What are intellectual property rights?

Intellectual property rights are the rights given to persons over the creations of
their minds. They usually give the creator an exclusive right over the use of
his/her creation for a certain period of time.

Intellectual property rights are customarily divided into two main
areas:

(i) Copyright and rights related to copyright. back to top
The rights of authors of literary and artistic works (such as books and
other writings, musical compositions, paintings, sculpture, computer
programs and films) are protected by copyright, for a minimum period
of 50 years after the death of the author.
Also protected through copyright and related (sometimes referred to
as neighbouring) rights are the rights of performers (e.g. actors,
singers and musicians), producers of phonograms (sound recordings)
and broadcasting organizations. The main social purpose of protection
of copyright and related rights is to encourage and reward creative
work.

(ii) Industrial property. back to top
Industrial property can usefully be divided into two main areas:
One area can be characterized as the protection of distinctive
signs, in particular trademarks (which distinguish the goods or
services of one undertaking from those of other undertakings)
and geographical indications (which identify a good as
originating in a place where a given characteristic of the good
is essentially attributable to its geographical origin).

The protection of such distinctive signs aims to stimulate and
ensure fair competition and to protect consumers, by enabling
them to make informed choices between various goods and
services. The protection may last indefinitely, provided the
sign in question continues to be distinctive.
Other types of industrial property are protected primarily to
stimulate innovation, design and the creation of technology. In
this category fall inventions (protected by patents), industrial
designs and trade secrets.

The social purpose is to provide protection for the results of
investment in the development of new technology, thus giving
the incentive and means to finance research and development
activities.

A functioning intellectual property regime should also
facilitate the transfer of technology in the form of foreign
direct investment, joint ventures and licensing.

The protection is usually given for a finite term (typically 20
years in the case of patents).
While the basic social objectives of intellectual property protection
are as outlined above, it should also be noted that the exclusive rights
given are generally subject to a number of limitations and exceptions,
aimed at fine-tuning the balance that has to be found between the
legitimate interests of right holders and of users.


rigins: into the rule-based trade system.... back to top
Ideas and knowledge are an increasingly important part of
trade. Most of the value of new medicines and other high
technology products lies in the amount of invention,
innovation, research, design and testing involved. Films,
music recordings, books, computer software and on-line
services are bought and sold because of the information and
creativity they contain, not usually because of the plastic,
metal or paper used to make them. Many products that used
to be traded as low-technology goods or commodities now
contain a higher proportion of invention and design in their
value for example brandnamed clothing or new varieties
of plants.
Creators can be given the right to prevent others from using
their inventions, designs or other creations and to use
that right to negotiate payment in return for others using
them. These are intellectual property rights. They take a
number of forms. For example books, paintings and films
come under copyright; inventions can be patented;
brandnames and product logos can be registered as
trademarks; and so on. Governments and parliaments have
given creators these rights as an incentive to produce ideas
that will benefit society as a whole.
The extent of protection and enforcement of these rights
varied widely around the world; and as intellectual property
became more important in trade, these differences became a
source of tension in international economic relations. New
internationally-agreed trade rules for intellectual property
rights were seen as a way to introduce more order and
predictability, and for disputes to be settled more
systematically.
The Uruguay Round achieved that. The WTOs TRIPS
Agreement is an attempt to narrow the gaps in the way
these rights are protected around the world, and to bring



Types of intellectual property
The areas covered by the
TRIPS Agreement
Copyright and related
rights
Trademarks, including
service marks
Geographical indications
Industrial designs
Patents
Layout-designs
(topographies) of integrated
circuits
Undisclosed information,
including trade secrets
them under common international rules. It establishes
minimum levels of protection that each government has to
give to the intellectual property of fellow WTO members.
In doing so, it strikes a balance between the long term
benefits and possible short term costs to society. Society
benefits in the long term when intellectual property
protection encourages creation and invention, especially
when the period of protection expires and the creations and
inventions enter the public domain. Governments are
allowed to reduce any short term costs through various
exceptions, for example to tackle public health problems.
And, when there are trade disputes over intellectual
property rights, the WTOs dispute settlement system is
now available.
The agreement covers five broad issues:
how basic principles of the trading system and other
international intellectual property agreements should be
applied
how to give adequate protection to intellectual property
rights
how countries should enforce those rights adequately in
their own territories
how to settle disputes on intellectual property between
members of the WTO
special transitional arrangements during the period when
the new system is being introduced.

