Review of the 9th Middle East Regulatory Conference - Drug ...

Adrian D. Ball, BMedSc 

(Hons) 

Senior Regulatory 

Affairs Manager, UCB 

Pharma S.A., Belgium 

Mike Fallows, PhD 

Middle East and Africa 

Regulatory Director, 

AstraZeneca, 

United Kingdom 

Key Words 

ICH CTD; 

Pharmacovigilance; 

Biological; Biosimilar; 

Variations; Falsified 

medicines 

Correspondence Address 

Adrian D. Ball (email: 

adrian.ball@ucb.com). 

Review of the 9th Middle East Regulatory 

Conference 

The 9th Middle East Regulatory Conference 

(MERC) was attended by over 250 delegates 

from pharmaceutical companies from around 

the world, as well as numerous Middle East 

health authorities. The focus of the 9th MERC 

was on seven key and equally important sessions: 

• Local Regulatory Authorities’ Views and Key 

Issues (primarily focusing on key developments 

in Middle East regulatory authority 

frameworks and legislation) 

• The Global Regulatory Environment and 

i n t r o d u c t i o n 

The 9th Middle East Regulatory Conference 

(MERC) took place in Amman, Jordan, on February 

1–2, 2011, with over 250 delegates drawn 

from pharmaceutical companies around the 

world and numerous Middle Eastern health authorities. 

The continued growth in attendance 

at MERC reflects the growing importance of 

these emerging markets, the interest in the 

changing regulatory environment, and the challenges 

to both industry and regulators in the 

shared goal of bringing safe and efficacious, 

quality medicines to patients in the region as 

fast as possible. 

Professor Trevor Jones, CBE, Kings College 

London, WHO Commissioner, CIPHH, UK, 

chaired the conference and gave an introduction 

that referenced the European Medicines 

Agency (EMA) roadmap 2015, in which 

three strategic areas were identified: 

• Addressing public health needs 

• Facilitating patient access to medicines 

• Optimizing use of medicines 

Such themes were equally relevant to the Middle 

East and were reflected in the topics covered 

in the conference. 

Angelika MichaelisGilles, EFPIAMERN Chair, 

Senior Regulatory Affairs Manager, Grünenthal 

Drug Information Journal, Vol. 45, pp. 525–534, 2011 • 0092-8615/2011 

Printed in the USA. All rights reserved. Copyright © 2011 Drug Information Association, Inc. 

p r o c e e d i n g s 525 

Opportunities for the Middle East Authorities 

• Pharmacovigilance as a Tool to Monitor 

Pharmaceutical Products in Relation to Patient 

Safety 

• Biological Medicines and Their Associated 

Regulatory Complexity 

• Harmonization of Regulatory Documentation: 

Structure and Requirements 

• Future Trends in Harmonization and Collaboration 

for the Middle East Region 

• The Risk for Public Health in Relation to Falsified 

Medicines 

GmbH, Germany, provided an update on the 

EFPIAMiddle East Regulatory Network (MERN) 

and the progress made since MERC 2009. In 

particular, she highlighted the Middle East Regulatory 

Workshop in Dubai in November 2009, 

with the goal of streamlining the management 

of variations. The workshop was attended by 

ministry of health delegates from eight countries, 

together with local regulatory affairs 

groups. An indepth evaluation of the European 

Federation of Pharmaceutical Industries Association 

(EFPIA) position paper on the management 

of variations in CPPdependent countries 

took place, with focus on two main items: 

• A notification, that is, a “tell and do” process for 

labeling changes that increase the safe use of the 

drug product and minor quality changes 

• A “tell, wait, and do” process for other labeling 

changes and major quality changes 

The main proceedings and outcomes of the 

conference are captured below. 

L o c a L r e g u L at o r y a u t h o r i t i e s ’ 

V i e w s a n d K e y i s s u e s 

Key developments in regulatory authority 

frameworks and legislation were delivered by 

authorities from Jordan, Saudi Arabia, Iran, and 

the Gulf Cooperation Council (GCC). An exter

526 p r o c e e d i n g s Ball, Fallows 

nal comparison of the regulatory review process 

in the GCC was also shared with the conference. 

