Rak presentation

Regulatory Environment in the Middle East
opportunities & challenges
Mamoona Firdous Naqvi
Dec16,2015
RAK Medical & Health sciences University
RAK College of Pharmaceutical Sciences

Discussion points
What is Regulatory Affairs and why it is needed
Approval pathway of new / Generic drug
Regulatory environment in major markets of the
Middle East
Harmonization Initiatives in the region
1
5
Julphar6 2
Opportunities and Challenges
2
3
4

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What is Regulatory Affairs?
Regulatory Affairs:
It is a unique mix of science and management to
full fill medical need of patients and achieve
a commercially important goal within a
drug-development organization.
Touches everything relating to drugs from the earliest non-
clinical studies, through development, into routine manufacture,
registration of product , marketing and post marketing surveillance

Regulatory Affairs
5

Regulatory
Affairs
Medical
Business
Developmen
t
Finance
PRODUCT
DEVELOPMENT
MARKETINGSALE
QUALITY
CONTROL
QUALITY
ASSURANCE
SUPPLY
CHAIN AND
PROCURME
NT
Medical Indication s, Labeling
&packaging , pharmaco-vigilance
Build pipeline , fast track
registration , early entry in
the market
Price
Regulatory Documents
as per requirement
Business potential align with
Regulatory Strategy
Promotion of product
Regulatory Affairs Department
Central Position in Industry
API import , export of FP
Validation/ Controls
as per regulation
Stability Studies
Distribution practices

7
Why is Regulatory Affairs Needed?
• To put better control on Drug development and
commercialization
• The path to drug registration (Marketing
Approval) is paved with good intention but
can be complicated
• Things change....constantly!

Role of Regulatory Affairs Pharmacist
• To keep track of the ever changing
legislation
• Registration of company and product in
respective markets
• Life Cycle management of product and
company
• To file variation to Health Authorities
• To give strategic and technical advice to
R&D, Production, QC and Quality
assurance
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• Construction of core dossier
• Global regulatory strategies
• Core labelling profile
• IND, CTA, NDA, MAA
• Scientific advice •
• Due-diligence/RI
• Global SOPs
• Pharmacovigilance
• Medical
• ePublishing
• Global business development
• Country/Region specific data
• Product information
• Local developments and
specific variations
• Local/regional RA strategies
• Technical support, CTAs
• Pharmacovigilance
• Due-diligence/RI
• Local SOPs
• Medico-Marketing
• ePublishing
• Local business development
Corporate/ Central Regional /local
REGULATORY AFFAIRS PHARMACIST

Strategic Importance of Regulatory Affairs Pharmacist
10
• Regulatory expertise required throughout the
product lifecycle
• Identification of various regulatory options for drug
development
• Optimizing and speeding “time-to-market”–
• Engagement in manufacturing site optimization
activities
• Engagement in portfolio optimization activities
• Engagement during Merger, Demerger &
Divestment activities
• Engagement in critical business functions

11
COMPANY REGISTRATION
&
PRODUCT REGISTRATION

Requirement for registration
of Company
Page:12
Company registration prior to product registration
Companies ( sites ) for conventional , general sale , medical devices and
herbal should be registered by health authorities
Approval time 3-6 months
EXAMPLE OF REQUESTED INFORMATION
Application form of UAE
GMP
Letter of agency authorization
Legalized company License
List of subsidiaries
List of products produced by company
List of countries where company is registered
Research information
Receipt of fees information
Company profile
List of associated manufacturing faculties

PRODUCT REGISTRATION
13

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15

16

Emerging Markets
17
NOT

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The Regulatory Submission
Building the CTD Pyramid
Data
Summaries
Product information
Summary of Product
Characteristics
Administrative
information
The Regulatory Submission

19
COMPREHENSIVE TABLE OF CONTENTS (MODULE 1 – 5)
Module 1 Administrative Information
1.1 Comprehensive tablet of contents
1.2 Application form
1.3 Product information
1.3.1 SPC, labelling and package leaflet
1.3.2 Mock up
1.3.3 Specimen
1.3.4 Consultation with target patient groups
1.3.5 Product information already approved in the member states
1.3.6 Braille
1.4 Information about the experts
1.4.1 Quality
1.4.2 Non-clinical
1.4.3 Clinical
1.5 Specific requirements for different types of applications
1.5.1 Information for bibliographical applications
1.5.2 Information for generic, ‘hybrid’ or bio-similar applications
1.5.3 (Extended) Data/market exclusivity
1.5.4 Exceptional circumstances
1.5.5 Conditional marketing authorization
1.6 Environmental risk assessment
1.6.1 Non-GMO
1.6.2 GMO
1.7 Information relating to orphan market exclusivity
1.7.1 Similarity
1.7.2 Market exclusivity
1.8 Information relating to pharmacovigilance
1.8.1 Pharmacovigilance system
1.8.2 Risk management system
1.9 Information relating to clinical trials