Basic principles: national treatment, MFN, and balanced
protection back to top
As in GATT and GATS, the starting point of the intellectual
property agreement is basic principles. And as in the two
other agreements, non-discrimination features prominently:
national treatment (treating ones own nationals and
foreigners equally), and most-favoured-nation treatment
(equal treatment for nationals of all trading partners in the
WTO). National treatment is also a key principle in other
intellectual property agreements outside the WTO.
The TRIPS Agreement has an additional important
principle: intellectual property protection should contribute
to technical innovation and the transfer of technology. Both
producers and users should benefit, and economic and
social welfare should be enhanced, the agreement says.

How to protect intellectual property: common ground-rules
back to top
The second part of the TRIPS agreement looks at different
kinds of intellectual property rights and how to protect
them. The purpose is to ensure that adequate standards of
protection exist in all member countries. Here the starting
point is the obligations of the main international agreements
of the World Intellectual Property Organization (WIPO)
that already existed before the WTO was created:
the Paris Convention for the Protection of Industrial
Property (patents, industrial designs, etc)
the Berne Convention for the Protection of Literary and
Artistic Works (copyright).
Some areas are not covered by these conventions. In some
cases, the standards of protection prescribed were thought
inadequate. So the TRIPS agreement adds a significant
number of new or higher standards.

Copyright back to top
The TRIPS agreement ensures that computer programs will
be protected as literary works under the Berne Convention
and outlines how databases should be protected.
It also expands international copyright rules to cover rental
rights. Authors of computer programs and producers of
sound recordings must have the right to prohibit the
commercial rental of their works to the public. A similar
exclusive right applies to films where commercial rental has
led to widespread copying, affecting copyright-owners
potential earnings from their films.
The agreement says performers must also have the right to
prevent unauthorized recording, reproduction and broadcast
of live performances (bootlegging) for no less than 50
years. Producers of sound recordings must have the right to
prevent the unauthorized reproduction of recordings for a
period of 50 years.

Trademarks back to top
The agreement defines what types of signs must be eligible
for protection as trademarks, and what the minimum rights
conferred on their owners must be. It says that service
marks must be protected in the same way as trademarks
used for goods. Marks that have become well-known in a
particular country enjoy additional protection.

Geographical indications back to top
A place name is sometimes used to identify a product. This
geographical indication does not only say where the
product was made. More importantly, it identifies the
products special characteristics, which are the result of the
products origins.
Well-known examples include Champagne, Scotch,
Tequila, and Roquefort cheese. Wine and spirits
makers are particularly concerned about the use of place-
names to identify products, and the TRIPS Agreement
contains special provisions for these products. But the issue
is also important for other types of goods.
Using the place name when the product was made
elsewhere or when it does not have the usual characteristics
can mislead consumers, and it can lead to unfair
competition. The TRIPS Agreement says countries have to
prevent this misuse of place names.
For wines and spirits, the agreement provides higher levels
of protection, i.e. even where there is no danger of the
public being misled.
Some exceptions are allowed, for example if the name is
already protected as a trademark or if it has become a
generic term. For example, cheddar now refers to a
particular type of cheese not necessarily made in Cheddar,
in the UK. But any country wanting to make an exception
for these reasons must be willing to negotiate with the
country which wants to protect the geographical indication
in question.
The agreement provides for further negotiations in the
WTO to establish a multilateral system of notification and
registration of geographical indications for wines. These are
now part of the Doha Development Agenda and they
include spirits. Also debated in the WTO is whether to
negotiate extending this higher level of protection beyond
wines and spirits.

Industrial designs back to top
Under the TRIPS Agreement, industrial designs must be
protected for at least 10 years. Owners of protected designs
must be able to prevent the manufacture, sale or importation
of articles bearing or embodying a design which is a copy
of the protected design.

