Regulatory term:

CTD: The Common Technical Document ( The CTD

triangle.

M4 : The Common Technical Document

The agreement to assemble all the Quality, Safety and Efficacy information in a common format
(called CTD - Common Technical Document ) has revolutionised the regulatory review
processes, led to harmonised electronic submission that, in turn, enabled implementation of good
review practices. For industries, it has eliminated the need to reformat the information for
submission to the different ICH regulatory authorities.

The CTD is organised into five modules. Module 1 is region specific and Modules 2, 3, 4 and 5
are intended to be common for all regions. In July 2003, the CTD became the mandatory format
for new drug applications in the EU and Japan, and the strongly recommended format of choice
for NDAs submitted to the FDA, US.

Pharmaceutical Registration Dossier & Format

Pharmaceutical Dossier is an Important & Critical part of Product Registration process, which is
need to submit in Food & Drug Administration of the concerned Ministry of Health, of
Regulatory Authority.

Different Regulatory Authority published their Standard format according to country Guidelines.

Common Pharmaceutical Dossier which is widely used in the Pharmaceutical Industry are:

CTD Dossier

ACTD Dossier

eCTD Dossier

Country Specific Registration Dossier

Page | 1
CTD Format Dossiers

This Format of Dossier is an Important & widely used Dossier format in most of the country,
This format of any registration application for Marketing Authorization Dossier is submitted to
Food and Drug Authority or Ministry of health or any other equivalent authority along with other
required documents.

SGPRC provide registration file for drug product registration in various countries all over the
world for many Pharmaceutical Company in INDIA & for our International Business Associates.

SGPRC Provides Registration Dossier service in Dossier Compilation, Dossier Preparation &
Dossier Review in accordance to the respective Regulatory Authority Guidelines.

Pharmaceutical Dossier Compilation, Review and writing as per CTD Format

(Common technical Document)

Common Technical Document Consists of the following Modules with the number of the

required Documents.

Module 1 – Administrative Information & Prescribing Information

Module 2 - Common Technical Documents Summaries
Module 3 –Quality
Module 4 – Non Clinical Study Report
Module 5 – Clinical Study Report

CTD Format Dossier is widely used in semi regulated & regulated market like CIS Countries,
Middle East countries, European Union, USA , Australia, African Countries, Canada, Japan, etc

ACTD Format Dossiers

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ACTD Format Dossier is also Described as ASEAN CTD Dossier, ASEAN Common Technical
Dossier (ACTD) provides a common format for the preparation of well-structured Common
Technical Dossier applications for submission in ASEAN regulatory authorities for the
registration of pharmaceuticals for human use. ACTD format significantly reduce the time and
resources needed to compile applications for registration. Regulatory reviews and comunication
with the applicant is facilitated by a standard document of common elements.

This guideline merely demonstrates an appropriate write-up format for acquired data.
However,applicants can modify, if needed, to provide the best possible presentation of the
technical information, in order to facilitate the understanding and evaluation of the results upon
pharmaceutical registration.

Dossier writing and compilation as per ACTD Format.

Asian Common Technical Documents consists of following parts.

Part I – Administrative Data and Product Information

Part II – Quality Documents
Part III – Non Clinical Documents
Part IV – Clinical Documents.

ACTD Format is Asian harmonization for Common technical Documents used in

Asian Countries like Vietnam, Thailand, Singapore, and Malaysia, Philippines

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& in Member States.

eCTD Format Dossier

This format of Registration Dossier is an electronic format for CTD Dossier, Submission in
eCTD format should be in accordance with the current ICH M2 EWG eCTD specification,
Electronic files should be in accordance with the Guidance for Industry on Providing Regulatory
Information in Electronic Format. The eCTD is an interface for the pharmaceutical industry to
transfer regulatory information with various regulatory agencies. The content is based on the
Common Technical Document (CTD) format. It was developed by the International Conference
on Harmonisation (ICH) Multidisciplinary Group 2 Expert Working Group (ICH M2 EWG).

