The European Medicines Agency (EMA) regulates medicines for both human and veterinary use across Europe. Key responsibilities of EMA include evaluating applications for new medicines and monitoring approved medicines. EMA operates through various scientific committees and follows regulatory procedures for clinical trials and marketing authorization applications. EMA helps ensure that medicines available across Europe are safe, effective and of high quality.

1. DATCHAYANI.B
M.PHARM -I
Pharmaceutical
Regulatory Affairs

2.  INTRODUCTION
 HISTORY OF EMA
 MILESTONES AND ACHEIVEMENTS
 MISSION OF EMA
 WHAT THEY REGULATE
 WHAT THEY DON’T REGULATE
 HOW THEY WORK
 ORGANISATION OF EMA
 EDQM
 EUDRALEX
 SCIENTIFIC COMMITTEES OF EMA
 DRUG APPROVAL PROCEDURES WITH FEES PAYABLE
 BIOSIMILARS
 ASMF
 EU-CTD

4.  The European Medicines Agency (EMA) is a decentralised agency of
the European Union (EU).
 The Management Board is the European Medicines Agency's integral
governance body.
 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 27 EU Member States, as well
as the countries of the European Economic Area, by ensuring that all
medicines available on the EU market are safe, effective and of high
quality.
 EMA serves a market of over 500 million people living in the EU.

5.  European medical agency was founded in 1995 , has worked
across the European Union (EU) and globally to protect public and
animal health by assessing medicines to rigorous scientific
standards and by providing partners and stakeholders with
independent, science-based information on medicines
 EMA has a 20-year track record of ensuring efficacy and safety
of human and veterinary medicines across Europe, and promoting
research and innovation in the development of medicines.
 In its first two decades, the Agency recommended the
authorisation of a total of 975 human and 188 veterinary
medicines.

6. EMA was set up in 1995 to harmonise the work of existing national
medicine regulatory bodies.
20TH ANNIVERSARY OF EMA:-
2015 marked the 20th anniversary of EMA. The Agency produced a
20th anniversary book, which captures the important progress in
regulatory science and changes in medicines regulation in the first
20 years,
50 YEARS OF PHARMACEUTICAL LEGISLATION
2015 also marked the 50th anniversary of the introduction of the
first EU legislation on human medicines.
EUROPEAN MEDICAL AGENCY GROWTH CHART

7. The mission of the European
Medicines Agency (EMA) is to
foster scientific excellence in the
evaluation and supervision of
medicines, for the benefit of public
and animal health in the European
Union (EU).

8. A strapline is incorporated in the EMA
logo to represent the three pillars on
which all of the EMA's work is based:-
SCIENCE, representing the scientific
expertise that guides the EMA in all of its
regulatory decision-making.
MEDICINES, representing the EMA's
focus on assessing and monitoring
medicines to ensure their quality, safety
and efficacy.
HEALTH, representing the purpose for
which the Agency was created, namely to
protect and improve public and animal
health.

10. • EMA is committed to enabling timely
patient access to new medicines,
and plays a vital role in supporting
medicine development for the benefit
of patients.
Facilitate
development and
access to medicines
• EMA continuously monitors and
supervises the safety of medicines
that have been authorised in the EU,
to ensure that their benefits
outweigh their risks.
Monitor the safety of
medicines across
their lifecycle
• The Agency publishes clear and
impartial information about
medicines and their approved uses.
This includes public versions of
scientific assessment reports and
summaries written in lay language.
Provide information
to healthcare
professionals and
patients

11. • The vast majority of medicines available in the
EU are authorised at national level, either
because they were authorised before EMA’s
creation or they were not in the scope of the
centralised procedure the Agency is responsible
for.
Evaluate the initial
marketing
authorisation
application of all
medicines in the EU.
• The authorisation of clinical trials occurs at
Member State level,
Evaluate
applications for the
authorisation of
clinical trials.
• EMA does not operate laboratories on its
premises or elsewhere, and is not involved in
conducting clinical trials.
Carry out research
or develop
medicines.