Patents back to top
The agreement says patent protection must be available for
inventions for at least 20 years. Patent protection must be
available for both products and processes, in almost all
fields of technology. Governments can refuse to issue a
patent for an invention if its commercial exploitation is
prohibited for reasons of public order or morality. They can
also exclude diagnostic, therapeutic and surgical methods,
plants and animals (other than microorganisms), and
biological processes for the production of plants or animals
(other than microbiological processes).
Plant varieties, however, must be protectable by patents or
by a special system (such as the breeders rights provided in
the conventions of UPOV the International Union for the
Protection of New Varieties of Plants).
The agreement describes the minimum rights that a patent
owner must enjoy. But it also allows certain exceptions. A
patent owner could abuse his rights, for example by failing
to supply the product on the market. To deal with that
possibility, the agreement says governments can issue
compulsory licences, allowing a competitor to produce
the product or use the process under licence. But this can
only be done under certain conditions aimed at safeguarding
the legitimate interests of the patent-holder.
If a patent is issued for a production process, then the rights
must extend to the product directly obtained from the
process. Under certain conditions alleged infringers may be
ordered by a court to prove that they have not used the

patented process.
An issue that has arisen recently is how to ensure patent
protection for pharmaceutical products does not prevent
people in poor countries from having access to medicines
while at the same time maintaining the patent systems
role in providing incentives for research and development
into new medicines. Flexibilities such as compulsory
licensing are written into the TRIPS Agreement, but some
governments were unsure of how these would be
interpreted, and how far their right to use them would be
respected.
A large part of this was settled when WTO ministers issued
a special declaration at the Doha Ministerial Conference in
November 2001. They agreed that the TRIPS Agreement
does not and should not prevent members from taking
measures to protect public health. They underscored
countries ability to use the flexibilities that are built into
the TRIPS Agreement. And they agreed to extend
exemptions on pharmaceutical patent protection for least-
developed countries until 2016. On one remaining question,
they assigned further work to the TRIPS Council to sort
out how to provide extra flexibility, so that countries unable
to produce pharmaceuticals domestically can import
patented drugs made under compulsory licensing. A waiver
providing this flexibility was agreed on 30 August 2003.

Integrated circuits layout designs back to top
The basis for protecting integrated circuit designs
(topographies) in the TRIPS agreement is the Washington
Treaty on Intellectual Property in Respect of Integrated
Circuits, which comes under the World Intellectual Property
Organization. This was adopted in 1989 but has not yet
entered into force. The TRIPS agreement adds a number of
provisions: for example, protection must be available for at
least 10 years.

Undisclosed information and trade secrets back to top
Trade secrets and other types of undisclosed information
which have commercial value must be protected against
breach of confidence and other acts contrary to honest
commercial practices. But reasonable steps must have been
taken to keep the information secret. Test data submitted to
governments in order to obtain marketing approval for new
pharmaceutical or agricultural chemicals must also be
protected against unfair commercial use.

Curbing anti-competitive licensing contracts back to top
The owner of a copyright, patent or other form of
intellectual property right can issue a licence for someone
else to produce or copy the protected trademark, work,
invention, design, etc. The agreement recognizes that the
terms of a licensing contract could restrict competition or
impede technology transfer. It says that under certain
conditions, governments have the right to take action to
prevent anti-competitive licensing that abuses intellectual
property rights. It also says governments must be prepared
to consult each other on controlling anti-competitive
licensing.

Enforcement: tough but fair back to top
Having intellectual property laws is not enough. They have
to be enforced. This is covered in Part 3 of TRIPS. The
agreement says governments have to ensure that intellectual
property rights can be enforced under their laws, and that
the penalties for infringement are tough enough to deter
further violations. The procedures must be fair and
equitable, and not unnecessarily complicated or costly.
They should not entail unreasonable time-limits or
unwarranted delays. People involved should be able to ask a
court to review an administrative decision or to appeal a
lower courts ruling.
The agreement describes in some detail how enforcement
should be handled, including rules for obtaining evidence,
provisional measures, injunctions, damages and other
penalties. It says courts should have the right, under certain
conditions, to order the disposal or destruction of pirated or
counterfeit goods. Wilful trademark counterfeiting or
copyright piracy on a commercial scale should be criminal
offences. Governments should make sure that intellectual
property rights owners can receive the assistance of customs
authorities to prevent imports of counterfeit and pirated
goods.

