, Germany, Greece,
Hungary, Ireland, Italy, Latvia, Lithuania, Luxemburg, Malta,
Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia,
Spain, Sweden, and United Kingdom.
 The EU total population is about 500 million
people.

 The European Union operates through a system of
◦ Supranational independent institutions and
◦ Intergovernmental negotiated decisions by its Member
States.
 It is a legal entity and can negotiate international
agreements on behalf of its Member States.

 Three main EU institutions.
◦ The European Parliament,
◦ The Council of the European Union and
◦ The European Commission
 Ordinary Legislative Procedure
◦ Produces Policies and laws that apply throughout the
European Union are formulated by this process.
 (formerly "co-decision")

 The European Union has developed a single market
◦ Standardized system of laws that apply in all its Member
States.
 Authorization of medicines and the supervision of
safety of medicines.
◦ Same rules and harmonized procedures apply to all the 28
Member States

 Regulatory system based on a network of
decentralized National Competent Authorities
(NCAs) in the Member States,
 Supported and coordinated by a centralized
agency, the European Medicines Agency. (EMA).
◦ Link to EMA website

 The EMA was created in 1995 to coordinate the existing
scientific resources in the EU Member States
 EMA: an interface for cooperation and coordination of
Member States’ activities with respect to medicinal products.
 EMA scientific decisions are made through its scientific
committees.
◦ Members are chosen on the bases of their scientific expertise and are
appointed by the Member States.
 One of the main roles of EMA is to mobilize scientific
resources in the Member States.
◦ Many of its scientific activities are carried out through a large network of
scientific experts made available by the Member States.

 The European Commission’s role is multifaceted and focuses on the
following:
◦ Right of initiative: To propose new or amending legislation for the pharmaceutical
sector
◦ Implementation: To adopt implementing measures as well as to ensure and monitor
the correct application of EU law
◦ Risk management: To grant EU-wide marketing authorizations for centralized
products or maximum residue limits on the basis of a scientific opinion of the EMA
Supervisory authority:
◦ To oversee the activities of the EMA in compliance with the mandate of the EMA, EU
law and the EU policy objectives Global outreach:
◦ To ensure appropriate collaboration with relevant international partners and to
promote the EU system globally

 System for Marketing Authorization (MA) of medicines & the
referral procedure,
 European Commission, the EMA and the Member States
cooperate to a great extent in its implementation
 The EU national, decentralized and mutual recognition MA
procedures coexist with the centralized procedure
◦ Marketing Authorization Procedure
◦ See table in next slide.

 An EU binding mechanism
◦ Ensures that the same measures are applied to products subject to
national, decentralized and mutual recognition MA procedures.
 This procedure may be notably invoked when
◦ The conditions of authorizations need to be reviewed in the light of
quality, safety and efficacy data (Union Interest Referral),
◦ Member States have adopted different decisions regarding products that
are authorized in at least two Member States (Divergent Decision Referral).
◦ In the absence of agreement among Member States in the course of the
mutual recognition or decentralized authorization procedures
 (Mutual Recognition and Decentralised Referral).

 This mechanism involves an opinion from the appropriate
EMA committee.
 Results in a decision of the European Commission that is
binding for all Member States
 See link for details

 Fundamental aspect
 Legislation applicable to pharmaceuticals in the European
Union is the same irrespective of the Member State or
authorization route of the product, as it is developed at Union
level.
 See the link

 Clinical trials of Investigational Medicinal Products (IMPs)
require
◦ Authorization by each NCA and
◦ A favorable opinion by an ethics committee in which the clinical trial takes
place and is granted in the form of a Clinical Trial Authorization (CTA)
◦ (http://ec.europa.eu/health/human-use/clinical- trials/index_en.htm).
 The assessment for a CTA takes into account the holding of
an appropriate authorization for each EU site of manufacture
or importation.

 Any manufacturer, no matter where it is located, must comply
with GMP if they are to supply products to the EU.
 There is a single system for GMP supervision of
manufacturers which is valid throughout all the EU Member
States;
 This applies to
◦ Authorized medicinal products for human or veterinary use placed on the
market and
◦ IMPs used in clinical trials.