The US FDA and Europe EMEA announced that the eCTD is the preferred format for electronic
submission (eSubmisson) of Drug Dossiers. The drug manufacturer has to submit the drug
dossier in eCTD format.

NeeS format Dossier

Requirements for the submission of Non-eCTD electronic Submissions (NeeS). A separate EU

guidance document covering eCTD submissions, which is regarded as the principal electronic
submission format in EU.

A NeeS format submission can normally be started with any initial, variation or renewal MA
submission.

Page | 4
Once the switch to this electronic format is made it is expected that further applications and
responses relating to the particular medicinal product are submitted in NeeS format. Applicants
can switch from NeeS to eCTD at the start of any new regulatory activity. Applicants should
however not change from eCTD back to NeeS.

There is no requirement to reformat the whole dossier into NeeS format when switching from
paper to NeeS, but this could be done at the applicant’s discretion.
.

Country Specific Format

This format of Registration Dossier is in accordance with the Specific Country Regulatory
Guidelines.

SGPRC help you to compile and write entire dossier of specified modules as per Guidelines
provided by the Government Regulatory Authorities, we also help Pharmaceutical companies to
establish their Document Management and writing system by guiding them draft templates on
BPR, BMR, COA , Standard Testing Procedure, Packing Procedures, and other technical
documents. We can provide these documents as per company requirement. Good for startup
companies or scale up companies.

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Introduction

The Pharmaceutical Inspection Co-operation Scheme (PIC/S) was established in 1995 as an

extension to the Pharmaceutical Inspection Convention (PIC) of 1970

The Pharmaceutical Inspection Co-operation Scheme (PIC/S) is a non-binding, informal co-

operative arrangement between Regulatory Authorities in the field of Good Manufacturing
Practice (GMP) of medicinal products for human or veterinary use. It is open to any Authority
having a comparable GMP inspection system. PIC/S presently comprises 52 Participating
Authorities coming from all over the world (Europe, Africa, America, Asia and Australasia).

PIC/S aims at harmonising inspection procedures worldwide by developing common standards

in the field of GMP and by providing training opportunities to inspectors. It also aims at
facilitating co-operation and networking between competent authorities, regional and
international organisations, thus increasing mutual confidence. This is reflected in PIC/S’
mission which is to lead the international development, implementation and maintenance of
harmonised GMP standards and quality systems of inspectorates in the field of medicinal
products.

This is to be achieved by developing and promoting harmonised GMP standards and guidance
documents; training competent authorities, in particular inspectors; assessing (and reassessing)
inspectorates and facilitating the co-operation and networking for competent authorities and
international organisations.

GM(D)P Harmonisation

The harmonisation of Good Manufacturing Practice (GMP) and more recently of Good
Distribution Practice (GDP) is at the very heart of PIC/S. The development and promotion of
high and harmonised GMP standards and guidance documents has been a key focus since the
start. The reason is obvious: to accept inspection results or have a GMP system equivalent to
other PIC/S Members, you need to rely on common standards.

Training

Training Competent Authorities and in particular, training Inspectors, is an integral and key
activity of PIC/S. The training of GMP Inspectors has been one of PIC/S’ main focal points since
the very beginning. Through this emphasis on training, PIC/S is able to achieve its mission.

A Key Feature of PIC/S

Harmonising GMP requirements through the PIC/S GMP Guide ensures uniform interpretation
and application of GMP, however, focused training of GMP Inspectors is essential to achieve
this goal. For this reason, training of GMP Inspectors is a key priority and activity of PIC/S.

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Recently, the PIC/S training tools, available to Inspectors, have been expanded and activated in
areas such as Good Distribution (GDP) and Good Clinical Practices (GCP).