Technology transfer back to top
Developing countries in particular, see technology transfer
as part of the bargain in which they have agreed to protect
intellectual property rights. The TRIPS Agreement includes
a number of provisions on this. For example, it requires
developed countries governments to provide incentives for
their companies to transfer technology to least-developed
countries.

Transition arrangements: 1, 5 or 11 years or more
back to top
When the WTO agreements took effect on 1 January 1995,
developed countries were given one year to ensure that their
laws and practices conform with the TRIPS agreement.
Developing countries and (under certain conditions)
transition economies were given five years, until 2000.
Least-developed countries had 11 years, until 2006 now
extended to 2013 in general, and to 2016 for pharmaceutical
patents and undisclosed information.
If a developing country did not provide product patent
protection in a particular area of technology when the
TRIPS Agreement became applicable to it (1 January
2000), it had up to five additional years to introduce the
protection. But for pharmaceutical and agricultural
chemical products, the country had to accept the filing of
patent applications from the beginning of the transitional
period (i.e. 1 January 1995), though the patent did not need
to be granted until the end of this period. If the government
allowed the relevant pharmaceutical or agricultural
chemical to be marketed during the transition period, it had
to subject to certain conditions provide an exclusive
marketing right for the product for five years, or until a
product patent was granted, whichever was shorter.
Subject to certain exceptions, the general rule is that
obligations in the agreement apply to intellectual property
rights that existed at the end of a countrys transition period
as well as to new ones.



NDA means New Drug Application. This application is available at the Food and Drug
Administration (FDA).

When the sponsor of a new drug believes that enough evidence on the drug's safety and
effectiveness has been obtained to meet the FDA's requirements for marketing approval, the
sponsor submits to the FDA a new drug application (NDA).

In other words, when a pharmaceutical company creates a new drug, the company must
contact the FDA and demonstrate that the new drug has a particular quality and that the drug
is safe and effective. In this case, the pharmaceutical company will have to fill out a new drug
application (NDA). If the NDA is approved, then the product may be marketed in the United
States.

The application must contain data from specific technical viewpoints for review. The review
is a comprehensive analysis of clinical trial data and other information prepared by the FDA
drug application reviewers. A review is divided into sections on medical analysis, chemistry,
clinical pharmacology, biopharmaceutics, pharmacology, statistics, and microbiology.

For internal tracking purposes, all NDA applications are assigned an NDA number. The NDA
number is a six-digit number assigned by the FDA staff to each application for approval to
market a new drug in the United States. A drug can have more than one application number if
it has different dosage forms or routes of administration.

ANDA means Abbreviated New Drug Application. This application is available at the Food
and Drug Administration (FDA).

An abbreviated new drug application (ANDA) contains data that, when submitted to the
FDA, provides for the review and ultimate approval of a generic drug product. Generic drug
applications are called "abbreviated" because they are not required to include preclinical
(animal) and clinical (human) data to establish safety and effectiveness.

Instead, a generic applicant must scientifically demonstrate that its product is bioequivalent
(i.e., performs in the same manner as the original drug). Once approved, an applicant may
manufacture and market the generic drug product to provide a safe, effective, low cost
alternative to the public.

For internal tracking purposes, all ANDA applications are assigned an ANDA number. The
ANDA number is a six-digit number assigned by the FDA staff to each application for
approval to market a generic drug in the United States.

A generic drug must be the same as the brand-name drug in dosage, safety, strength, how it is
taken, quality, performance, and intended use. Before approving a generic drug product, the
FDA requires many rigorous tests and procedures to assure that the generic drug can be
substituted for the brand-name drug. The FDA bases evaluations of substitutability or
"therapeutic equivalence" of generic drugs on scientific evaluations.