 The system is based on two main pillars,
◦ The authorization/registration of operators in the supply
chain and
◦ Inspection of those operators
 To ensure compliance with
 legal requirements,
 GMP
 Requirements in the MA or CTA.

 Manufacturers and importers of medicinal products located in
the EU need to be authorized to carry out their activities.
 This obligation also applies to manufacturers and importers of
products only intended for export and IMPs.
 The C A of each Member State are responsible for granting the
authorizations
 A condition for grant of a manufacturing or import authorization
is that the manufacturers must comply with EU GMP.
10/17/2015 19

 GMP principles and guidelines are set out in two
Directives
◦ One for medicines for human use and
◦ The other for medicines for veterinary use.
 More detailed guidelines have been developed
through the work of the GMP and GDP Inspectors
Working Group
 see Link
10/17/2015 20

 Manufacturers and importers of medicinal products located in the European
Union or manufacturers located in a third country are regularly inspected by
an EU competent authority for compliance with EU GMP.
 The outcome of these inspections must be accepted by all other EU
authorities.
 After every inspection a GMP certificate (positive outcome) or noncompliance
report (negative outcome) must be issued by the inspecting authority
 This is entered in the Eudra GMDP database, which is accessible by
regulators in other countries.
 Most of this information is also available to the general public.
 See Link

 Inspections of manufacturers are typically requested in order to
 Grant or maintain a manufacturing or import authorization (EU sites)
or
 Assessment, approval and maintenance of an MA (typically sites
outside the EU) or CTA.
◦ For example, EMA may request that an EU competent authority undertake a
preapproval GMP inspection of a site included in a MA application through the
Centralized procedure or
◦ That an EU competent authority undertake periodic repeated post authorization
surveillance inspections of sites named in centralized MAs,
◦ In order to verify ongoing compliance with GMP and that the requirements of the MA
are being met.
10/17/2015 22

 According to EU legislation, the interval for
repeated GMP inspection should be based on risk.
 As a result, a procedure outlining a risk-based
model to frequency of inspections is included in
the Compilation of European Union Procedures on
Inspections and Exchange of Information
 See Link
10/17/2015 23

 Manufacturers, importers and distributors of active
substance located in the European Union are
required to comply with GMP
 Must be registered to the National Competent
Authority of the Member State where they are
located.
10/17/2015 24

 For active substances manufactured outside the EU and
imported:
◦ Each batch needs to be accompanied by a written confirmation
◦ This should be issued by the competent authority of the country
where it is produced
◦ W C should Confirm among other things, that GMP at least
equivalent to that in place in the European Union has been applied
to its manufacture.
◦ The C Aof the exporting country also needs to confirm that any GMP
noncompliance arising at the manufacturing site would be
communicated to the European Union.
 The receipt of this noncompliance information is via the EMA.

 The requirement for the written
confirmation can only be waived
◦ If the third country is included by the European
Commission, after assessment, in a list of countries with an
equivalent system of supervision and inspection or,
◦ Exceptionally, in order to ensure availability of medicines in
the EU market, if a GMP certificate for the site has been
issued by an EU competent authority after inspection.
10/17/2015 26

 The requirement for written confirmation, introduced from July 2013
by Directive 2011/62/EU requires that authorities outside of the EU
take responsibility for active substances manufactured in their
territory, if exported to the EU.
◦ See Link
 This requirement caused some debate before its implementation
 There were concerns on its potential to cause shortages in the EU, if
the exporting authorities were not willing or able to provide the
written confirmations,
 However this was not the case and countries gave a written
confirmation.
10/17/2015 27

 The EU legislation places the responsibility for using active
substances manufactured in compliance with GMP on
◦ The medicinal product manufacturer or
◦ The importer (in case the medicinal product is manufactured outside the European
Union).
 The holder of the MA or EU importer must
◦ Verify the registration status of the manufacturer of the active substance and
◦ verify compliance by the manufacturer of active substance with GMP,
 This should be done by conducting audits at the manufacturing site.
 This compliance can be implemented directly or with use a third
party acting under a contract.
10/17/2015 28