12. • Once a marketing authorisation has
been granted, decisions about price and
reimbursement take place at the level of
each Member State
Take decisions on
the price or
availability of
medicines.
• National governments or the health
authorities of individual EU Member
States develop guidelines for decisions
regarding diagnosis, management, and
treatment in specific areas of healthcare
Develop treatment
guidelines
• The legal decision to grant, suspend or
revoke a marketing authorisation for any
medicine falls under the remit of the
European Commission for centrally
authorised products, and the national
competent authorities of the EU Member
States for nationally authorised products.
Issue of marketing
authorisations.

13. The European
Medicines Agency
(EMA) works closely
with national
competent authorities
in a regulatory
network.
The Agency also
implements policies
and procedures to
ensure it works
independently, openly
and transparently.
Upholds the highest
standards in its
scientific
recommendations.
EMA

14. ORGANISATION CHART
ADMINISTRATION AND CORPORATE MANAGEMENT AND DIVISION
HUMAN MEDICINES RESEARCH & DEVELOPMENT SUPPORT DIVISION
HUMAN MEDICINES EVALUATION DIVISION
INFORMATION MANAGEMENT DIVISION
STAKEHOLDERS & COMMUNICATION DIVISION
VETERINARY MEDICINES DIVISION
INSPECTIONS, HUMAN MEDICINES PHARMACOVIGILANCE AND
COMMITTEES DIVISION

15.  The EDQM (EUROPEAN DIRECTORATE FOR QUALITY
MEDICINES)is an organisation that protects public health by
enabling the development, supporting the implementation and
monitoring the application of quality standards for medicines and
their safe use.
 The EDQM traces its origins and statutes to a European treaty
promoting the elaboration of a common pharmacopoeia in Europe.
 MISSION: to contribute to a basic human right; access to good
quality medicines and healthcare .
STRUCTURE OF EDQM

16.  EUDRALEX stands for European Union drug Legislation Medicinal
Products for Human Use.
 EudraLex is the collection of rules and regulations governing
medicinal products in the European Union.
 EudraLex consists of 10 volumes:
Concerning Medicinal Products for Human use:
1. Volume 1 - Pharmaceutical Legislation.
2.Volume 2 - Notice to Applicants.
a. Volume 2A deals with procedures for marketing
authorization.
b. Volume 2B deals with the presentation and content of the
application dossier.
c. Volume 2C deals with Guidelines.

17. 3. Volume 3 - Guidelines.
 Concerning Medicinal Products for human use in clinical trials
(investigational medicinal products).
4. Volume 4 - Good Manufacturing Practices.
5. Volume 9 - Pharmacovigilance.
 Concerning Veterinary Medicinal Products:
6. Volume 5 - Pharmaceutical Legislation.
7. Volume 6 - Notice to Applicants.
8. Volume 7 - Guidelines.
9. Volume 8 - Maximum residue limits.
 Concerning Medicinal Products for human use in clinical
trials (investigational medicinal products).
10. volume 10 - Clinical trials.

18. EMA consist of 7 scientific committees :-
 Committee for Medicinal Products for Human Use (CHMP)
 Pharmacovigilance Risk Assessment Committee (PRAC)
 Committee for Medicinal Products for Veterinary Use (CVMP)
 Committee for Orphan Medicinal Products (COMP)
 Committee on Herbal Medicinal Products (HMPC)
 Committee for Advanced Therapies (CAT)
 Paediatric Committee (PDCO)

19. The Committee for Medicinal Products for Human Use (CHMP) is
responsible for preparing the Agency's opinions on all questions
concerning medicines for human use, in accordance with Regulation
(EC) No 726/2004.
ROLE OF CHMP:- The CHMP plays a vital role in the marketing
procedures for medicines in the European Union :-
centralised procedure:- The CHMP is responsible for:-
 conducting the initial assessment of medicines for which an EU-wide
marketing authorisation is sought.
 post-authorisation and maintenance activities, including the assessment
of any modifications or extensions (‘variations’) to an existing marketing
authorisation.