Jordan Food and drug 

administration 

dr Leila Jarrar, drug directorate director, 

Jordan Fda, presented the JFDA’s structure and 

department with focus on their points of 

strength due to qualified staff, scientific expertise, 

openness to regional and international 

meeting and exchange, and the increase in drug 

exports over imports. She spoke in depth about 

regulations implemented by the JFDA since 

MERC 2008, including guidance and legislation 

on biosimilar registration, clinical trials, 

and pharmacovigilance (JFDA legislation and 

guidelines are available on www.jfda.jo). JFDA’s 

future visions and targets were to be strategic, 

vigilant, quick, and visible, and Dr Jarrar actively 

promoted the harmonization of the regulatory 

guidelines in the region, which are in line 

with those of ICH. 

iranian nationaL drug and Food 

Laboratory 

dr mahmoud alebouyeh, head of the biological 

Laboratory of the iranian Food and 

drug Control Laboratory, presented new regulations 

in Iran for contract manufacturing of 

biopharmaceutical products. These guidelines 

are meant to encourage biopharmaceutical 

companies to invest in manufacturing facilities 

in Iran to produce finished drug products or at 

least some aspect of drug product manufacture 

(96% of biopharmaceutical products are 

locally manufactured in Iran; all information 

is available on www.fdo.ir). He spoke about the 

biosimilar registration process and pointed 

out the current local manufacture of biosimilar 

and other biological products is on the increase, 

with growing numbers of Iranianbased 

facilities. The pre and postmarketing surveillance 

was the last point highlighted by Dr 

Alebouyeh when he clarified the Iranian pharmacovigilance 

system and highlighted the in 

creasing number of adverse drug reports over 

the years. 

saudi arabia Food and 

drug authority 

dr hajed m. h. hashan, Executive director 

of Pharmaceutical Products registration department 

of the saudi arabia Food and drug 

authority (sFda), outlined the vision of the 

SFDA to become the leading drug regulatory authority 

in the Middle East. Dr Hashan informed 

the conference about the progress in the SFDA’s 

infrastructure, organization, and operational 

processes since its inception in 2009 (for further 

information see www.sfda.gov.sa). Furthermore, 

he pointed out that the SFDA has undertaken 

further internal projects (eg, drug registry 

procedure, counterfeit detection, ecoma, LIMS 

system, electronic tracking systems), all with the 

goal of the SFDA’s vision. More detailed guidance 

and legislation are being produced by the 

SFDA for biotechnology products. Dr Hashan 

highlighted the need to harmonize the regulatory 

environment throughout the Middle East 

and stressed the importance of cooperation between 

the Middle East regulatory authorities to 

streamline regulatory requirements and submission 

formats for the benefit of the whole region. 

guLF CooPEration CounCiL: 

drug rEgistration 

dr hajed m. h. hashan, on behalf of the 

gCC-dr, gave an overview of the members, regulatory 

initiatives, mission, scope, regulatory 

processes, and procedures of the GCCDR. All 

related information can be found at www.sgh 

.org.sa. He pointed out that the approval timelines 

have increased dramatically in the past two 

years due to limited human resources within the 

GCCDR and that a dramatic increase in regulatory 

submissions has occurred, with the consequence 

being a significant increase in good 

manufacturing practice compliance inspections. 

a ComParison oF rEguLatory 

rEviEw ProCEssEs and thE 

FaCtors inFLuEnCing thE QuaLity 

oF dECision making in gCC statEs 

dr reem al Essa from the welsh school of 

Pharmacy, Cardiff university, uk, presented

9th Middle East Regulatory Conference p r o c e e d i n g s 527 

to the conference her study, comparing regulatory 

review processes and factors influencing 

decision making in the GCC. The study focuses 

on regulatory affairs processes and the measures 

used to build quality into the regulatory 

review process, and how this improves decisionmaking 

processes in GCC regulatory authorities. 