 Inspections of active substance manufacturers are carried out by EU
competent authorities following a risk-based approach, or if there is
suspicion of noncompliance.
 See Link
 Furthermore, every application for an MA must include a confirmation
that the holder of the MA has verified compliance of the manufacturer of
the active substance with principles and guidelines of GMP.
 The confirmation shall contain a reference to the date of the audit
 A declaration by the Qualified Person that the outcome of the audit
confirms that the manufacturing complies with GMP principles and
guidelines.
 See Link

 Inspections of active substance manufacturers may also be
organized by the European Directorate for the Quality of Medicines &
Healthcare (EDQM) of the Council of Europe, on behalf of the EU.
 See Link
 The Council of Europe has 47 members including all EU Member
States and it has close cooperation with the EU.
 EDQM is responsible for developing and maintaining the European
Pharmacopoeia.
10/17/2015 30

 EDQM issues Certificates of Suitability with the monographs of the
European Pharmacopoeia (CEP) that can replace most of the data
normally expected in EU MA dossiers for the active substance.
 See Link
 In order to issue and maintain these certificates, EDQM runs its own
inspection program of active substance manufacturers.
 Most of the inspections organized by the EDQM are carried out by
inspectors from EU inspectorates.
10/17/2015 31

 Inspections are carried out by inspectorates of Member States.
 In order to avoid duplication it is necessary to identify the Member
State responsible for supervision and inspection of any
manufacturing sites for the EU market.
 This is achieved through the identification of one or more
Supervisory Authority (SA);
 The SA is the NCA in the EU responsible for the GMP supervision of
the site, including granting the manufacturing or import
authorization and GMP inspection.
10/17/2015 32

 If the manufacturing site is in the EU, the SA is the NCA of the
Member State where the site is located.
 In cases where the manufacturing site is outside the EU, the SA is
the NCA of the Member State in which the importer of the product(s)
is located.
 Where products from a manufacturing site located in a country
outside the EU are imported in more than one Member State, there
may be more than one SA, which cooperate in the supervision of the
manufacturing site.
10/17/2015 33

 An important feature of the supervision system in place in Europe is
the role of Qualified Person (QP).
 In order to obtain an authorization, EU manufacturers and importers
must have at their disposal the services of at least one Qualified
Person
 The Qualified Person must
◦ Take responsibility for securing that each batch of medicinal product, manufactured
or imported, has been manufactured in accordance with EU GMP, and
◦ Must certify compliance with GMP and with the relevant MA(s).
◦ See Link
10/17/2015 34

 A batch may only be released by a manufacturer or importer for
distribution in the EU after certification by the QP.
 Member States are empowered to take administrative and
disciplinary measures against QPs if they have failed to fulfil their
obligations.
 Furthermore, imported batches need to undergo a full retest in the
EU to ensure the quality of the product in accordance with the MA
specification.
 There-testing requirement is waived if there is an operational
Mutual Recognition Agreement in place between the EU and the
exporting country.

 The discovery of serious GMP noncompliance may have implications
for the Member State, which carries out the inspection, and all
Member States.
 International authorities would also be involved if the active
substance or product be supplied to them.
 A mechanism that ensures a coordinated approach for protection of
public and/or animal health is taken throughout the European Union
.
 See Link

 Objective of this Procedure:
◦ Achieve a coordinated and harmonized assessment
◦ Proportionate supervisory actions
◦ Balance the protection of patients and minimize supply
disruptions
◦ Ensure maximum efficiency
◦ Avoid full parallel reviews on a national level across the
European Union.
10/17/2015 37

 European legislation provides that manufacturer
and import authorizations may be suspended or
not granted as a result of noncompliance with GMP.
 Also, existing MAs for the products affected can be
varied, not granted or revoked.
 Urgent measures include
◦ Prohibition of manufacture, importation or supply, and/or
◦ Withdrawal of all, or of specific batches from the market.
10/17/2015 38

 EUDRA GMDP is a publicly accessible Union database
◦ See Link
 A repository of
◦ Manufacturing and import authorizations,
◦ GMP certificates and
◦ Non-compliance reports.
 After every GMP inspection carried out by an EU competent
authority following information is entered in the database.
◦ A GMP certificate (positive outcome) or
◦ A noncompliance report (negative outcome)
10/17/2015 39