The variety of PIC/S training tools has progressively developed; starting with an Annual Seminar
alone, before expanding to include the Joint Visits Programme (JVP), the establishment of
Expert Circles in specialised areas and training courses, such as the New Inspector Training
Course and Train the Trainer Course, which were developed in 2011 and 2014 respectively. The
PIC/S Inspectorates' Academy (PIA) was established in 2014 and officially launched in 2016.

Compliance

One of the essential requirements to join PIC/S is that Competent Authorities must have the
arrangements necessary to apply an inspection system comparable to that referred to in this
Scheme and whose requirements and procedures could ensure the proper implementation of the
Scheme and contribute to its effective operation. Being equivalent is not only required for
accession but all the time and duly verified during reassessments. This is why compliance to the
PIC Scheme is one of PIC/S’ most important and critical areas, which needs to be constantly
monitored.

Expert Circles

Expert Circles have been set up by PIC/S to facilitate the discussions and the exchange of
information among Inspectors specialised in a specific area of GMP such as blood, Computerised
Systems, Active Pharmaceutical Ingredients, Quality Risk Management, etc. Expert Circles
meet regularly to develop draft guidance, recommendations, etc. and offer training in their
respective fields of specialisation.

Strategic Development

The Founders of the PIC Convention had a visionary idea - that of creating a free trade market
for pharmaceutical products and facilitating the international trade while ensuring the best
possible protection of patients through high GMP standards. This was to be achieved by the
mutual recognition of GMP inspections - the PIC Convention - and the harmonisation of GMP
standards - the PIC GMP Guide.

Mission & Goals

In 1995, when the Convention’s successful expansion was stopped due to an alleged
incompatibility with European law, the PIC Committee of Officials came with another visionary
idea, which was to create a non-binding platform to exchange GMP-related information and to
further harmonise GMP standards as well as provide GMP training. The PIC Scheme was born.

At its 65th meeting in Geneva on 22-23 April 2002, the PIC/S Committee adopted the following
mission and goals for PIC/S:

Page | 7
“To lead the international development, implementation and maintenance of harmonised GMP
standards and quality systems of inspectorates in the field of medicinal products”

This is to be achieved by:

 Developing and promoting harmonised GMP standards and guidance documents;

 Training competent authorities, in particular Inspectors;
 Assessing (and reassessing) Inspectorates;
 Facilitating the co-operation and networking for competent authorities and international
organisations.

By and large, the overall mission and the way the goals should be achieved are still valid today.
But will it still be the case tomorrow? Visionary, strategic thinking has been the key of PIC/S
success of the past 40 years. This is why strategic development is essential to guarantee PIC/S’
future.

Communication

PIC/S regularly communicates on its activities through press releases, annual reports and - since
the start of millennium - its website. Good communication between Participating Authorities
through PA representatives is one of PIC/S’ recognised benefits, which derives from
Membership. Communication has also become an important tool to promote PIC/S. As a result,
the PIC/S Committee has decided to establish a specific Sub-Committee on Communication.

Budget, Risk & Audit

No organisation can survive without the support of an efficient, administrative structure such as a
Secretariat. But a high-quality Secretariat must be funded. Risk is inherent to most organisations:
whether regulatory, financial or reputational, all risks must be properly assessed through regular
or special audits and the identified risks must be then either eliminated or minimised.

Incoterms

The Incoterms or International Commercial Terms are a series of pre-defined commercial

terms published by the International Chamber of Commerce (ICC) relating to international
commercial law. They are widely used in international commercial transactions or procurement
processes and their use is encouraged by trade councils, courts and international lawyers. [1] A
series of three-letter trade terms related to common contractual sales practices, the Incoterms
rules are intended primarily to clearly communicate the tasks, costs, and risks associated with the
global or international transportation and delivery of goods. Incoterms inform sales contracts
defining respective obligations, costs, and risks involved in the delivery of goods from the seller
to the buyer, but they do not themselves conclude a contract, determine the price payable,
currency or credit terms, govern contract law or define where title to goods transfers.
Page | 8
The Incoterms rules are accepted by governments, legal authorities, and practitioners worldwide
for the interpretation of most commonly used terms in international trade. They are intended to
reduce or remove altogether uncertainties arising from differing interpretation of the rules in
different countries. As such they are regularly incorporated into sales contracts[2] worldwide.