From Dr Essa’s findings, her conclusions 

were that the majority of GCC authorities 

should deploy some form of training and continuous 

education programs for their reviewing 

staff, that joint reviews, as part of the GCCDR 

system, should take place, and that a wide range 

of activities should occur to improve communication 

with the pharmaceutical industry and 

transparency with the public. 

Her key recommendations were adoption of 

a standardized regulatory assessment template 

and parallel assessment of sample analysis and 

pricing with the scientific assessment process 

to improve patients’ access time, engagement of 

external quality audits by accredited external 

certification bodies, and improvement of transparency 

to increase confidence in their review 

practices. 

g L o b a L r e g u L at o r y 

e n V i r o n m e n t a n d o p p o r t u n i t i e s 

f o r t h e m i d d L e e a s t 

This session was to raise awareness of the global 

regulatory environment outside the Middle 

East and to present an overview of its impact on 

local Middle Eastern regulatory authorities. 

Presentations from both aspects were given 

with key recommendations in variation management 

for consideration in the future. 

variation managEmEnt and FuturE 

trEnds in thE Eu 

dr Christa wirthumer-hoche, head of marketing 

authorization of medicinal Products 

and Lifecycle management, agEs Pharmmed, 

austria, presented the new EU variation 

guidelines that came into force at the beginning 

of 2010. This included the different classification 

of changes, that is, Type IA (minor variations), 

Type II (major changes), and Type IB (by 

Drug Information Journal 

default, ie, neither a Type IA or II nor an extension). 

The objective was to introduce simpler and 

more flexible guidelines to reduce the administrative 

burden for both the industry and the authorities. 

This new variation guideline covers changes 

to all EU procedures (centralized, mutual recognition, 

decentralized, national) and is applicable 

to both human and veterinary products. 

The guidelines are published on the DG 

Health website (EC 1234/2008) and should be 

referred to for a better understanding of the 

classification of the different variations and the 

regulatory conditions to be fulfilled. 

variation managEmEnt in thE middLE 

East: LoCaL ExPEriEnCEs 

dr ramy behbehani, a registration and release 

superintendent from the kuwait Food 

and drug Control administration (kFdC), 

started by providing a definition of a variation 

and the need for a change in the requirements 

to protect public health by better use of medicines. 

Enabling faster implementation of scientific 

progress for the benefit of patients should 

be industry and regulators’ goal. 

He explained how variations are currently 

managed in Kuwait, referencing Guidelines Decree 

302/80 (recently amended by adding annex 

no. 7), which categorized each variation according 

to its type and also provided a list of 

regulatory requirements to be submitted for the 

change. The categories of the variations were in 

line with those adopted by other competent 

Middle East regulatory authorities. 

In terms of approvals, according to the current 

guidelines, the market authorization holder 

should wait for approval from the KFDC before 

implementing the proposed changes. His 

proposal for the conference to consider, in line 

with EU variation guidelines (tell and do, tell, 

wait and do process) and the EFPIA position paper 

on the management of variation, was to harmonize 

with the EU regulations so as to avoid 

duplication, simplify regulatory review, and 

speed up the approval process.


p r e - a n d p o s t m a r K e t i n g 

s a f e t y a n d p h a r m a c o V i g i L a n c e 

a s a t o o L t o m o n i t o r 

p h a r m a c e u t i c a L p r o d u c t s 

This session’s subject matter was to discuss tools 

that contribute to the continual monitoring of 

pharmaceutical products in relation to patient 

safety. This provided significant debate during 

the conference as both industry and regulatory 

authorities prioritize patient safety as key in 

pharmaceutical development. 

sFda PharmaCovigiLanCE uPdatE 

dr ghazi s. saeed, director of Pharmacovigilance 

department, sFda, saudi arabia, 

highlighted that establishing a postmarketing 

surveillance program is a strategic imperative to 

contribute to the protection of public health. 

This can be achieved by monitoring the safety 

and quality of medicines and by ensuring access 

to uptodate safety information on medicines 

to patients and health providers. During 

his presentation, Dr Saeed gave an overview of 

SFDA achievements and a summary of the reporting 

process and tools. 