SUPAC
The acronym "SUPAC" stands for "Scale-Up and Post-Approval Changes". It refers to the
FDA-recommended testing and filing actions to be taken by a pharmaceutical firm when
it changes the manufacturing processes of a drug product that has been approved via a
New Drug Application (NDA), an Abbreviated New Drug Application (ANDA), or an
Abbreviated Antibiotic Drug Application (AADA). The Agency has provided its
recommendations to industry in the form of Guidances.
As you may be aware, 21 CFR 314.70 already provides instructions for how changes to
approved manufacturing process should be reported to the Agency. Specifically,
depending on the magnitude of the change and the possibility that the change could
negatively affect the product, the Code provides that notification should be accomplished
in one of three ways:
1. Via a supplement that requires approval by the FDA prior to implementation of
the change;
2. Via a supplement that does not require approval by the FDA prior to
implementation of the change ("changes being effected");
3. Via an annual report.
Unfortunately, the instructions indicating which type of changes fall into what notification
category can be broadly interpreted and are sometimes difficult to follow. Luckily, the
regulations [21 CFR 314.70(a)] also indicate that less burdensome routes of notification
may be followed if those routes are published in the Federal Register (FR). That is the
main purpose of the SUPAC Guidances - to provide industry with clear, streamlined (i.e.,
"less burdensome") ways to test and report manufacturing changes. (Note: As required
by 21 CFR 314.70(a), the documents are issued via the FR.)
Why do the SUPAC Guidances offer an advantage over the regulations?
The documents are specific for particular dosage forms. This approach was taken
since some product types are more complicated than others, and as such, will
likely require more complicated controls. To date, two Guidances have been
finalized. They are:
Guidance for Industry: Immediate Release Solid Oral Dosage Forms---
Scale-Up and Post-Approval Changes: Chemistry, Manufacturing and
Controls, In Vitro Dissolution Testing, and In Vivo Bioequivalence
Documentation (November 1995)
Guidance for Industry: Nonsterile Semisolid Dosage Forms---Scale-Up and
Post-Approval Changes: Chemistry, Manufacturing and Controls; In Vitro
Dissolution Testing and In Vivo Bioequivalence Documentation (May 1997)
In addition, SUPAC documents covering other dosage forms (e.g., extended-
release products, transdermals, parenteral solutions), as well as a related
document(s) for bulk active substances, are at various stages of development.
The FDA and industry have been working very closely to prepare these
documents. Industry supplies its input at meetings and workshops as well as
through written comments.
Although these SUPAC documents are not regulations, the FDA is working to ensure that
the Guidances are as consistently interpreted and applied by both the Agency and
industry as possible. To this end, the Agency has undertaken a rather comprehensive
training program, providing in-house training for its personnel and public workshops for
others. Furthermore, although the main thrust of the training is provided at the time a
Guidance is issued, the Agency has been diligent in ensuring that subsequent, ongoing
interpretation and application of the recommendations remain consistent. In fact, as
recent as February 1997, the FDA issued two documents discussing how to properly
utilize the SUPAC-IR Guidance for Industry (issued November 1995). These documents
are:
Manufacturing Equipment Addendum to the Guidance for Industry for Scale-Up
and Post Approval Changes: Immediate Release Products (SUPAC-IR), Draft
Guidance for Industry. Released on February 3, 1997.
Letter to industry from Dr. Roger L. Williams, Deputy Center Director for
Pharmaceutical Science, CDER, dated February 18, 1997. This letter discussed
how industry should interpret stand alone packaging operation site changes and
stand alone analytical site changes based upon the Agency's re-assessment of
these issues. In addition, it provided the answers to significant questions
frequently asked by industry.
Finally, you asked how these Guidances affect you and your company, specifically. That
depends on what types of products you manufacture, and your job responsibilities in the
company. If you are involved in regulatory affairs submission work, scale-up activities,
process validation, or analytical testing, you may be affected, assuming your company
manufactures immediate release oral dosage forms and nonsterile semisolid dosage
forms. (As indicated above, only these two types of products are currently covered by
SUPAC Guidances.) If you manufacture another product type, SUPAC won't affect you
now; your company must still interpret and follow 21 CFR 314.70. But even if that is the
case, keep an eye out for future SUPAC Guidances that could affect your product -- they
may be coming soon.

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.





he government on Thursday notified the new drug policy that aims at bringing more medicines
under price control.