20. In case of MUTUAL-RECOGNITION PROCEDURE:-
 The CHMP arbitrates in cases where there is a disagreement
between Member States concerning the marketing authorisation of a
particular medicine .
OTHER IMPORTANT ROLES OF CHMP:-
 The CHMP publishes a European public assessment report (EPAR)
for every centrally authorised medicine that is granted a marketing
authorisation.
 It provides provision of assistance to companies researching and
developing new medicines;
 The preparation of scientific and regulatory guidelines for the
pharmaceuticals industry;
 Cooperation with international partners on the harmonisation of
regulatory requirements for medicines.

21. The Pharmacovigilance Risk Assessment Committee (PRAC) is
responsible for assessing and monitoring safety issues for human
medicines. This includes the detection, assessment, minimisation
and communication relating to the risk of adverse reactions, while
taking the therapeutic effect of the medicine into account.
ROLE OF PRAC:-
 It has responsibility for the design and evaluation of post-
authorisation safety studies and Pharmacovigilance audit.
 The main responsibility of the PRAC is to prepare recommendations
on any questions relating to Pharmacovigilance activities related to
a medicine for human use.

22. The Committee for Medicinal Products for Veterinary Use
(CVMP) is responsible for preparing opinions on questions
concerning medicines for veterinary use.
ROLE OF CVMP:-
 A core activity of the CVMP is the establishment of MRLs: the
'maximum residue limits' of veterinary medicines permissible in food
produced by or from animals for human consumption, including dairy
products, meat, honey etc.

23. The Committee for Orphan Medicinal Products (COMP) is
responsible for reviewing applications from people or companies
seeking 'orphan-medicinal-product designation' for products they
intend to develop for the diagnosis, prevention or treatment of life-
threatening or very serious conditions that affect not more than 5 in
10,000 persons in the European Union.
ROLE OF COMP:-
 The COMP is responsible for advising the European Commission on
the establishment and development of a policy on orphan medicinal
products in the EU,
 Assists the Commission in drawing up detailed guidelines and
liaising internationally on matters relating to orphan medicinal
products.

24.  The Committee on Herbal Medicinal Products (HMPC) is the
committee at the European Medicines Agency that is responsible for
preparing the Agency's opinions on herbal medicines.
 The Committee was established in accordance with Regulation
(EC) No 726/2004 and Directive 2004/24/EC, which introduced a
simplified registration procedure for traditional herbal medicinal
products in EU Member States.
ROLE OF HPMC:-
 The HMPC's activities aim at assisting the harmonisation of
procedures and provisions concerning herbal medicinal products
laid down in EU Member States, and further integrating herbal
medicinal products in the European regulatory framework.

25.  The Committee for Advanced Therapies (CAT) is responsible for
assessing the quality, safety and efficacy of advanced-therapy
medicinal products (ATMPs) and following scientific developments in
the field.
 It was established in accordance with Regulation (EC) No
1394/2007 on ATMPs.
ROLE OF CAT :-
 The main responsibility of the CAT is to prepare a draft opinion on
each ATMP application submitted to the European Medicines
Agency, before the CHMP adopts a final opinion on the granting,
variation, suspension or revocation of a marketing authorisation for
the medicine concerned.

26. The Paediatric Committee (PDCO) is responsible for assessing
the content of paediatric investigation plans and adopting opinions
on them. This includes assessing applications for full or partial
waivers and assessing applications for deferrals.
The PDCO was established in accordance with the Paediatric
Regulation (Regulation (EC) 1901/2006 as amended).
ROLE OF PDCO:-
 assessing data generated in accordance with agreed PIPs;
 providing advice on questions on paediatric medicines, at the
request of the Agency's Executive Director or the European
Commission;
 advising the Agency and the European Commission on the
communication of arrangements available for conducting research
into paediatric medicines.

27. EXECUTIVE DIRECTOR
Guido Rasi.
DEPUTY EXECUTIVE
DIRECTOR
Mr Noël Wathion.
HEAD OF SCIENTIFIC
COMMITTEES
REGULATORY
SCIENCE STRATEGY
Anthony Humphreys
EU MEMBER STATES

28.  There are two regulatory steps to go through before a drug is
approved to be marketed in the European union.
 These two steps are:-
Clinical trial application
Marketing authorization application.
 Clinical trial applications are approved at the Member State level.
 Marketing authorization applications are approved at both the
Member State or centralized levels.