"Incoterms" is a registered trademark of the ICC.

The first work published by the ICC on international trade terms was issued in 1923, with the
first edition known as Incoterms published in 1936. The Incoterms rules were amended in
1953,[3] 1967, 1976, 1980, 1990, and 2000, with the eighth version— Incoterms 2010 [4] —
having been published on January 1, 2011. The ICC has begun consultations on a new revision
of Incoterms, to be called Incoterms 2020.

Incoterms

What are Incoterms

Incoterms - a.k.a. Trade Terms are key elements of international contracts of sale. They tell the
parties what to do with respect to carriage of the goods from buyer to seller, and export & import
clearance. They also explain the division of costs and risks between the parties.

The difference between the 2000 and the 2010 version is the number of Incoterms has been
reduced from 13 to 11. Four Incoterms (DAF, DES, DEQ, DDU) have been replaced by two
new Incoterms (DAT , DAP). The replaced Incoterms DAF, DES and DEQ were not used much
in day to day trading.

At Wim Bosman we support both the Incoterms 2000 as the newly introduced Incoterms 2010.
Please see below an overview of Incoterms and their version.

EXW - ExWorks (2000 and 2010)

This term represents the seller's minimum obligation, since he only has to place the goods at the
disposal of the buyer. The buyer must carry out all tasks of export & import clearance. Carriage
& insurance is to be arranged by the buyer.

FCA - Free Carrier (2000 and 2010)

This term means that the seller delivers the goods, cleared for export, to the carrier nominated by
the buyer at the named place. Seller pays for carriage to the named place.

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FAS - Free Alongside Ship (2000 and 2010)

This term means that the seller delivers when the goods are placed alongside the vessel at the
named port of shipment. The seller is required to clear the goods for export. The buyer has to
bear all costs & risks of loss or damage to the goods from that moment. This term can be used
for sea transport only.

FOB - Free On Board (2000 and 2010)

This term means that the seller delivers when the goods pass the ship's rail at the named port of
shipment. This means the buyer has to bear all costs & risks to the goods from that point. The
seller must clear the goods for export. This term can only be used for sea transport. If the parties
do not intend to deliver the goods across the ship's rail, the FCA term should be used.

CFR - Cost and Freight (2000 and 2010)

This term means the seller delivers when the goods pass the ship's rail in the port of shipment.
Seller must pay the costs & freight necessary to bring the goods to the named port of destination,
BUT the risk of loss or damage, as well as any additional costs due to events occurring after the
time of delivery are transferred from seller to buyer. Seller must clear goods for export. This
term can only be used for sea transport.

CIF - Cost, Insurance, Freight (2000 and 2010)

The seller delivers when the goods pass the ship's rail in the port of shipment. Seller must pay the
cost & freight necessary to bring goods to named port of destination. Risk of loss & damage
same as CFR. Seller also has to procure marine insurance against buyer's risk of loss/damage
during the carriage. Seller must clear the goods for export. This term can only be used for sea
transport.

CIP - Carriage and Insurance Paid (2000 and 2010)

This term is the same as CPT with the exception that the seller also has to procure insurance
against the buyer's risk of loss or damage to the goods during the carriage. This term may be
used for any mode of transportation.

CPT - Carriage Paid To (2000 and 2010)

This term means that the seller delivers the goods to the carrier nominated by him but the seller
must in addition pay the cost of carriage necessary to bring the goods to the named destination.
The buyer bears all costs occurring after the goods have been so delivered. The seller must clear

Page | 10
the goods for export. This term may be used irrespective of the mode of transport (including
multimodal).