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Module 3 Drug Substance (DS)
Section Title Functional Area
3.1 Table of Contents
3.2 Body of Data
3.2.S Drug Substance
3.2.S.1 General Information DS Characterization
3.2.S.2 Manufacture DS Manufacture
3.2.S.3 Characterization DS Characterization
3.2.S.4 Control of Drug Substance Analytical
3.2.S.5 Reference Standard Analytical
3.2.S.6 Container Closure System DS Manufacture
3.2.S.7 Stability Stability

21
Module 3 Drug Product (DP)
Section Title Functional Area
3.2.P DRUG PRODUCT
3.2.P.1 Description & Composition DP Manufacture
3.2.P.2 Pharmaceutical Development DP Manufacture
3.2.P.3 Manufacture DP Manufacture
3.2.P.4 Control of Excipients Analytical
3.2.P.5 Control of Drug Product Analytical
3.2.P.6 Reference Standard Analytical
3.2.P.7 Container Closure System DP Manufacture
3.2.P.8 Stability Stability

22
Module 4 Non-clinical Study Reports
4.1. Table of Contents
4.2 Study Reports
4.3 Literature References
Module 5 Clinical Study Reports
5.1 Table of Contents
5.2 Tabular Listing of all Clinical Studies
5.3 Clinical Study Reports
5.4 Literature References

Julphar.net
Variations
Any change(s) to the information approved in the marketing authorization
application
Health authority must be notified as per the variation regulations and
procedures to ensure REGULATORY COMPLIANCE
In GCC, variations are governed by GCC Guidelines for Variation
Requirements, adapted from Europe Regulation (EC) No. 1234/2008 Article
4(1)a

25
Regulations in Middle East

26
HealthCare
Health care USD $ 12
Billion market growth
rate over 10 %
74.6 % of
pharmaceutical are on
imports basis
Very Vibrant domestic
pharmaceutical markets
e.g. . Iran, Egypt 90 %
of consumption in Egypt
based on local
production vs. Saudia
Arabia with 85 %
pharmaceutical
consumption being
imported
Healthcare has strong
ties to the WEST
Drug price controlled by
Government
Data exclusivity 5 years
from date of MA
Pharmaceutical environment
Young Population – will be doubled
by 2030
Government development plans in
MENA REGION
Need to develop hospitals and
clinics
Implementing insurance schemes
Necessity for trained staff
Need to strengthen public
surveillance system
CULTURE - Regional Trends
UNITED ARAB EMIRATES (UAE )
Area 83,6000 km and population is 4.8 million growth 3.7%
85% of the labor force is expatriates
GDP US$ 201.4 bn GDP capita US $ 42,000
UAE is spending US$ 2.9 bn on various healthcare projects
Dubai and Abu Dhabi introduced universal health insurance models
during 2008
Pharmaceutical markets – 65% private and 35 % Governmental
tenders and institutions
Market split : patented drugs 67.7 % Generic 14.6% , OTC 17.7%
Health expenditure US $ bn 6.9
RAK Medical & Health sciences University RAK College of
Pharmaceutical Sciences

0
200
400
600
800
1000
1200
1400
China India MENA +
Turkey
USA Brazil Russia
1338 1210
396.2 311 195 142
74
0
5
10
15
20
Brazil Russia MENA +
Turkey
China India
10.8 10.5
7.7
4.4
1.3
10.4
Why MENA REGION ?
 MENA contains 6.7% of the
world's population, about
the same as the population
of the EU.
 Turkey and MENA have the
4th largest population in
the world.
 The GDP per capita (MENA
+ Turkey) > $18K nearly
double of Brazil and Russia.
 The healthcare
expenditure per capita in
MENA has significant room
for growth.
(only US$ 183 in Y2009)
27
Source: IMF - PWC – World Bank
GDPpercapital(US$)PopulationMM

MARKET COMPOSITION OF GCC
28

Your Asset
Your Partner
Healthcare
Regulations
Local Giants
&
Competition
Complex &
lengthy
registrations
Pricing
Pressures
Tenders
unified
purchasing
Loose IP
The environment in MENA
• Protectionist & nationalistic approach
adopted by most of the countries- trend
of local protectionist laws favoring
local manufacturing (Algeria, Egypt,
Tunisia, Morocco, Turkey )
• Lengthy and bureaucratic marketing
authorization processes
• Difficulty to find reliable and
successful partners
• Potential for growth but fragmented
and competitive landscape with many
local and multinational players
• Trend of local governments to decrease
health costs (obligatory price decreases
in Saudi Arabia, reference pricing in
Algeria, etc…) 29
The Common Themes