29. CLINICAL TRIAL APPLICATION:-
 EU Directive 2001/20/EC (April 2001) sets out the new rules and
regulations for the approval and conduct of clinical trials in Europe.
 A sponsor submits a clinical trial application to the Competent
Authority in each Member State where the trials are to be
conducted.
 The Competent Authority has 60 days to review and approve or
reject the application.
 Application is in prescribed forms and covers the proposed clinical
trial protocol, manufacturing and quality controls on the drug, and
supporting data, such as ,
(a) chemical, pharmaceutical and biological data,
(b) non- clinical pharmacological and toxicological data,
(c) clinical data and previous human experience.

30.  The supporting data are submitted in the Common Technical
Document (CTD) format.
 Qualified Person has to certify that the investigational medicinal
product (IMP) is manufactured according to GMP.
 The Competent Authority has the right to inspect the manufacturing
facility for GMP compliance, the preclinical facility for GLP
compliance, and the clinical trial sites for GCP compliance.
CLINICAL TRIAL APPLICATION APPROVAL PROCESS

31.  The Investigational Medicinal Product Dossier is the basis for
approval of clinical trials by the competent authorities in the EU.
 The Clinical Trials Directive (2001/20/EC) came into force in April
2001, harmonizing the laws, regulations and administrative
provisions of the Member States relating to the implementation of
Good Clinical Practice (GCP) in the conduct of clinical trials on
medicinal products for human use.
 The Directive introduced a harmonized procedure for the
authorisation to perform a clinical study in any one of the EU
Member States.
 In addition, it defines the documentation to be submitted to the
Ethics Committee as well as the Investigational Medicinal Product
Dossier (IMPD) to be submitted to the competent authority for
approval.

32. MARKETING AUTHORIZATION:-
 Following successful clinical trials, the sponsor has to apply for
authorization to market the drug in Europe.
 Depending on the type of drug product and the intended market, there
are. four different types of marketing authorization applications. They
are:-
1. Centralised procedure.
2. Mutual recognition procedure.
3. National authorization procedure.
4. Decentralised procedure.

33. Class Details Legal Type
Full dossier Has to contain the complete data set –
CTD Module 1-5 Article 8
Generic Pure generic application Article 10 (1)
Biosimilar Generic Biotech products Article 10 (4)
Bibliographic application,
WEU (Well Established
Use)
Non-clinical & Clinical Data replaced by –
literature - 10 years systematic and
documented use of the substance as a
medicinal product in the EU
Article 10a
Fixed dose combination
applications
pre-clinical data and clinical data for the
combination
Article 10b
Informed consent Innovator’s generic product. (Duplicate
dossier)
Article 10c

34. LARGE MOLECULE-
PROTEIN BASED DRUG
CENTRALIZED
PROCEDURE
SMALL MOLECULE
SYNTHETIC DRUG
NATIONAL
AUTHORIZATION
PROCEDURE
MUTUAL RECOGNITION
PROCEDURE
GENERICS
ABRIDGED NATIONAL
AUTHORISATION
PROCEDURE

36. CENTRALISED PROCEDURE:
PREPARATION OF MARKETING AUTHORIZATION APPLICATION
DOSSIER :
 The application dossier is divided into four parts:
 Part I: Summary of the dossier
 Part II: Chemical/pharmaceutical/biological documentation
 Part III: Toxico-Pharmaceutical documentation
 Part IV: Clinical documentation.

37.  The Mutual Recognition Procedure is stated in Council Directive
93/39/EEC.
 In essence, once a drug is approved for marketing authorization by
one Member State, it is eligible to apply for marketing authorization
in other Member States through the mutual recognition procedure in
place since 1998.
 Identical applications are submitted to those Member States where
marketing authorizations are sought.
 The first Member State that reviews the application is called the
’Reference Member State’. It notifies other states, called ‘Concerned
Member States’.