The National Pharmaceutical Pricing Policy (NPPP) 2012, which was cleared by the government
in November, would bring 348 essential drugs under price control.

"The NPPP-2012 approved by the Cabinet on November 22 , 2012 has been notified on
December 7, 2012," Minister of State for Chemicals and Fertilisers Srikant Kumar Jena said in a
written reply in Lok Sabha.

The outgoing drug policy of 1994, which covers 74 bulk drugs, was implemented through Drugs
Price Control Order (DPCO) 1995.

"Based on the same, a new DPCO (Drugs Price Control Order) shall be prepared, notified," he
added.

Price control over drugs was first introduced in the country in the aftermath of the Chinese
aggression by Drugs (Display of Prices) Order 1962 and the Drugs (Control of Prices) Order
1963.

In another reply, Jena said the National Pharmaceuticals Pricing Authority (NPPA) has
requested the Department of Pharmaceuticals for amendment in 'form IV' of DPCO, 1995,
"which will enable them to seek additional information from the importers of drugs than what is
prescribed under DPCO, 1995."


In an earlier post (here) we had blogged about the National Pharmaceutical Policy 2011 and
its essential features. The last post left off at AIDANs (All India Drug Action Network) PIL
(Public Interest Litigation) and the Supreme Courts (SC) observations that the government
should ensure that the prices of essential drugs reduce rather than escalate. During the
hearing of this PIL the SC recently directed the Government to expedite the notification of
the policy. It was notified on 7 December 2012. The full policy can be found here.

The National Pharmaceuticals Pricing Policy, 2012 will replace the Drug Policy of 1994 and
is intended to be a continuation of the 1994 Policy.


Key points in the policy are:

The ceiling price of drugs will be fixed by adopting simple average price of all brands
having a market share more than or equal to 1% of the total market turnover of that
medicine. The ceiling price would be fixed on the basis of dosage per tablet, capsule
standard injection volume. This approach is different from the weighted average price
of top brands which was a severely criticised feature of the earlier policy. Experts
believed that the weighted average calculation method would have driven up prices of
essential drugs rather than reduced them.
Imported drugs have been brought within the purview of the policy for the first time.
Drugs patented under the Indian Patents Act, 1970 and which have been made as a
result of indigenous products or process have been exempted from price control for a
period of five years. Further, a formulation involving a new delivery system
developed through indigenous R&D would be eligible for exemption from price
control for a period of 5 years from the date of its market approval in India. This
could mean that some essential medicines will be kept outside the ambit of price
control. However on the face of it, it seems to have been brought in to incentivise
investment by pharma companies.
One of the fears was that since the new policy introduces price controls at the
formulation stage manufactures could easily bypass price control by combining the
essential drug with another drug or a non-essential drug however the policy addresses
this problem by stating that in such cases manufacturers shall be required to seek price
approval from the Government before launching the new drug.
Prices of non price control drugs will also be regulated to a certain extent, the policy
states that the Government will ensure that their prices are not raised by more than
10% in a year.
There is still no final decision of the status of patented drugs. Their prices will be
decided by a separate committee.
Reaction from the Industry

The policy seems to have been received with mixed feelings. Neither the industry not the
activists seem completely happy with it.

Most feel that the recent changes to the calculation of prices will definitely bring
down prices of drugs but will severely hit the larger players (who may have to take a
hit of about 15%-20% in revenues) in the market which could in turn effect
investment in the sector. (However in this article available on Pharmabiz here,
P.A.Francis argues why he thinks this is an industry friendly policy after all).
One view from the industry seems quite favourable to the policy, Shakti
Chakraborthy, the President of Lupin Ltd Group while commenting on the policy
stated, It is a good thing that the government has chosen to adopt a market-based
mechanism as against a cost-based mechanism, thus protecting industry interest to a
large extent as also ensuring that drugs reach patients in a cost-effective manner."
The main bone of contention for the activists seems to be the governments decision
to opt for market based pricing rather than cost based pricing. They feel that this
method will almost certainly lead to an overall rise in prices.

The SC is expected to examine the policy and hear further contentions based on AIDANs
PIL in the second week of January. This seems to be a policy whose full effects will probably
be clear only once it is implemented.