Gulf Corporate Council of the Arab
States (GCC )
Vision – Highly effective and safe use of
medication to protect the Community health
in Gulf states
Mission – Establishing a unified registration
system that ensures effectiveness, safety
and quality of medicine
Member states – Saudia Arabia, Kuwait ,
UAE Oman , Bahrain , Qatar and Yemen
Main Office – Riyadh ( KSA )
Meeting frequency – 4 meetings /year
GCC – publish guideline regarding registration , GMP, Pharmacovigilance etc
Company registration – first step for new entries in GCC , registration fee is 2700
US $
Product registration – Format of dossier is CTD , administrative review by two
members states , lab analysis - GCC registration Certificate issued , registration
fee is 2450 US $
30

Tender Business in the Middle East
SGH ( SECRETARIAT GENERAL OF HEALTH – TENDER )
• Unified purchase program establish in 1978
• Tender Volume – 1.5 bn US $
• 424 International and local companies are accredited
• Tender is presented annually and permanent committee evaluate the applications
• Purchase - under control of WTO especially for the pharmaceutical medicine
• Tender announced – end of March and closing date end of April
• Preliminary award information – 2-3 weeks after closing date
• Final award Information - 22-24 weeks after closing , within 45 days 5 % of awarded
amount suppose to pay
• 3 partial shipment in 4 months interval
31

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Regulations in Middle East

33
Models for regulation of medicines are
determined by:
• Public health needs
• Organization of the state and state administration
• Size of the pharmaceutical market
• Presence and type of pharmaceutical industry
• Availability of resources (human, scientific, financial)
• Maturity of stakeholders
• Participation in regulatory networks
Medicine Regulation

36
The Regulatory Partners
PATIENTS
Government (HA)
Pharmaceutical
Industries
Professional
Bodies

37
The Regulatory Guidelines
International
r
INTERNATIONAL GUIDELINES
REGIONAL GUIDELINES
LOCAL GUIDELINES

UAE
• The UAE’s drug market is dominated in value
terms by foreign MNCs.
• Most major research-based firms have a long-
standing presence in the UAE, either via
contract manufacturing or local distribution
arrangements.
• The UAE does have a thriving biotech and
domestic pharmaceutical industry, which the
government is keen to boost. The authorities
are, therefore, likely to alter their import
policies, favoring local production where
possible
• The Pharmaceutical & Medicine Control Dep.
is the main pharmaceutical regulatory division
within the MoH
• Products with US, EU or Japanese approval
experience less difficulty in gaining access to
the market.
• Asks for US FDA or EU manufacturing license
to accept the importation & registration
• Fx rate on the pharmaceutical market; Dirham
vs. Euro
Local Enviroment Regulatory Regime
2011 Drug Market Size1:US$1,5 bn (AED
5,6bn)
2016 Drug Market Size1:US$2,3 bn (AED
8,4bn)
CAGR 2011-20161: 8,5% (local currency &
USD)
Pharmaceutical Spend (2011)1: 0,4% of
GDP
Pharma % of Health expen. (2011)1:12,3%
Healthcare Spend (2011)1: 3,52% of GDP
By numbers
• One of the more developed markets in the Middle East, with a strong healthcare infrastructure and the highest per-capita drug
expenditure in the region.
• Strong patented drug market, largely as a result of the country’s traditional wealth and a preference for the latest medicines.
• Local manufacturing industry activity has increased notably over the past few years, with a strong focus on regional and global exports.
• Increase in population numbers, including expatriates, feeding through to significantly higher healthcare expenditure.
• Although improving, domestic patent law is below international standards.
• Market is reliant on imports, in particular at the hi-tech end of the scale.
• Disparate regulations between different parts of the Emirates, which are likely to be further complicated by the introduction of new
structures in Dubai.
• Shake-up of the laws limiting foreign ownership is expected to boost investment.
• Introduction of integrated healthcare insurance system.
1. BMI Pharmaceutical and Healthcare Report Q3 2012
38