38.  Concerned Member States may suspend their own evaluations to
await assessment by the Reference Member State.
 The decision of the Reference Member State is forwarded to the
Concerned Member States.
 If the Concerned Member States reject mutual recognition, the
matter is referred to the CHMP of the EMA for arbitration.
 The EMA forwards its opinion to the European Commission, which
makes the final decision. Altogether, the decision process may take
up to 300 days if there is no objection, and 600 days when
objections are raised.
MUTUAL RECOGNITION PROCESS

39.  This procedure is used whenever a company wants to
commercialize a product in only one EU Member State.
 The National procedure is specific to each country. That is, each
country within the EU has its own procedures for authorizing a
marketing application for a new drug.
 Sponsors can find information regarding the requirements and
procedure of each country on the websites of the regulatory
agencies.
 To obtain marketing authorization in a country, the application must
be submitted to the Competent Authority of that Member State in its
own language.

40.  The objective of this procedure is to obtain marketing authorizations in
several Member States, when no marketing authorization has been
granted in the European Community.
 The applicant should send an application to the competent authorities
of each of the Member States, where there is intent to obtain a
marketing authorization.
 The applicant may designate a country to act as the Reference
Member State (RMS).
 The RMS will start the procedure after the application is determined to
be complete by both the RMS and all the CMS(s).
 The RMS forwards a preliminary Assessment Report on the dossier to
the CMS(s) and the applicant within 70 days.

41.  The CMS(s) is asked to give comments on the proposed national
prescription status and to inform the RMS.
 On day 105, the RMS will forward all comments to the applicant and
stops the clock if necessary, until the applicant prepares a response
document.
 The RMS prepares a Draft Assessment Report on day 120 and may
close the procedure if a consensus has been reached between the
CMS(s) and the RMS.
 Otherwise, the CMS(s) has 90 more days to approve the Draft
Assessment Report, and other documents.
 Competent authorities of the RMS and the CMS(s) adopt a decision
within 30 days after acknowledgement of their agreement to the
Assessment Report and other documents.
 At the end of the Decentralized Procedure with a positive agreement, a
national marketing authorization will be issued in the RMS and each of
the CMS(s).

43. Fee type Human medicines Veterinary medicines
Marketing-
authorisation
application (single
strength, one
pharmaceutical form,
one presentation)
From €278,800 From €139,600
Extension of
marketing
authorisation (level I)
€83,700 €34,900
Type-II variation
(major variation)
€83,700 €41,800
Scientific advice From €41,800 to €83,700 From €13,800 to 41,800
Annual fee (level I) €100,000 €33,400

44.  Orphan Drug: EU Regulation on orphan medicinal products EC
141/2000 and EC 847/2000 apply for products intended for
treatment of rare diseases.
 If a medical condition does not affect more than 5 in 10,000 persons
in the Community an orphan designation may be applied for.
 Prove of the prevalence of a rare condition should follow
COMP/436/01.
 The designation procedure with the COMP takes 90 days plus 30
days for Commission approval.
 Additionally, the sponsor has to file an application for a marketing
authorisation through the centralised procedure and only after
approval may bring the orphan drug product on the EU market.
 The approval includes a 10 years exclusive marketing right.

46.  The Herbal Directive (Directive 2004/24/EC) was adopted to
facilitate the placing on the EU market of traditional herbal medicinal
products.
 In particular, herbal products marketed in the form of food
supplements should comply with Directive 2002/46/EC on food
supplements and Regulation (EC) No 1924/2006 on nutrition and
health claims made on foods.
SIMPLIFIED PROCEDURE:-
 The simplified procedure allows the registration of traditional herbal
medicinal products, including Chinese or Ayurvedic herbal
medicinal products or herbal medicinal products from any other
tradition, without requiring tests and trials on safety and efficacy,
which the applicant is normally obliged to provide.
 Instead for registration of traditional herbal medicinal products, the
applicant has to only provide sufficient evidence of the medicinal
use of the product throughout a period of at least 30 years, including
at least 15 years in the European Union.