 The database includes a planning module (only accessible to the relevant
regulators) for coordination of inspections planned by EU authorities in countries
outside the European Union.
 Data are entered into the planning module in order to facilitate exchange of
information between competent authorities and reduce duplication and ensure the
best use of inspectional resources.
 EMA and EU authorities recognize the global nature of modern pharmaceutical
supply chains
 They also recognize the need for close collaboration and cooperation with
regulatory authorities outside the European Union
 Therefore work is ongoing to extend the use of the EudraGMDP database planning
module to include exchange of information on inspections planned by authorities
outside the European Union.
10/17/2015 40

 All the National inspectorates in the Member States should be
equivalent as regards the level of supervision they are able to
provide.
 A number of measures are put in place to ensure that this is
the case, summarized in subsequent slides

 Legislation
◦ The pharmaceutical legislation is developed at EU level.
◦ This is mainly in the form of Regulations and Directives.
◦ Both are applicable to all the Member States.
◦ Regulations are directly applicable to the entire EU territory.
◦ Directives have to be transposed into national legislation, in
a timeframe established in the Directive itself, usually 18
months.
10/17/2015 42

 Legislation
 The EU legal framework for medicinal products is intended to ensure
a high level of public health protection and to promote the
functioning of the EU internal market.
 The system is also designed to encourage innovation.
 It is a large body of legislation that ensures extensive harmonization
within the European Union, including GMP and inspections.
 The pharmaceutical legislation is published in the Official Journal of
the European Union.
◦ http://eur- lex.europa.eu/oj/direct-access.html
10/17/2015 43

 The EU GMP guide
 A single GMP guide is in use in the European Union.
 See Link
 The guide is referenced in the EU legislation
◦ Directives 2001/83/EC for human products,
◦ 2001/82/EC for veterinary products and in clinical trial legislation
◦ See Link
 This has long since replaced any previously existing national
GMP guide.
 The EU GMP guide provides the standards and requirements used
by EU inspectors for any GMP inspections
◦ Both in or outside of the European Union.
10/17/2015 44

 The EU GMP guide
 The guide is subdivided into tree parts and 19 annexes dealing
with specific types of manufacture.
 Part 1 is the GMP for finished products
 Part 2 GMP for active substances
 Part 3 includes GMP-related documents
 The EU GMP guide is harmonized with the PIC/S GMP guidelines
on an ongoing basis.
 EU GMP Part 2 reflects the EU’s agreement to the ICH Q7
guidelines and forms the basis of the detailed guidelines.
 The Compilation of European Union Procedures on Inspections
and Exchange of Information
10/17/2015 45

 The Compilation of European Union Procedures on Inspections and
Exchange of Information
 The Compilation of European Union Procedures on Inspections and
Exchange of Information (CoUPs) is a collection of procedures for
GMP and Good Distribution Practice (GDP).
◦ See Link
 This is applicable to all the inspectorates in the European Union.
 It provides a tool to facilitate cooperation between EU Member States
and a means to achieve harmonization.

 The Compilation of European Union Procedures on
Inspections and Exchange of Information
 The CoUP covers,
◦ The basis for national procedures that form part of the
national inspectorates’ quality systems,
◦ How quality defects and noncompliance are handled and
◦ How GMP and GDP inspections are carried out and
reported.
10/17/2015 47

 The Compilation of European Union Procedures on Inspections and Exchange of
Information
 The contents of the CoUP are constantly updated, developed and agreed,
 This is coordinated by EMA, by representatives of the Inspectorates of each Member
State, including those supervising the manufacture and import of veterinary medicinal
products only.
 Once agreed, they are adopted by the European Commission and then published on its
behalf by the EMA.
 Common Union formats for manufacturing and import authorizations, GMP certificates
and for statements of non-compliance with GMP have been agreed and published in the
compilation
 EU competent authorities have implemented them in order to enhance communication,
collaboration and cooperation between authorities.
 This common format enables Member States to enter manufacturing, importing and
distribution authorizations in the Union database, EudraGMDP
 See Link

 The GMP/GDP Inspectors Working Group
 The GMP/GDP Inspectors Working Group (GMDP IWG) is a group of
senior inspectors appointed by all the EEA competent authorities.
◦ SEE LINK
 They meet at EMA premises four times a year
 It is chaired by EMA
 A European Commission representative attends the meetings,
 Also observers from the European EDQM accession countries
(countries which have applied to be part of the EU but have not
joined yet) and MRA partners attend the meeting.
 Representatives from other international authorities can be invited
on a case-by-case basis
10/17/2015 49