DAF - Delivered At Frontier (2000)

This term means that the seller delivers when the goods are placed at the disposal of the buyer on
the arriving means of transport not unloaded, cleared for export but not cleared for import, at the
named point & place at the frontier - but before the customs border of the adjoining country. To
be used when delivering to a land frontier.

DES - Delivered Ex Ship (2000)

Seller delivers when goods are placed at the disposal of the buyer on board the ship, not cleared
for import at the named port of destination. The seller bears all costs & risks in bringing the
goods to the named port before discharging. This term can only be used when the goods are to be
delivered by sea.

DEQ - Delivered Ex Quay (2000)

This terms is the same as DES with the exception that the seller is responsible to place the goods
at the disposal of the buyer, not cleared for import, on the quay (wharf) at the named port of
destination. Seller bears all costs & risks as in DES plus discharging the goods on the quay. This
term can only be used in sea transport.

DDU - Delivered Duty Unpaid (2000)

This term means the seller delivers the goods to the buyer, not cleared for import, and not
unloaded from arriving means of transport at the named place of destination. The seller bears all
costs & risks involved in bringing the goods to the named place other than "duty" (which
includes the responsibility for customs formalities & payment of those formalities, duties &
taxes) for import into the country of destination. Buyer is responsible for payment of all customs
& duties & taxes.

DDP - Delivered Duty Paid (2000 and 2010)

This term represents maximum obligation to the seller. This term should not be used if the seller
is unable to directly or indirectly to obtain the import license. The terms means the same as the
DDU term with the exception that the seller also will bear all costs & risks of carrying out
customs formalities including the payment of duties, taxes & customs fees.

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DAT – Delivered at Terminal (named terminal at port or place of destination) (2010)

Seller pays for carriage to the terminal, except for costs related to import clearance, and assumes
all risks up to the point that the goods are unloaded at the terminal.

DAP - Delivered At Place (named place of destination) (2010)

Seller pays for carriage to the named place, except for costs related to import clearance, and
assumes all risks prior to the point that the goods are ready for unloading by the buyer.

Certificate of pharmaceutical product

From Wikipedia, the free encyclopedia

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The certificate of pharmaceutical product (abbreviated: CPP) is a certificate issued in the

format recommended by the World Health Organization (WHO), which establishes the status of
the pharmaceutical product and of the applicant for this certificate in the exporting country. It is
issued for a single product, because manufacturing arrangements and approved information for
different pharmaceutical forms and strengths can vary.[1]

Documentation

Every country has its own system and requirements in order to register a pharmaceutical or
veterinary product. Although the required documents and procedures vary quite a bit most have
many similar requirements for documents in order to ensure that the product being registered
meet their standards for efficacy, safety and quality. To ensure quality standards are met,
the appropriate regulatory authority in the intended drug market may request documents about
the drug in question such as the COPP, FSC, Complete Registration certificates from other
countries, Product Registration Dossier and others.

Good Manufacturing Practices (GMP)

A good manufacturing practices certificate show that the pharmaceutical manufacturing

company has passed the inspection of the pharmaceutical regulatory body of that country and
meets the standards of good manufacturing practices as stated by the WHO.

Certificate of Analysis (COA)

A certificate of Analysis is the document that shows the testing parameters of a pharmaceutical
product according to the pharmacopeia in which the product was tested to adhere to. The COA
shows each test and their correlating results alongside the results the pharmacopeia allows. An
overall result of whether the pharmaceutical product passes or fails according to the
pharmacopeia is listed at the bottom.

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Certificate of a Pharmaceutical Product (COPP)

The COPP is the legal document that declares a certain manufacturing company is legally
allowed to sell their pharmaceutical product in the country they are producing. When registering
a pharmaceutical product overseas, the government body in charge of approving the application
will usually require a COPP to ensure that the product is being sold as a commercial finished
product in the country that is producing it.