47.  A biosimilar medicine is a biological medicine that is developed to
be similar to an existing biological medicine (the ‘reference
medicine),
EVALUATION OF BIOSIMILARS IN EU:-
 The main part of the evaluation is a comparison of the biosimilar
with its reference medicine to show that there are no significant
differences between them.
WHAT THEY WILL COMPARE????
 The relevant regulatory authority applies stringent criteria in their
evaluation of the studies comparing the quality, safety and
effectiveness of the two medicines.

48. comprehensive comparisons of the
structure and biological activity of
their active substances
will check for any significant
differences in their
benefits and risks, including the risk of
immune reactions.
Effectiveness of the drug

49.  Certificates of Suitability to the Monographs of the European
Pharmacopoeia (CEP) are granted by the Certification Secretariat of
the European Directorate for the Quality of Medicine.
 CEP can be used by the manufacturers of pharmaceutical products
in their applications for marketing authorization to demonstrate the
compliance of the substance with the monographs of the European
Pharmacopoeia and Directives 2001/83/EC and 2001/82/EC.
 By means of a CEP, an API manufacturer will be able to provide
proof that the quality of a substance is suitably controlled by the
relevant monographs of the European Pharmacopoeia, and whether
it can be used in medicinal products.

50.  Regardless of where they are conducted, all clinical trials included in
applications for marketing authorisation for human medicines in the
European Economic Area must have been carried out in accordance
with the requirements set out in Annex 1 of Directive 2001/83/EC.
 This means that:
1. clinical trials conducted in the EEA have to comply with European
Union (EU) clinical-trial legislation (Directive 2001/20/EC);
2. clinical trials conducted outside the EEA have to comply with
ethical principles equivalent to those set out in the EEA, including
adhering to international good clinical practice and the Declaration
of Helsinki.

51.  The European Medicines Agency is responsible for coordinating
inspections to verify compliance with the principles of good
manufacturing practice (GMP), good clinical practice (GCP), good
laboratory practice (GLP) and good pharmacovigilance practice
(GVP).
 Inspections also verify compliance with other aspects of the
supervision of authorised medicinal products in use in the European
Union.
 These are described in Regulation (EC) 726/2004, in Directive
2001/83/EC and in Directive 2001/82/EC.
Sampling and testing:-
 The Agency also implements a sampling and testing programme
aimed at supervising the quality of centrally authorised medicines
available on the European market.

52.  Active Substance Master File (ASMF) is otherwise known as
European drug master file(EDMF).
OBJECTIVE:-
 The main objective of the Active Substance Master File
(ASMF) procedure, is to allow valuable confidential intellectual
property or 'know-how' of the manufacturer of the active substance
(ASM) to be protected.
 while at the same time allowing the Applicant or Marketing
Authorisation (MA) holder to take full responsibility for the medicinal
product and the quality and quality control of the active substance.
 ASMFs linked to human and veterinary medicinal products should
be presented in the format of the Common Technical Document
(CTD).

53. SCIENTIFIC INFORMATION IN THE ASMF:
 The scientific information in the ASMF should be physically divided
into two separate parts, namely:-
1. APPLICANT’S PART (AP):
The AP contains the information that the ASMF holder regards as
non-confidential to the Applicant/MA holder.
2. RESTRICTED PART (RP):
RP contains the information that the ASMF holder regards as confidential.
 ASMF can only be submitted in support of an MAA or MAV
 The ASMF holder should submit the ASMF to the National
Competent Authority/EMA either for each MAA and each MAV or
only once according to national requirements.

54.  The European union Common Technical Document (EU-CTD)
describes the organisation of modules, sections and documents to
be used by an Applicant for a Marketing Authorisation for a
medicinal product for human use in the European Union,
 European adopted CTD submission since 2003.
eCTD IN THE CENTRALISED PROCEDURE:
 In centralised procedure the EMA now only accepts submissions
received in eCTD format.
 Since January 2013 and "Mandatory from March 2014" all eCTD
submissions must be sent using the dedicated submission channels:
eSubmission Gateway or the related eSubmission Web Client

55. eCTD IN THE MUTUAL RECOGNITION /DECENTRALISED
PROCEDURE:-
To facilitate the use of eCTD as the highly recommended
submission format in the MRP and DCP, a Best Practice Guide is
published by the CMDh

56.  Intas Biopharmaceuticals Limited a mid-sized generic formulation
manufacturer located in Ahmedabad, India.
 The company faced EU-GMP (Good Manufacturing Practice) audit
in December 2006, to seek approval of clinical trial of its biosimilar
Filgrastim in Europe and was certified as EU-GMP compliant in April
2007, becoming the first company in India to receive such
certification for biologics facility.
 Accofil also received marketing authorisation in the European
union.