 The GMP/GDP Inspections Working Group
 The group is a forum for harmonization and discussion of common
issues which are taken by the inspectors back to their NCA for
implementation.
 Any new or amended text of the EU GMP guide is developed by this
group, with the European Commission responsible for the final
adoption.
 The GMDP IWG also maintains the CoUP and oversees, on behalf of
the Heads of Medicines Agencies (HMAs) the Joint Audit Programme.
10/17/2015 50

 Training
 The GMDP IWG organises training for EEA inspectors and inspectors
from accession countries, aimed at raising the technical capability of
the inspectors,
 This ensures common understanding of issues related to GMP and
harmonization.
 In addition, EMA has signed a partnership agreement with PIC/S on
cooperation on training for GMP inspectors, which recognizes the
role that PIC/S plays in this area and avoids duplication of effort.
 See Link
10/17/2015 51

 Ensuring Equivalence before Joining the EU
 Becoming a member of the European Union is a complex procedure
 There are strict conditions for EU membership to ensure that new
members are admitted only when they are fully able to take on the
obligations of membership,
 This includes compliance with all the EU’s standards and rules.
 For the purpose of accession negotiations, these are divided into 35
different policy fields (chapters). Link
 For acceding to the EU, a candidate country must implement the EU rules
and regulations in all areas.
 The length of the membership negotiations can vary and depends on the
time needed to complete the necessary reforms and the alignment with
EU law.
 The candidates are supported financially, administratively and
technically during this pre-accession period.
10/17/2015 52

 Ensuring Equivalence before Joining the EU
 In order to ensure that new Member States joining the European
Union have reached the same level as the other members before the
date of accession, a number of measures are put in place. These
include:
◦ The European Commission checks compliance with the EU legislation (including
pharmaceutical legislation)
◦ Through the TAIEX program (Link) financed by the European Commission, technical
support may be provided
◦ Accession countries are invited as observers to EU meetings (including the GMDP IWG)
◦ Specific training on EU procedures is organized
10/17/2015 53

 Auditing is an important part of the measures put in place in order to
oversee the equivalence of Member States.
 There are a number of contexts in which Member States NCAs and/or
inspectorates can be audited.
 The Joint Audit Program (JAP) of the EU NCAs’ GMP inspectorates is an
internal audit program under the Heads of Medicines Agencies (HMA)
◦ Link
 This is run on behalf of HMA by the GMDP IWG.
 JAP aims at achieving and maintaining equivalence between Member
States’ national inspectorates responsible for GMP.
 It was established in October 2000 and is an important part of the
quality system adopted by all GMP inspectorates in the EU.
10/17/2015 54

 JAP auditors are senior GMP inspectors, further qualified for auditing
inspectorates through specific training.
 A list of qualified JAP auditors is maintained by the Compliance Group,
which is a subgroup of the GMDP IWG.
 Link
 JAP auditors also provide technical advice and support to accession
countries before they become EU Member States.
 EU inspectorates are audited through the JAP onsite, at intervals
established through a risk-based approach (typically every five to six
years).
 Mutual Recognition Agreement and other international partners are
invited on a case-by-case basis to join JAP audits of EU Member States
inspectorates as observers.
10/17/2015 55

 Audits are also organized in the framework of the Pharmaceutical
Inspection Convention and Pharmaceutical Inspection Co-operation
Scheme ,jointly referred to as PIC/S and Mutual Recognition
Agreement (MRA
 See Link
 Since most of the EU authorities and all MRA partners are member of
PIC/S, synergies between the various audit schemes are used in
order to avoid duplication.
10/17/2015 56

 The Benchmarking of European Medicines Agencies
 See Link
 (BEMA) is an internal EU program managed by the Heads of Medicines
Agencies,
 This is based on assessment of the systems and processes in individual
agencies against a set of indicators in four main areas:
◦ Management systems
◦ Assessment of marketing authorization applications
◦ Pharmacovigilance (drug safety) activities
◦ Inspection services
 The assessment identifies strengths and best practices in agencies and
any opportunity for improvement.
 The program has concluded its third cycle in 2015.
10/17/2015 57