UAE
Biosimilar Update; Drivers vs. Resistors
Drivers
UAE Biosimilar Industry
Resistors
UAE Biosimilar Industry
- Highest per-capital
spending for
pharmaceuticals in the
region
- Regionally fragmented
healthcare system and
insurance coverage,
leading to an uneven
access to healthcare
services
- Loose IPR
- Increasing generics usage
in Abu Dhabi in accordance
to the basic insurance
policies
- The UAE pharma market
has retained a strong
preference for originator,
branded products
- Only considered if EMA or
FDA approved
- No Biosimilar regulation
yet
39
Saudi
31%
Algeria
21%
Egypt
21%
UAE
11%
Morocco
8%
Local/regional company
21
26
27
28
30
39
43
59
63
72
78
J&J
ROCHE
JULPHAR
BAYER
ABBOTT
ASTRAZENECA
SANOFI
MERCK & CO
PFIZER
NOVARTIS
GSK
Market dominated
by MNCs
2011 Total sales in MENA (Public + Retail)
IMS 2011- USD ‘ MM

KSA
• 27 pharmaceutical manufacturing factories
currently operating in Saudi Arabia. Most are
generic drug manufacturers, including TABUK,
SPIMACO, al-Jazeera, Dar Al Dawa, Riyad
Pharma.
• Imports continue to account for the bulk of
total spending, although government support
has the potential to stimulate export growth
of local firms, as well as the local use of
generic medicines.
• The market reliance on imports, particularly at
the hi-tech end of the scale.
• All pharmaceutical companies to be
registered (6-18 months for registration,
registation renewal every five years)
• MoH and SFDA – transition period
• Guidelines include the stipulation that drugs
launched in Saudi Arabia must have already
been marketed in developed countries (US,
UK)
• Products also have to be manufactured in the
same plant as those destined for the US or UK
• Strict control over the pricing system – a
significant deterrent to market access.
• 1st generic – 70% of originator price
• Next – 90% of previously intr. generic
2011 Drug Market Size1:$4,46bn (SAR
16,70bn)
2016 Drug Market Size1:$7,00bn (SAR
26,23bn)
CAGR 2011-20161: 9,5% (local currency &
USD)
Pharmaceutical Spend (2011)1: 0,77% of
GDP
Pharma % of Health expen. (2011)1: 21,23%
By Numbers
The largest pharmaceutical market in the MENA region (over half of the total), with steady growth expectation and foreseeable future
• Rapidly expanding population, with more diseases of ‘urbanization’ in evidence.
• Rising government investment in the local drug industry.
• Aaccelerating modernization and expansion of healthcare infrastructure and provision.
• Complex nature of the domestic regulatory system restricting the entry of multinationals and drug makers from developing countries
such as India.
• Market entry delays due to requirements for laboratory testing in the country.
• Reference pricing to other markets negatively affecting price levels in Saudi Arabia.
• Inadequate protection for patented pharmaceutical products.
40

71
83
87
88
98
114
114
127
150
200
214
JULPHAR
SANOFI
JAMJOOM
MERCK & CO
ABBOTT
TABUK
HIKMA
NOVARTIS
PFIZER
GSK
SPIMACO
KSA
Drivers
S.Arabia Biosimilar Industry
Resistors
S.Arabia Biosimilar Industry
- Biosimilar* definition in
place with Guidelines on
Biosimilars version 1.1, Dec
2010
- Rising chronic disease
burden
- Increasing generic usage as
a result of the efforts of
the Government to lower
pharmaceutical costs
- Fluctuating oil prices
affecting healthcare
budgets
- COFO (subsequently
developed country – US &
EU- launch)
- The relative wealth of the
population acts as a
significant barrier to
market expansion, as there
is little demand for low
cost drugs.
- Still very low generic drugs
penetration (< 7.7% of the
market by value)
- Reference pricing
- Technology Transfer
expectation
- In Government tenders,
preferences are normally
granted to local or GCC-
based companies
1. Saudi Arabia December 2010 Guidelines on Biosimilars version 1.1
41
Saudi
31%
Algeria
21%
Egypt
21%
UAE
11%
Morocco
8%
Both
strong local and
MNC players

Egypt
• Egypt has 212 pharmaceuticals factories,
with local product development focused on
drug formulation rrather than research 61
with partnership and 18 foreign companies
• Well-established manufacturing industry
comprised of many privately owned local
companies, focusing on high-volume basic
medicines.
• Local production of finished pharmaceuticals
accounts for around 90% of domestic
consumption, with imports limited to
patented and difficult to manufacture
products.
• Regulatory process is complex and many
committee review process
• Lack of resources
• Pricing could be an obstacle to launch a
product ---new pricing decree required list of
product in 36 countries and Egypt price would
be 10 % lowest price in the list
• New product should be registered and
marketed for one year in reference country
• CAPA is Regulatory body in Egypt
• CPP of Country of Origin is required to
submit the file
• Lose IP
2011 Drug Market Size1:US$3,07bn
(EGP 18,23bn)
2016 Drug Market Size1:US$5,51bn
(EGP 31,97bn)
CAGR 2011-20161: 11,9% (local currency)
Pharmaceutical Spend (2011)1: 1,3% of GDP
Pharma per capita sales (2011)1 : US$37,1
By numbers
• .Egypt is the largest consumer of pharmaceuticals in the MENA region
• Egypt has 1969 private and governmental hospitals & 5034 primary health care units
• Egypt has a fragmented health system with multiple sources of financing and providers.
• Spending on pharmaceuticals is 34 % of total health care spending*.
• Share of out-of-pocket spending to total health spending has increased from 51 % to 72 %*
.
• The most recent pricing policy has received much criticism from Egyptian and multinational companies operating in the country, leading
to the program being suspended until purchasing power parity is better reflected
42