Besides the National Pharmacovigilance 

Center (NPC) creation (which has been operational 

since March 2009), awareness measures 

were taken to improve the reporting culture, 

and guidelines were issued for pharmacovigilance 

obligations and reporting. One of the 

strategies for making the reporting plan successful 

is the organization of pharmacovigilance 

campaigns, and so far 37 workshops have 

been held and more than 4,000 health care 

professionals trained in adverse drug reactions 

(ADRs) and reporting across the country with 

the help of 62 coordinators from major hospitals. 

Dr Saeed illustrated the reporting figures, 

since the deployment of NPC, consisting of serious 

events. 

Dr Saeed went on to explain the role of the 

pharmacovigilance department’s advisory committee. 

The committee’s main responsibilities 

are assessing signal detection, periodic safety 

update reports, and implementing consequential 

actions on labeling to revoke marketing au 

thorizations based on safety concerns. The success 

of this committee is due to its regular 

meetings and the extensive training of the department’s 

staff. 

Dr Saeed concluded that tackling the underreporting 

of ADRs is imperative and continuing 

efforts in safety monitoring will contribute to 

the future safety of patients. 

PharmaCovigiLanCE: rEviEw 

oF intErnationaL aPProaChEs 

and trEnds 

sten olsson, Chief who Programme officer, 

uppsala monitoring Centre, who Collaborating 

Centre for international drug monitoring, 

sweden, introduced his presentation 

by reminding the audience that pharmacovigilance 

covers adverse effects but also product 

quality, inadequate use, and safety challenges of 

mass treatment campaigns. He pointed out that 

spontaneous reporting is the backbone of any 

pharmacovigilance system and the value for 

having collected data over the world. In the last 

15 years the number of member countries of 

the WHO program for international drug monitoring 

has more than doubled (104 including 

Oman, Iran, Egypt, Jordan, Saudi Arabia, and 

Iraq), allowing a significant growth of the WHO 

database (VigiBase, storing around 6,000,000 

individual safety case reports), but the ongoing 

challenge is to expand member countries and 

reporting. 

Mr Olsson detailed the different national system 

approaches, in terms of organization, affiliation, 

and regulation. VigiBase allows comparisons 

in terms of rate of reporting to be made. 

Despite some Middle East countries having a 

more dynamic reporting rate, it is unfortunate 

that the overall rate remains low compared to 

global trends, and the frequency of reporting to 

VigiBase needs to increase across the Middle 

East region. 

In conclusion, having functional pharmacovigilance 

systems becomes a necessity with the 

increase of global access to medicines and is 

supported by global health initiatives and 

WHO. Mr Olsson informed the conference that


as part of a joint WHO/Global Fund strategy, facilitating 

documents have been made available, 

and WHO is committed to providing relevant 

services to all countries. The demand for training 

remains a bottleneck where capacity scaleup 

is needed. 

t h e r o L e o f r e s e a r c h a n d 

d e V e L o p m e n t i n pat i e n t 

a c c e s s t o n e w m e d i c i n e s 

The theme of this subject was to explore biological 

medicines and their associated regulatory 

complexity. Speakers from industry and regulatory 

authorities gave compelling presentations 

on biological and biosimilar products. 

biosimiLar guidanCE: 

Luxury or nECEssity 

dr thomas schreitmueller, head, regulatory 

Policy and strategy biologics, hoffmann La 

roche Ltd, basel, switzerland, explained that 

biologics are large and very complex molecules 

and that their manufacturing process confers 

unique properties that make them not identical 

to the original molecule. He shared examples of 

modifications that can take place with biologics 

(deamidation, glycation, sialylation, methionine 

oxidation, etc) inherent or due to the manufacturing 

process, which may result in approximately 

10 8 potential variants. Dr Schreitmueller 

explained that manufacturers of biological 

products must comply with an extensive set of 

regulations and guidance documents to ensure 

quality and safety of biological products, giving 

the US FDA, EMA, and ICH as examples. The 

speaker concluded that all biosimilars must undergo 

stepwise and headtohead comparisons, 

including comparative quality, nonclinical, and 

clinical studies to the same reference requested. 