Free Sales Certificate (FSC)

A Free Sales certificate is similar to a COPP where it enables a manufacturing company to list
pharmaceutical products in which they can sell in the local market and internationally. A FSC,
however can list multiple products at the same time.

DOSSIER

A Dossier is required by most ministries in charge of the regulation of importation to ensure the
process the manufacturer uses to produce a pharmaceutical product is an acceptable international
standard. The Product Registration Dossier is a document that describes all the technical data
related to the production, raw materials, standard, stability and quality of the products.The
Dossier describes the origin, testing procedures and quality control of all the active and inactive
pharmaceutical ingredients used in the production including their analysis.

The processing of the raw materials is described in detail including the process controls and the
critical steps of intermediates. A Flow Diagram is typically used to show step by step the process
the raw materials and excipients undergo in order to obtain the final product. The analysis of the
final product is described in detail including the test results according to the pharmacopeia used
for analysis. Full short and long term stability studies are also included to ensure the products
can stand the test of time and the elements.

Periodic Safety Update Reports (PSURs)

A Periodic Safety Update Report is a pharmacovigilance document intended to provide an

evaluation of the risk-benefit balance of a medicinal product at defined time points post-
authorisation. The objective of the PSUR is to present a comprehensive and critical analysis of
the risk-benefit balance of the product taking into account new or emerging safety information in
the context of cumulative information on risk and benefits.
The legal requirements for submission of PSURs are established in Regulation (EU) No
1235/2010, Directive 2010/84/EU and in Commission Implementing Regulation (EU) No
520/2012. The format of PSURs follows the structure described in the Implementing Regulation
Article 35 and Module VII of the Guidelines on Good Pharmacovigilance Practices (GVP)
provides guidance on the preparation, submission and assessment of PSURs. This format is a
legal requirement for both Nationally Authorised Products (NAPs) and Centrally Authorised
Products (CAPs).

Page | 13
Who should submit PSURs?

The 2010 legislation introduces the principle of EU single assessment where a substance is
authorised in more than one Member State. The European Medicines Agency maintains a list of
EU reference dates and frequency of submission of PSURs (EURD list) for active substances
contained in medicines in the EU and is updated on an ongoing basis.

Marketing Authorisation Holders (MAHs) are required to submit PSURs according to the data
lock points published in the EURD list. The legislation introduces derogation for routine PSUR
reporting for certain products. Unless there is a specific condition in the authorisation, or it is
indicated otherwise in the EURD list, routine PSUR reporting is not required for medicinal
products authorised under the following articles of Directive 2001/83/EC:

• Article 10.1 generics

• Article 10.a well-established use
• Article 14 homeopathic medicines
• Article 16a traditional herbal medicines

Further information on GVP and the EURD list may be found on the European Medicines
Agency website. Please note that the EURD list is a living document which will be amended
whenever considered necessary by the PRAC, the CHMP or CMDh in response to the emergence
of relevant new safety information, newly authorised substances and requests received from
MAHs. Substances can be added or removed as appropriate. MAHs should therefore maintain an
awareness of the current status of the list which is reviewed on a monthly basis.

Guidance on PSUR Submission

Mandatory submission of PSURs via the EU PSUR Repository

As of 13th June 2016, it is mandatory for all MAHs to submit PSURs for human medicines
authorised in the EU directly to the PSUR repository. The repository will act as the single point
for all submissions (including responses and supplementary information). This is mandatory for
both centrally authorised and nationally authorised medicinal products whether they follow the
EU single assessment or a purely national assessment procedure. As a consequence, no further
PSUR submissions should be made to the HPRA from this date onwards and the CMDh
document “Requirements on Submissions for Periodic safety update reports (PSUR) to National
Competent Authorities (NCAs) for products authorised via National Procedures, MRP and DCP
(NAPs)” is no longer applicable. PSURs not sent to the PSUR repository are considered as not
submitted and will not fulfil the MAH’s legal obligation to submit PSURs.

