Rak presentation

Regulatory Environment in the Middle Eastopportunities & challenges

Mamoona Firdous Naqvi

Dec16,2015

RAK Medical & Health sciences University

RAK College of Pharmaceutical Sciences

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

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Julphar 6 2

Opportunities and Challenges

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What is Regulatory Affairs?Regulatory Affairs: It is a unique mix of science and management tofull 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


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Regulatory Affairs

Regulatory Affairs

Medical

Business Developmen

t

Finance

PRODUCT DEVELOPMENT

MARKETING SALE

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


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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!


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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

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• 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


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COMPANY REGISTRATION & PRODUCT REGISTRATION

Requirement for registrationof Company

Page:12

Company registration prior to product registrationCompanies ( sites ) for conventional , general sale , medical devices and herbal should be registered by health authorities Approval time 3-6 months

EXAMPLE OF REQUESTED INFORMATIONApplication form of UAEGMP Letter of agency authorization Legalized company LicenseList of subsidiaries List of products produced by company List of countries where company is registered Research information Receipt of fees informationCompany profile List of associated manufacturing faculties


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PRODUCT REGISTRATION


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Emerging Markets

ONE DOES FİT TO ALL

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NOT

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The Regulatory SubmissionBuilding the CTD Pyramid

Data

Summaries

Product information

Summary of ProductCharacteristics

Administrativeinformation

The Regulatory Submission

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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 Area3.1 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

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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

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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

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eCTD

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


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Regulations in Middle East

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HealthCare

Health care USD $ 12 Billion market growth rate over 10 %74.6 % of pharmaceutical are on imports basisVery 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 2030Government development plans in MENA REGIONNeed to develop hospitals and clinics Implementing insurance schemes Necessity for trained staffNeed 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 expatriatesGDP US$ 201.4 bn GDP capita US $ 42,000UAE 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



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China India MENA + Turkey

USA Brazil Russia0

200

400

600

800

1000

1200

1400

1338 1210

396.2 311 195 142

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Brazil Russia MENA + Turkey

China India02468

101214161820

10.8 10.57.7

4.41.3

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)

Source: IMF - PWC – World Bank

GDP per capital (US$)

Population MM


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MARKET COMPOSITION OF GCC

Your AssetYour 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

RAK Medical & Health sciences University RAK College of Pharmaceutical

Sciences


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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 $


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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


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Regulations in Middle East


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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

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The Regulatory Partners

PATIENTS

Government (HA)

Pharmaceutical Industries

Professional Bodies

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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 Regime2011 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 GDPPharma % 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

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UAEBiosimilar 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

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Saudi31%

Algeria21%

Egypt21%

UAE10%

Morocco8%

Local/regional company

J&J

ROCHE

JULPHAR

BAYER

ABBOTT

ASTRAZENECA

SANOFI

MERCK & CO

PFIZER

NOVARTIS

GSK

21,426

25,534

27,377

27,765

29,635

39,447

43,458

59,100

62,957

72,398

77,954

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

Local Enviroment Regulatory Regime

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 GDPPharma % of Health expen. (2011)1: 21,23%Healthcare Spend (2011)1: 3,64% of GDP

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.


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JULPHAR

SANOFI

JAMJOOM

MERCK & CO

ABBOTT

TABUK

HIKMA

NOVARTIS

PFIZER

GSK

SPIMACO

70,569

83,210

87,461

88,306

97,508

113,738

114,204

126,591

150,392

200,007

213,883

KSABiosimilar Update; Drivers vs. Resistors

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

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Saudi31%

Algeria21%

Egypt21%

UAE10%

Morocco8%

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 % of Health expen. (2011)1:29,3%

Healthcare Spend (2011)1: 4,37% 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


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EgyptBiosimilar Update; Drivers vs. Resistors

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

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Saudi31%

Algeria21%

Egypt21%

UAE10%

Morocco8%

IMS 2011 - USD ‘ MM (Retail only)


MUP

MINAPHARM

EVA

PFIZER

SIGMA

SANOFI

AMOUN (APC)

EIPICO

PHARCO

NOVARTIS

GLAXOSMITHKLINE

53,602

58,779

65,148

74,652

89,382

110,818

124,742

126,126

158,986

162,843

168,838

Strong & experienced local players



Iraq

RAK Medical & Health sciences University RAK College of Pharmaceutical

Sciences

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• 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

Pharma % of Health expen. (2013)1:12,3%

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


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Increasing population base Increasing Income Increasing Insurance penetrationHigher incidence of life style diseaseRising number of senior citizensHigh 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


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JULPHAR


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Head of Government Affairs Middle EastGilead SciencesDubai, Dubai, United Arab Emirates Dec 14, 2015

Regulatory Affairs ManagerConnect Executive Search Middle EastDubai, UAE Dec 7, 2015

International and Government Affairs ManagerEmiratesUnited Arab Emirates Dec 10, 2015

CHC Regulatory Affairs Manager NEMEBoehringer IngelheimDubai, AE Dec 1, 2015From jobs.boehringer-ingelheim.com

Director, EMEA Regulatory Affairs Lifecycle Innovation - Medical DevicesJohnson & JohnsonDubai, AEO Oct 24, 2015From jobs.jnj.com

SCOPE OF REGULATORY AFFAIRS


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


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Thanks aLL


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Rak presentation

Healthcare

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