He informed the conference that if major differences 

are found in the quality, nonclinical, and 

clinical studies, the product should not be considered 

similar and, therefore, other options for 

its further development should be considered 

(eg, full development). Dr Schreit mueller shared 

that countries adopting EMA or WHO guidance 

will have robust biosimilar approval pathways. 


biosimiLar mEdiCinaL ProduCts: 

Eu ExPEriEnCE and PErsPECtivEs 

Pr Jean-hugues trouvin, bwP Chair, Ema, 

and scientific advisor for biological/biotech 

products, aFssaPs, France, highlighted the 

regulatory framework fact that in the 2000s, 

many marketing authorizations of biological 

products expired (hGh, EPO, GCSF, etc) and 

the regulators were obliged to elaborate a status 

of biosimilars in Europe. This was because biologicals 

are complex at molecular levels and 

characterization and quality controls are complex 

as a consequence. Therefore the bioequivalence 

parameters used for assessing generics 

are not sufficient and relevant for biologicals. 

In Europe, the legal framework for biosimilars 

was introduced in 2003. Guidelines for quality, 

nonclinical, and clinical studies to accompany 

biosimilar status were presented. Pr Trouvin focused 

his presentation on the biosimilar concept 

and the comparability exercise. 

In conclusion, biosimilar does not mean generic. 

“Bio” means that this is a biological product, 

with all its complexity and consequences in 

terms of safety and efficacy. It is not recommended 

to switch patients from one biological 

product to another without therapeutic justification. 

The biosimilarity concept as well as the 

comparability program are not aimed at concluding 

that the two products are identical. 

“Similar” indicates the product’s administrative 

and regulatory status. 

sPECiFiCitiEs oF thE 

dEvELoPmEnt and rEgistration 

oF biosimiLars in EuroPE 

dr david uguen, Executive director of voisin 

Consulting Life sciences, France, focused his 

presentation on the biosimilar dossier content 

and the differences that may occur between the 

reference biological product and the biosimilar. 

Several biosimilar products are registered and 

marketed in Europe, and many more will come. 

A biosimilar is a biological product, similar to a 

reference biological medicinal product, is not a 

generic medicinal product, and requires the 

conduct of nonclinical and clinical studies be


fore registration. The reference biological product 

must be authorized in the EU on the basis 

of a complete dossier, used as reference 

throughout the full development (quality, safety, 

and efficacy) of the biosimilar, to allow generation 

of coherent data and conclusions, at the 

time of launch of the biosimilar. 

A biosimilar is not a generic because biologicals 

are more complex than chemical products 

and therefore more difficult to fully characterize. 

Subtle differences between biosimilars may 

not be apparent with today’s analytical methods. 

These subtle differences may be due to differences 

in raw materials or manufacturing processes 

and may relate to structural differences 

in the active substance or impurity profiles. 

These have an important impact on safety or efficacy 

and hence the need for nonclinical and 

clinical studies to be conducted. 

Dr Uguen’s takehome message was that biosimilar 

product development and dossiers are 

complex and as a consequence, comparative trials 

must be conducted to demonstrate similarity 

to the reference biological medicinal product. 

h a r m o n i Z at i o n o f 

d o c u m e n tat i o n f o r 

m a r K e t a c c e s s 

Moving on from MERC 8, this session presented 

an opportunity for discussion and feedback 

on how the Middle East regulatory authorities 

had progressed toward a harmonized ICHCTD 

structure and an opportunity for industry to 

present its perspective, with significant debate 

and collaboration. 