All PSURs should be submitted to the PSUR repository using the eSubmission Gateway/Web
Client: http://esubmission.ema.europa.eu/esubmission.html

Information on the repository, guidance on how to register and multimedia tutorials for MAHs
on how to submit a PSUR, as well as on the correct structured electronic formats, can be found

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on EMA’s PSUR repository web pages here:
http://esubmission.ema.europa.eu/psur/psur_repository.html

Further information for MAHs on changes to submission of PSURs for human medicines is
available here: PSUR repository mandatory use: Q&A

Users of the repository should direct any questions on use of the EMA PSUR repository and/or
the eSubmission Gateway/Web Client to the EMA Service Desk portal:
https://servicedesk.ema.europa.eu.

For further information on submission dates, PSUSA procedure number and requirements for
submission of products referred to in articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as
amended please refer to the EURD list.

Detailed guidance on procedural aspects of the EU single assessment is available on the EMA
website: PSURs: questions and answers

A letter of credit (LC), also known as a documentary credit or bankers commercial credit, is
a payment mechanism used in international trade to provide an economic guarantee from a
creditworthy bank to an exporter of goods. A letter of credit is extremely common within
international trade and goods delivery, where the reliability of contracting parties cannot be
readily and easily determined. Its economic effect is to introduce a bank as underwriting the
credit risk of the buyer paying the seller for goods.[1]

Telegraphic Transfer or telex transfer, often abbreviated to TT, is a term used to refer to an
electronic means of transferring funds. A transfer charge is often charged by the sending bank
and in some cases by the receiving bank.

Historically telegraphic transfer meant a cable message from one bank to another in order to
effect the transfer of money. Prior to the existence of electronic payment networks this was often
directly between banks via a telex message.

United Kingdom

The term is now most often used in UK banking and in law[citation needed] to refer to either a
CHAPS transfer for domestic transfers or a SWIFT transfer for international transfers.

The term is also used to describe other electronic funds transfer methods and, incorrectly, low
cost everyday payment methods such as BACS (Bankers' Automated Clearing Services)
payments, Faster Payments Service and SEPA credit transfers. Although the United Kingdom is
part of SEPA with the consequent low costs of intra-SEPA payments, most UK banks charge for

Page | 15
SEPA credit transfers as if they were telegraphic transfers, unlike banks in other non-Eurozone
SEPA countries such as Switzerland and Sweden where SEPA credit transfers are charged at
similar low fees to domestic payments.

Japan

In Japan, "telegraphic transfer" is the industry term for quoting retail exchange rates (larger
quantities are quoted individually), and is divided into three rates, stated in yen, from the point of
view of the quoting bank: [1][2]

 TTM: Telegraphic Transfer Middle rate (mid price)

 TTS: Telegraphic Transfer Selling rate (ask price)
 TTB: Telegraphic Transfer Buying rate (bid price)

The middle rate is the average of the buying and selling rate, and these trade at a fixed bid–offer
spread (in yen). For example, the USD is quoted with a spread of 2 JPY, so if the mid-market
rate is 100 JPY = US$1, the rates are as follows:

 TTS: 101 JPY: bank will charge more than mid price to sell USD
 TTM: 100 JPY: average, bank does not trade at this price
 TTB: 99 JPY: bank will pay less than mid price to buy USD

These rates are published daily by major Japanese banks, and used for accounting and tax
calculations, in addition to retail use.

Singapore

The term "Telegraphic Transfer" is a frequently used term in Singapore to describe cross-border
fund transfers. Other less commonly used terms in Singapore are wire transfer and bank
transfer.[3][4]

 TT: This is the abbreviation sometimes used to imply Telegraphic Transfer

MENA
From Wikipedia, the free encyclopedia

Jump to navigation Jump to search

This article is about the geographic region. For other uses, see Mena (disambiguation).