57. DRUG NAME ACTIVE
INGREDIENT
THERAPEUT
IC AREA
DATE OF
AUTHORISATIO
N
MARKETING
AUTHORISATIO
N HOLDER
Truberzi Eluxadoline Irritable
Bowel
Syndrome,
Diarrhoea
19/09/2016 Aptalis Pharma
SAS
Cabometyx cabozantinib
s-malate
Carcinoma,
Renal Cell
09/9/2016 Ipsen Pharma
Nordimet Methotrexate Rheumatoid
Arthritis,
juvenile
Arthritis
18/08/2016 Nordic Group B.V.
Airexar
Spiromax
salmeterol /
fluticasone
propionate
Asthma,
COPD
18/08/2016 Teva B.V
NEWLY AUTHORISED DRUGS:

58. DRUG NAME ACTIVE
INGREDIENT
THERAPEUTI
C AREA
DATE OF
ADOPTING
POSITIVE
OPINION
APPLICANT
Ocaliva obeticholic
acid
Liver Cirrhosis 13/10/2016 Intercept
pharma ,ltd
Rekovelle follitropin
delta
intended for
controlled
ovarian
stimulation in
women
undergoing
assisted
reproductive
technologies
(ART).
13/10/2016 . Ferring
Pharmaceutic
als A/S
HUMAN DRUGS WHICH RECEIVED POSITIVE OPINION FROM CHMP:-

59. DRUG NAME ACTIVE
INGREDIENT
THERAPEUTIC
AREA
DATE OF
ADOPTING
POSITIVE
OPINION
APPLICANT
Halagon halofuginone It is used to
prevent diarrhoea
in new born calve
06/10/2016 Emdoka BVBA
Cepedex dexmedetomid
ine
hydrochloride
Intended for
sedation and
analgesia in dogs.
06/10/2016 CP-Pharma
Handelsgesells
chaft mbH
VarroMed oxalic acid
dihydrate /
formic acid
treatment of
Varroa-mite
infestation
06/10/2016 BeeVital
GmbH
VETERINARY DRUGS WHICH RECEIVED POSITIVE OPINION FROM
CHMP:-

60. GUIDELINES THAT ARE RECENTLY UPDATED:
DATE OF RELEASE OR
ADDITION
GUIDELINES
15/08/2016 Better monitoring of biological medicines
New chapter in guidelines on good
pharmacovigilance practices
11/08/2016 Data integrity: key to public health protection
New guidance now available on EMA’s website

61. Office address
European Medicines Agency
30 Churchill Place
Canary Wharf
London E14 5EU
United Kingdom
Tel. +44 (0)20 3660 6000
Fax: +44 (0)20 3660 5555

62.  www.ema.europa.eu/
 Review article by Santosh Kumar Narla “MARKETING
AUTHORIZATION OF HUMAN MEDICINAL PRODUCTS TO
EUROPEAN UNION/EUROPEAN ECONOMIC AREA “. Volume 10,
Issue 1, September – October 2011; Article-001.
 Review article by K. P. R. Chowdary*, K. Ravi Shankar and G.
Saranya “A COMPARATIVE STUDY OF DRUG APPROVAL
PROCESS IN UNITED STATES, EUROPE AND INDIA “. Volume 4,
Issue 7, 419-427.
 Life science Technical bulletin by arash ghaLamkarPour
“MARKETING AUTHORIZATION PROCEDURES IN THE
EUROPEAN UNION – MAKING THE RIGHT CHOICE”. issue n°33
/december 2009.