Ctd/E-Ctd: an Eu rEguLatory 

authority PErsPECtivE 

dr Christa wirthumer-hoche, agEs Pharmmed, 

vienna, austria, highlighted that the 

Common Technical Document (CTD) provides 

a common format and not necessarily common 

content and explained that until now CTD has 

been mandatory in the EU and eCTD is recommended 

and not yet mandatory, except in the 

case of esubmission. She spoke about an ongoing 

process to improve and develop a new major 

version of the eCTD including an eapplication 

form, product information management, and 

the perspective of the European agencies to 

have a European submission and tracking system 

via twoway electronic communication with 

the industry. 

sFda: ChaLLEngEs 

and LEssons LEarnEd 

hassaan al wohaibi, regulatory affairs manager 

at the sFda, saudi arabia, gave an overview 

of the experience of the SFDA in establishing 

its structure and organization from 2003 

until it become an operating organization in 

2009. He highlighted the challenges it faced in 

terms of infrastructure, processes, guidelines, 

and eservices. He presented statistics relating 

to SFDA regulatory submission meetings in 

2010; only 55% of sponsors attended preorganized 

regulatory submission meetings, and in 

most cases the SFDA had not received prior notice 

of cancellation. This was deemed by the entire 

conference an area for radical improvement. 

The presentation also discussed the CTD 

structure as a new concept, with reviewers requiring 

more experience, and concluded with 

the necessity of training in all aspects of dossier 

review and assessment. 

Ctd and E-Ctd submission 

rebekah Logan, director of regulatory affairs, 

Eli Lilly, usa, informed the audience 

that the CTD is a useful standard for formatting 

drug registration documentation. The speaker 

encouraged simple electronic submission standards 

(NeeS) to reduce use of resources. Ms Logan 

stated that while using CTD, compliance 

with the ICH definition of CTD is critical and 

only then can using CTD benefit the industry, 

agencies, and patients. 

She encouraged agencies to minimize their 

expectations for requesting customized countryspecific 

documentation beyond the ICH 

CTD content and that instead could rely on 

source country approvals as an additional 

source for information and/or on manufacturing 

site inspections. Ms Logan provided examples 

of countryspecific requests that are not


aligned with the ICH CTD content and suggested 

removal from regulatory requirements of 

signed and stamped specification documents 

from the manufacturer; validation of analytical 

procedures; request for assays of API and degradation 

products, especially with raw data and 

chromatograms; container closure system description 

of packaging material; raw stability 

data; chromatograms; and inuse stability information. 

In conclusion, harmonization to ICH CTD 

structure for pharmaceutical regulatory dossiers 

is encouraged, and authorities within the 

Middle East region are on the path to being 

successful in this. 

t h e c h a n g i n g 

r e g u L at o r y e n V i r o n m e n t 

Following on from discussions of the structure 

of a regulatory dossier, discussing the changing 

regulatory environment provided the conference 

with a medium to reflect on the progress 

of the Middle East region in relation to harmonization, 

legislation, and operating principles 

and to look toward the future regulatory environment. 

rEguLatory CooPEration 

and harmonization: bEnEFits 

to PubLiC hEaLth 

dr Lembit rägo, Coordinator, Quality assurance 

and safety: medicines, department of 

Essential medicines and Pharmaceutical 

Policies, who, switzerland, gave a comprehensive 

review of the evolution and shifts in the 

regulatory paradigms giving focus to the importance, 

and growing need, of increased harmonization 

among regulators. He commented that 

the environment in which regulators operate 

continues to change, with the development of 

new technologies and globalization of R&D and 

the economic landscape as some of the examples 

given. Dr Rägo suggested that regulators 

should, through harmonization, focus on areas 

and activities where they can add value and 

best contribute to public health. Through the 

formation of effective networks between regulatory 

authorities the sharing of scarce resources 


and elimination of duplicate activities could be 

facilitated. His presentation highlighted the 

harmonization and collaboration initiatives 

WHO supports, such as being a partner in the 

WPRO initiative and WPRO support for harmonization 

in ASEAN. 

rEguLatory work sharing 

in thE middLE East 

dr hajed hashan, Executive director of 

Pharmaceutical Products registration department, 

sFda, saudi arabia, spoke on how 

he saw the region could further improve and 

share ideas going forward. Dr Hashan acknowledged 

the key elements of change that have occurred 

over the period of the last nine MERCs 

and how the environment has evolved. Looking 

forward, he identified areas that offered further 

opportunity for sharing: 

• Harmonization 

• Research 

• Training 

• Transparency 

• Cooperation between regulatory authorities on a 

global level 

During the discussion, Dr Hashan commented 

that it was important to understand that collaboration 

does not mean a decrease in resources. 