"WANA" redirects here. For other uses, see Wana (disambiguation).

MENA is an English-language acronym referring to the Middle East and North Africa region.
An alternative for the same group of countries is WANA (West Asia and North Africa). The

Page | 16
term covers an extensive region stretching from Morocco to Iran, including all Mashriq and
Maghreb countries. This toponym is roughly synonymous with the term the Greater Middle East.

The population of the MENA region at its least extent is estimated to be around 381 million
people. This constitutes about 6% of the total world population. The MENA acronym is often
used in academia, military planning, disaster relief, media planning as a broadcast region, and
business writing.[1][2]

Contents

Controversy

Due to the geographic ambiguity and Eurocentric nature of the term "Middle East", some people
prefer use of the terms Arab World, WANA (West Asia and North Africa)[3] or the less
common NAWA (North Africa-West Asia).[4] Both the Arab world[5] and MENA region remain
the most common terms and are used by most organizations, academia, and political entities
flexibly, including those in the region itself. The World Bank,[6] UNDP[7] and even the UNSC[8]
all use both terms.

List of countries

MENA has no standardized definition; different organizations define the region as consisting of
different territories. The following is a list of commonly included countries and
territories.[1][9][10][11]

 Algeria
 Bahrain
 Egypt
 Iran
 Iraq
 Israel
 Jordan
 Kuwait
 Lebanon
 Libya
 Morocco
 Oman
 Palestine
 Qatar
 Sahrawi Arab Democratic Republic*
 Saudi Arabia
 Syria
 Tunisia
 United Arab Emirates

Page | 17
  Yemen

*Non-sovereign territories.

Other countries sometimes counted as part of MENA:

 Afghanistan
 Armenia
 Azerbaijan
 Chad
 Comoros
 Cyprus
 Djibouti
 Eritrea
 Georgia
 Mali
 Mauritania
 Niger
 Pakistan
 Somalia
 Sudan
 Turkey

Economy

See also: Economy of the Middle East

The MENA region has vast reserves of petroleum and natural gas that make it a vital source of
global economic stability. According to the Oil and Gas Journal (January 1, 2009), the MENA
region has 60% of the world's oil reserves (810.98 billion barrels (128.936 km3)) and 45% of the
world's natural gas reserves ( 2,868,886 billion cubic feet (81,237.8 km3) ).[12]

As of 2011, 8 of the 15 OPEC nations are within the MENA region.

Religion

Islam is by far the dominant religion in nearly all of the MENA territories; 91.2% of the
population is Muslim. The Middle East-North Africa region comprises 20 countries and
territories with an estimated Muslim population of 315 million or about 23% of the world's
Muslim population.[13] The term "MENA" is often defined in part in relation to majority Muslim
countries that based on the countries located in the region, although several nations in the region
are not majority Muslim-dominated.[14]

Other terms

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MENAP

From April 2013, the International Monetary Fund started using a new analytical region called
MENAP (Middle East, North Africa, Afghanistan, and Pakistan), which adds Afghanistan and
Pakistan to MENA countries.[15] Now MENAP is prominent economic grouping in IMF
reports.[16][17]

MENAT

The term MENAT has been used to include Turkey in the list of MENA countries.[18][19]

Instability in the region

Due to rich resources, mainly oil and gas, combined with its location between three continents,
(Asia, Africa and Europe), the MENA region has been in conflict since the collapse of the
Ottoman Empire; notably due to the creation of Israel, a Jewish state among Arab and Muslim
countries; Israeli–Palestinian conflict; the Iran–Iraq War; Iran–Saudi Arabia proxy conflict; and
the rise of terrorism. Conflict in the region had come to its highest peak so far in the 21st
century, with incidents such as the U.S. intervention of Iraq in 2003 and subsequent Iraq War
and the rise of ISIS; the Arab Spring, which spread war to throughout the region such as the
Syrian Civil War, Libyan Civil War and Yemeni Civil War.

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