HISTORY OF ICH

The Need to Harmonise
The realisation that it was important to have an independent evaluation of medicinal products
before they are allowed on the market was reached at different times in different regions.
However in many cases the realisation was driven by tragedies, such as that with thalidomide
in Europe in the 1960s.
For most countries, whether or not they had initiated product registration controls earlier, the
1960s and 1970s saw a rapid increase in laws, regulations and guidelines for reporting and
evaluating the data on safety, quality and efficacy of new medicinal products. The industry, at
the time, was becoming more international and seeking new global markets, however the
divergence in technical requirements from country to country was such that industry found it
necessary to duplicate many time-consuming and expensive test procedures, in order to
market new products, internationally.
The urgent need to rationalise and harmonise regulation was impelled by concerns over rising
costs of health care, escalation of the cost of R&D and the need to meet the public
expectation that there should be a minimum of delay in making safe and efficacious new
treatments available to patients in need.
Initiation of ICH
Harmonisation of regulatory requirements was pioneered by the European Community (EC),
in the 1980s, as the EC (now the European Union) moved towards the development of a
single market for pharmaceuticals. The success achieved in Europe demonstrated that
harmonisation was feasible. At the same time there were bilateral discussions between
Europe, Japan and the US on possibilities for harmonisation. It was, however, at the WHO
Conference of Drug Regulatory Authorities (ICDRA), in Paris, in 1989, that specific plans
for action began to materialise. Soon afterwards, the authorities approached IFPMA to
discuss a joint regulatory-industry initiative on international harmonisation, and ICH was
conceived.
The birth of ICH took place at a meeting in April 1990, hosted by EFPIA in Brussels.
Representatives of the regulatory agencies and industry associations of Europe, Japan and the
US met, primarily, to plan an International Conference but the meeting also discussed the
wider implications and terms of reference of ICH.
At the first ICH Steering Committee (SC) meeting of ICH the Terms of Reference were
agreed and it was decided that the Topics selected for harmonisation would be divided into
Safety, Quality and Efficacy to reflect the three criteria which are the basis for approving and
authorising new medicinal products.

The Evolution of ICH
For two decades the ICH process has achieved much success. This success is attributed not
only to a process of scientific consensus developed between industry and regulatory experts,
but also to the commitment of the regulatory parties to implement the ICH Tripartite
Harmonised Guidelines and recommendations.
Since ICH's inception in 1990, the ICH process has gradually evolved. ICH's first decade saw
significant progress in the development of Tripartite ICH Guidelines on Safety, Quality and
Efficacy topics. Work was also undertaken on a number of important multidisciplinary topics,
which included MedDRA (Medical Dictionary for Regulatory Activities) and the CTD
(Common Technical Document). As ICH started into a new millennium, the need to expand
communication and dissemination of information on ICH Guidelines with non-ICH regions
became a key focus. Attention was also directed towards facilitating the implementation of
ICH Guidelines in ICH's own regions.
Throughout the second decade the development of ICH Guidelines continued, but with more
attention given to the need to maintain already existing Guidelines as science and technology
continued to evolve. The need to leverage with other organisations was also acknowledged,
particularly for the development of electronic standards. The SC recognised the benefits
afforded by collaboration with Standards Development Organisations, not only from the
perspective of having a larger available pool of technical expertise, but also the opportunity
to progress ICH standards as global standards.
Entering into its third decade of activity, ICH's attention is directed towards extending the
benefits of harmonisation beyond the ICH regions. Training, as well as active participation of
non-ICH regions in guideline development, are seen as key in this effort.
Guidelines
The ICH topics are divided into four categories and ICH topic codes are assigned according
to these categories.

Quality Guidelines
Harmonisation achievements in the Quality area include pivotal milestones such as the
conduct of stability studies, defining relevant thresholds for impurities testing and a more
flexible approach to pharmaceutical quality based on Good Manufacturing Practice (GMP)
risk management.
Safety Guidelines
ICH has produced a comprehensive set of safety Guidelines to uncover potential risks like
carcinogenicity, genotoxicity and reprotoxicity. A recent breakthrough has been a non-
clinical testing strategy for assessing the QT interval prolongation liability: the single most
important cause of drug withdrawals in recent years.