Before consolidating, there is a need to 

ensure that there are enough resources to progress 

and maintain collaboration. In addition, 

collaboration should not be viewed as a reflection 

on an inability to do it yourself but an opportunity 

to learn and avoid duplication. 

fa L s i f i e d m e d i c i n e s 

This subject area’s key goal was to emphasize 

and continue to reduce the public health risk 

posed by falsified medicines. The interaction 

between regulatory authorities and industry is 

key in targeting this goal of eradicating falsified 

medicines. This again provided significant debate 

during the conference. Four speakers were 

invited to share their views and experiences on 

this matter: dr Lembit rägo (Coordinator, 

Quality Assurance and Safety: Medicines, Department 

of Essential Medicines and Pharma


ceutical Policies, WHO, Switzerland), dr Colette 

raidy (Head of Inspection Department, 

Ministry of Health, Lebanon), dr ziad nassour 

(President of the Lebanese Order of 

Pharmacists, President of EMROPHARM 

Forum, WHO, Vice President of CIOPF, Lebanon), 

and tracy hassan (Director, Global 

Brand Protection, the Pharmaceutical Companies 

of Johnson and Johnson, USA). All speakers 

emphasized that falsified medicines are a 

growing problem that affects all regions in our 

world and that there is a need to continue risk 

minimization for public health. 

The team of Quality Assurance and Safety of 

Medicines in the department of Essential Medicines 

and Pharmaceutical Policies of the cluster 

of Health Systems and Services located at WHO 

includes also the program for anticounterfeiting 

under the lead of Dr Sabine Kopp, who is 

also executive secretary of the International 

Medicinal Products Anticounterfeiting Taskforce, 

which is hosted by the government of Italy. 

According to Dr Rägo, the anticounterfeiting 

program includes recommendations, policy advice, 

and training to improve quality and transparency 

of regulatory activities to enable a 

more accurate survey of products to be placed 

on the markets by developing global activities 

to combat substandard and falsified medicines. 

During 2008 and 2009, concerns arose that 

the fight against counterfeit or falsified medicines 

might have negative impact on generics, 

and the use of the counterfeit argument for limiting 

free trade, competition, and parallel trade 

as well as the use of the term “counterfeit medicinal 

product” in patents led to disputes due 

to a lack of agreement. The proposal is to 

change the definition from counterfeit to falsified, 

which is a more distinct expression for the 

crime committed against human health (for further 

information see http://www.who.int/medi 

cines/services/counterfeit/eu/). 

Also according to Dr Raidy, the counterfeit or 

falsified products are a major public health risk 

for all communities, and she emphasized that 

the known counterfeit or falsified products 

market amounts to at least $75–200 billion per 

year and that the situation is expected to get 

worse. The production and sale of counterfeit 

or falsified products is on the rise, not only in 

the developing countries, which are facing the 

worst problem, but also in developed countries. 

In this context it needs to be considered that 

unwary consumers are buying counterfeit or 

falsified products over the Internet. According 

to WHO, more than 50% of the medicine 

bought from certain illegal websites has been 

found to be fake. Not only cheaper prices but 

also lack of education and awareness of danger 

on the part of the consumers support this increasing 

market. She emphasized that the circulation 

of counterfeit or falsified products is 

difficult to stop, and she presented tools, guidelines, 

and activities of regulators in Lebanon, 

including cooperation and collaboration between 

ministries of health, customs, and police, 

to combat this increasing trade. 