 The European Union and its Member States are involved in several
bilateral and multilateral cooperation activities with international
partners in the GMP area.
 The main advantage is that international cooperation allows, by
relying on information received from trusted international
authorities, to reallocate foreign inspections towards areas more at
risk.
 It thus optimizes available inspection resources.
10/17/2015 58

 PIC/S
 Pharmaceutical Inspection Convention and Pharmaceutical Inspection
Co-operation Scheme
 Jointly referred to as PIC/S
 http://www.picscheme.org/pics.php
 Aims at harmonizing inspection procedures worldwide
 Develops common standards in the field of GMP
 Provides training opportunities to inspectors.
 Facilitates cooperation and networking between competent authorities,
regional and international organizations.
 Most EU Member States are members of PIC/S while EMA is participating
10/17/2015 59

 Mutual Recognition Agreements ( MRA’s)
 Link
 Official agreements on the mutual recognition of assessment of
conformity of regulated products, which are negotiated and signed at EU
level.
 MRAs concluded by the European Union include pharmaceuticals and
cover GMP.
 Consequently, inspection results carried out by MRA partners in their
territory are recognized by EU Member States and vice versa
 Retesting upon importation into the European Union is not needed in the
QP batch certification process.
 The MRA scope can cover both human and veterinary products, finished
products, active substances and Investigational Medicinal Products.
10/17/2015 60

 There are differences in scope between the various MRAs.
 Currently, the European Union has operational MRAs in place with Australia,
Canada, Japan, New Zealand and Switzerland.
 The EU also has in place an Agreement on Conformity Assessment and
Acceptance of industrial products (ACAA), which includes GMP, with Israel.
 An ACAA is a specific type of MRA;
 The main practical difference is that in the ACAA case results of inspections
carried out outside the territory of the agreement partners are mutually
recognized as well, in addition to inspections carried out in the partners’
territory.
 An MRA between the European Union and the United States was signed in
1999; at the time of this writing it is operational only toward rapid alerts.
10/17/2015 61

 International Coalition of Medicines Regulatory Authorities (ICMRA).
 Link
 The European Commission, EMA and some EU Member States participate to the
activities of the International Coalition of Medicines Regulatory Authorities
◦ (France, Germany, Ireland, Italy, Spain and UK)
 Recent initiative
 Started by Heads of Medicines Agencies worldwide,
 Aims at providing global strategic coordination and direction on areas that are
common to many regulatory authorities’ missions worldwide,
 Builds on existing arrangements such as those of PIC/S.
 The ICMRA has the objective to establish synergies and to foster global
cooperation among regulators and GMP is one of the ICMRA main areas of
interest.
10/17/2015 62

 Other International Cooperation Activities
 In addition to MRAs, the European Union is involved in several less
formalized cooperation schemes on GMP with international partners and/or
in areas not covered by an MRA
 API international cooperation project
 Main objectives are the sharing of information on inspection planning, policy
and inspection reports and joint inspections on manufacturers located
outside the participating countries.
 It includes the following participants:
 The EMA and all EU member States, the European EDQM, the U.S. FDA, the
Australian Therapeutic Goods Administration (TGA) and WHO.
10/17/2015 63

 Several bilateral pilots and programs between EMA and FDA were also developed
during the last ten years with the view to increase collaboration on domestic and
third country GMP inspections.
 This less formal form of cooperation in the last years has allowed the building of
confidence among cooperating countries and regions, mainly through joint
inspections and exchange of information
 Link
 It is opening new possibilities of mutual reliance on inspection results.
 In this perspective, it is worth noting that the European Union has identified the
recognition of GMP inspections carried out in the European Union and the United
States and in third countries as a main objective for the pharmaceutical sector in
the context of the negotiations of the Transatlantic Trade and Investment
Partnership
 Link
10/17/2015 64

This presentation is compiled from freely available
resource like the website of EMA & EU.
“Drug Regulations” is a non profit organization
which provides free online resource to the
Pharmaceutical Professional.
10/17/2015 65
Drug Regulations : Online
Resource for Latest Information

Presentation on EU Regulatory & Quality System.

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Presentation on EU Regulatory & Quality System.