Efficacy Guidelines
The work carried out by ICH under the Efficacy heading is concerned with the design,
conduct, safety and reporting of clinical trials. It also covers novel types of medicines derived
from biotechnological processes and the use of pharmacogenetics/genomics techniques to
produce better targeted medicines.

Multidisciplinary Guidelines
Those are the cross-cutting topics which do not fit uniquely into one of the Quality, Safety
and Efficacy categories. It includes the ICH medical terminology (MedDRA), the Common
Technical Document (CTD) and the development of Electronic Standards for the Transfer of
Regulatory Information (ESTRI).
New Codification as per November 2005
In November 2005, the ICH Steering Committee adopted a new codification system for ICH
Guidelines. The purpose of this new codification is to ensure that the numbering / coding of
ICH Guidelines is more logical, consistent and clear. Because the new system applies to
existing as well as new ICH Guidelines a history box has been added to the beginning of all
Guidelines to explain how the Guideline was developed and what is the latest version.
With the new codification revisions to an ICH Guideline are shown as (R1), (R2), (R3)
depending on the number of revisions. Annexes or Addenda to Guidelines have now been
incorporated into the core Guidelines and are indicated as revisions to the core Guideline
(e.g., R1).
For implementation reasons, the Regulatory Authorities working within the ICH Regions
(European Commission, Food and Drug Administration and Ministry of Health, Labor and
Welfare) may not change the codification retrospectively.










U.S. FDA Drug Establishment Registration
and Listing Requirements
Owners or operators of all drug establishments, not exempt under section 510(g) of the Food,
Drug, and Cosmetic Act (Act), that engage in the manufacture, preparation, propagation,
compounding, or processing of a drug or drugs shall register and submit a list of every drug
in commercial distribution.

Manufacturing or processing means the manufacture, preparation, propagation,
compounding, or processing of a drug or drugs as used in section 510 of the Act and is the
making by chemical, physical, biological, or other procedures of any articles that meet the
definition of drugs in section 201(g) of the Act. The term includes manipulation, sampling,
testing, or control procedures applied to the final product or to any part of the process.

The term "drug" means (A) articles recognized in the official United States Pharmacopoeia,
official Homoeopathic Pharmacopoeia of the United States, or official National Formulary, or
any supplement to any of them; and (B) articles intended for use in the diagnosis, cure,
mitigation, treatment, or prevention of disease in man or other animals; and (C) articles (other
than food) intended to affect the structure or any function of the body of man or other
animals; and (D) articles intended for use as a component of any article specified in clause
(A), (B), or (C).

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Active Pharmaceutical Ingredient (API) Registration API Examples
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An Active Pharmaceutical Ingredient is any substance or mixture of substances indended to
be used in the manufacture of a drug (medicinal) product and that, when used in the
production of a drug, becomes an active ingredient of the drug product. Such substances are
intended to furnish pharmacological activity or other direct effect in the diagnosis, cure,
mitigation, treatment, or prevention of disease or to affec the structure or function of the
body. For assistance with U.S. FDA Active Pharmaceutical Ingredient registration and listing
requirements, simply click the Active Pharmaceutical Ingredient Certificate shown on the
left.



Drug Intermediates Establishment Registration
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Drug Intermediates are materials produced during the steps in the synthesis of an Active
Pharmaceutical Ingredient (API) that must undergo further molecular change or processing
before becoming an API. For assistance with U.S. FDA Drug Intermediate registration and
listing requirements, simply click the Drug Intermediate Certificate shown on the left.

Prescription Drug Establishment Registration
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A Prescription Drug is a human drug that is not safe for use except under the supervision of
licensed medical practitioner. For assistance with U.S. FDA Prescription Drug registration
and listing requirements, simply click the Prescription Drug Certificate shown on the left.
Over the Counter Drug (OTC) Establishment Registration
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An Over-the-Counter Drug is a human drug that is safe and effective for use without
prescription by a licensed medical practitioner. For assistance with U.S. FDA Over-the-
Counter Drug registration and listing requirements, simply click the Over-the-Counter Drug
Certificate shown on the left.