Counterfeit or falsified products are silent 

killers distributed by criminals, Dr Nassour 

said, and he presented alarming results of falsification 

of medicines, which often cannot be 

detected without diligent laboratory examination, 

and which can cause severe damage to 

public health. He mentioned that there is a major 

conflict between the culture of professionals 

who are responsible for public health and the 

culture of traders, based on greed and profit, 

supply, and demand as well as on promotion 

and consumption. As a measure to enhance 

awareness of the customs, institutions, health 

professionals, pharmacists, distributors, and 

consumers against counterfeit or falsified medicines, 

he and his associates started a great campaign 

all over Lebanon. In summary, Dr Nassour 

encourages more serious sanctions against 

counterfeiting, an active coordination with the 

international authorities (FDA, EMEA, WHO, 

etc), and also a political commitment and a real 

will of world governments to fight counterfeiting. 

First of all patient safety, but also the reputation 

of the product and brand as well as the 

manufacturer are endangered by the market for 

counterfeit or falsified products. According to


Tracy Hassan, it is definitely also the aim of industry 

to use product protection technology, to 

improve the safety and transparency of the supply 

chain, to participate in governmental and 

industry initiatives, and to manage issues as 

they arise. She explained that safe and secure 

supply chain practices in industry are one of 

the steps industry can use to fight against a 

counterfeit or falsified products market: prompt 

incident reporting and management, monitoring 

to identify issues, internally available commercial 

data awareness, distributor compliance, 

and proper transportation and facility security 

as well as anticounterfeit product protection by 

security holograms, labels, stickers, and further 

antitampering measures. 

All speakers emphasized that immediate measures 

by manufacturers, customs, distributors, 

institutions, pharmacists, health professionals, 

and consumers as well as security agencies are 

urgently needed to carry on the fight against 

the increasing market for falsified products. In 

addition, all speakers agreed that suitable education 

for an increased awareness of the public 

worldwide is a mandatory step for improvement 

of the situation. 

s u m m a r y a n d w ay s f o r w a r d 

Some key topics emerged from the conference 

program and the panel debates, which warrant 

further consideration by industry and regulators, 

either through discussions at a local level 

through the industry associations or through 

the development of the Middle East Regulatory 

Workshop in 2012: 

• ICH CTD: GCC member countries have implemented 

CTD and the Arab League has committed 

to implementation by the end of 2013, although 

the legal status of this decision is unclear. This offers 

the opportunity for harmonization across the 

region, not only in format but also in content of 


dossiers for new products. There is also the need to 

consider older products, where focus on upgrading 

Module 3 may be the most pragmatic solution. 

• Pharmacovigilance: legislation and systems have 

been introduced in some markets in the region, 

with a number of consequential requirements on 

companies. Clarifying some confusion over the 

definition of a market authorization holder will 

help companies discharge their responsibilities relating 

to pharmacovigilance. 

• Variations: the adoption of the EU guidelines, including 

the latest simplifications to reduce administrative 

burden on authorities, is also a topic worthy 

of further debate. Classification of different 

types of change is key and could form the basis of a 

training workshop. 

During the conference, the challenge faced by 

authorities on what to do with limited resources 

became apparent. The decisions taken now on 

prioritization will potentially impact future regulatory 

environment in the region. Professor 

Jones encouraged continued dialogue between 

industry and regulatory authorities to progress 

the debate and take action to further improve 

access to safe and efficacious, quality medicines 

to patients in the region. 

Acknowledgments—The authors express sincere 

thanks to the following individuals for their contribution 

in preparing this article, namely: Angelika 

MichaelisGilles, EFPIAMERN Chair, Grünenthal 

GmbH, Germany; Kerstin AhrendtSölter, MERN 

member, Biotest AG, Germany; Sheherazad Aftabroushad, 

MERN member, Eli Lilly, Switzerland; Visda 

Vaghayenegar, MERN member, SanofiAventis, 

France; Amanda Foster, MERN member, GlaxoSmith 

Kline, UK; MohamedRafik Nurmohamed, MERN 

member, Biogen Idec, UK; Nadine Otin, MERN member, 

Cephalon Europe, France; Inas Chehimi, MERN 

member, Genzyme Middle East, UAE. 

Adrian Ball reports no relevant relationships to disclose. Mike Fallows has disclosed that as an employee of AstraZeneca, 

he receives stock shares as part of a reward package.

Review of the 9th Middle East Regulatory Conference - Drug ...

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