Egypt
Drivers
Egypt Biosimilar Industry
Resistors
Egypt Biosimilar Industry
- Per capita spending will
remain low, and the need
for affordable medicines
- Poor Intellectual Property
protection ; early entry
opportunity
- Registration is highly
complex w/ multi
committees and reviews
- Inflexible pricing
regulations
- Bio -similar guidelines are
drafted and implemented
in 2013
- CPP requirement
43
Saudi
31%
Algeria
21%
Egypt
21%
UAE
11%
Morocco
8%
IMS 2011 - USD ‘ MM (Retail only)
54
59
65
75
89
111
125
126
159
163
169
MUP
MINAPHARM
EVA
PFIZER
SIGMA
SANOFI
AMOUN (APC)
EIPICO
PHARCO
NOVARTIS
GLAXOSMITHKLINE
Strong &
experienced
local players

Iraq
44
• The Iraq’s drug market is dominated in value
terms by foreign MNCs.
• Most major research-based firms have a long-
standing presence in the Iraq , either via
contract manufacturing or local distribution
arrangements.
• The Iraq does have a thriving biotech and
domestic pharmaceutical industry, which the
government is keen to boost. The authorities
are, therefore, likely to alter their import
policies, favoring local production where
possible
The Pharmaceutical & Medicine Control Dep. is
the main pharmaceutical regulatory division
within the MoH
• Products with US, EU or Japanese approval
experience less difficulty in gaining access to
the market.
• Asks for US FDA or EU manufacturing license
to accept the importation & registration
201 2 Drug Market Size1:US$ 2.19 bn
 (2016 Drug Market Size1:US$ 3.9 bn.
CAGR 2011-20161: 14. 1% (local currency &
USD)
Pharmaceutical Spend (2013)1: 0,4% of GDP
Healthcare Spend (2013)1: 9.28 % of GDP
By numbers
• Iraq's economy is one of the fastest growing in the region, and increased revenues from oil
ensure that the government will have funds to dedicate to improving healthcare services
• Strong growth of pharmaceutical sales, based largely on volume drivers.
• Overall healthcare sector set to expand strongly.
• Higher total pharmaceutical spending than many markets in the region based on large
and expanding population numbers.
• Limited competition between domestic and foreign companies.
• Improved intellectual property regime as a result of post-2003 changes to legislation.
• High-potential demographic and epidemiological profiles.

• Pricing Unification
Harmonization Initiatives
• IPR
• Technical landscape
• B.E current guidelines & trends (Module 5)
• Manufacturing flow strategies
• Common guidelines of Biosimilars
• Harmonization initiatives of eCTD, 2D barcodes
GTIN and GLN codes Implementation
• P.V evolution

48
Increasing population base
Increasing Income
Increasing Insurance penetration
Higher incidence of life style disease
Rising number of senior citizens
High population growth
Impeding Factors
Un-organized Regulatory
Environment
Less conducive payer
model
Lower incidence of
communicable diseases
Opportunities & Threats
Stimulating growth factors of Private
Sector outweigh impeding factors

49
JULPHAR

50
Head of Government Affairs Middle East
Gilead Sciences
Dubai, Dubai, United Arab Emirates Dec 14, 2015
Regulatory Affairs Manager
Connect Executive Search Middle East
Dubai, UAE Dec 7, 2015
International and Government Affairs Manager
Emirates
United Arab Emirates Dec 10, 2015
CHC Regulatory Affairs Manager NEME
Boehringer Ingelheim
Dubai, AE Dec 1, 2015From jobs.boehringer-ingelheim.com
Director, EMEA Regulatory Affairs Lifecycle Innovation - Medical Devices
Johnson & Johnson
Dubai, AEO Oct 24, 2015From jobs.jnj.com
SCOPE OF REGULATORY AFFAIRS

Sharing is not new, our Moms taught us
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Sharing is not new, our Moms taught us to do it!
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