An overview of the US regulatory system

for OTC products

4
Author
Erin Oliver, Director, Regulatory Afairs, GlaxoSmithKline
Consumer Healthcare.
Keywords
Over-the-counter medicine (OTC); US FDA; Federal Trade
Commission (FTC); Monograph; New drug application (NDA);
Prescription-to-OTC switch; Labelling; Promotion.
Abstract
Over-the-counter medicines (OTCs) are increasingly important to
the US healthcare system, where many of todays OTC products
were only available by prescription just a few years ago. By
leveraging lower-cost OTCs and the reduced costs associated with
fewer physician visits, the OTC segment delivers billions of dollars
of value to the US healthcare system annually. OTCs reach the US
market via two regulatory pathways: the OTC monograph system
and the new drug application (NDA) process. The OTC monograph
provides a rapid route to entry for qualifying products, since
pre-marketing approval is not required for conforming products.
Products marketed via the NDA route require FDA approval prior
to marketing, but may be entitled to exclusivity. The "general sales"
status of OTCs in the US expands access to important medications
that consumers can use to manage their health and wellbeing. By
understanding the regulatory framework and requirements for
each class of products, regulatory professionals can better lead
innovation in this exciting area of healthcare.
Introduction
It is widely recognised that non-prescription medicines (also referred
to as over-the-counter drugs or OTCs) play an increasingly vital role
in the US healthcare system.
1
The benefts to the individual consumer
are well known in terms of increased access and afordability. US
census data in 2011 indicated more than 48 million Americans were
uninsured, representing a signifcant population of users who
may rely heavily on OTCs to manage their healthcare needs.
2
By
leveraging the lower cost of OTC medicines and the reduced costs
associated with fewer physician visits (insured), emergency room
visits (uninsured), and medical staf, the OTC segment delivers billions
of dollars of value to the US healthcare system annually.
3,4
The premise of self-medication is that for certain indications it is
possible or even preferable for consumers to manage their health
through the use of nonprescription medicines; consumers around
the world rely on OTCs for the treatment and prevention of a variety
of common conditions such as headache, cold and fu, allergy,
heartburn and dermatitis.
Because OTCs are used directly by consumers they must have a
wide margin of safety; the following are some typical characteristics
of OTC products:
l The product can be safely used without a prescription based on a
long history of use
l Consumers can appropriately self-select (or de-select) the product
based on the OTC label, supported by label user testing
l Potential for misuse or abuse of the product is low
l The benefts of using the product as OTC clearly outweigh the risks.
OTCs in the US
The US subscribes to a two-tier drug class system comprised of
prescription and non-prescription drugs (OTCs).
5,6
The US regulatory
system mandates that drugs be available without a prescription unless
certain circumstances require dispensing by a licensed practitioner.
The two-class distribution system is relatively unique in the global
marketplace. Many markets subdivide non-prescription use into
diferent categories depending on the degree of intervention considered
necessary for safe use, such as pharmacist-only, pharmacy-only or
general sales list (GSL). Additionally, when products are switched from
prescription to non-prescription status, many markets will frst require
pharmacist intervention or location within a pharmacy for a period of
time before the product can be considered for direct consumer access.
In contrast and with few exceptions, all OTC medicines in the US are
available in a variety of retail outlets, such as grocery stores, discount
department stores, convenience stores, mass merchandisers and
pharmacies. With more than 750,000 retail establishments nationwide,
consumers enjoy direct and ready access to important OTC medicines.
3

How the FDA regulates OTC drugs
In general, regulations applicable to prescription drugs also apply
to OTC drugs.
7
Regulations relating to manufacturing, testing,
facility registration and inspection, clinical trials, importation, safety
monitoring and risk management apply equally to both classifcations.
There are hundreds of thousands of marketed OTC drug products
in the US, representative of approximately 800 active ingredients
spanning 80 therapeutic classes of drugs.
8
It would be an impossible
and impractical task for the FDA to review each product individually;
therefore the FDA has devised two distinct pathways for the development
of OTC drugs. The OTC monograph system considers well-established
ingredients by therapeutic class (eg, analgesic, antacid). Products that fall
outside this system are considered new drugs and are assessed on an
individual basis through the new drug application (NDA) process.
OTC monograph system for well-established ingredients
The OTC monograph system was set up in 1972 with the FDAs OTC
Drug Review, an ongoing process by which the safety and efcacy of
OTC ingredients is assessed. An expert advisory panel reviews data
relating to claims and active ingredients for diferent therapeutic
Regulatory Rapporteur Vol 10, No 3, March 2013 www.topra.org
Focus OTC medicines
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www.topra.org Regulatory Rapporteur Vol 10, No 3, March 2013
Focus OTC medicines
classes. The panel recommendations become mandated in an ofcial
OTC Monograph through a three-step public rule-making process:
9,10
Step 1: Panel reports are published in the Federal Register as
Advance Notice of Proposed Rulemaking (ANPR). The ANPR
provides preliminary assignments of ingredients in terms of safety
and efcacy:
l Category I Generally recognised as safe and efective (GRASE)
l Category II Not GRASE
l Category III Insufcient data to determine safety and/or efcacy.
Step 2: Following FDA review and public comment, a tentative
fnal monograph (TFM) is issued by the FDA proposing approved
ingredients, uses, doses, required warnings and appropriate claims.
TFMs are in place for virtually all categories of OTC drugs.
Step 3: Publication of a fnal monograph (FM) setting forth allowable
claims, labelling and active ingredients for OTC drugs in each class.
The FM will appear in the Federal Register and be refected within
21CFR Part330 which lays out the general conditions by which OTCs
are generally recognised as safe, efective and not misbranded.
Drugs marketed in accordance with a fnal monograph can go
directly to market and do not require FDA approval of a marketing
application. The OTC monograph system is commercially advantageous
as it enables rapid entry of conforming products to the marketplace.
Industry or another interested party can propose changes to the
monograph (eg, new ingredient or new indication) through two
mechanisms the Citizen Petition (CP) or the Time and Extent
Application (TEA)
11
process. Both are public processes without
statutory timeframes for complete response, so these proceedings can
be quite lengthy. OTC monographs can also be amended by the FDA
as new information becomes available (eg, emerging safety issues that
require new labelling).
OTC drugs which fall outside the scope of a monograph by virtue
of ingredient, dose, indications, etc, are considered to be new drugs
subject to the NDA process.
NDA process for new drug products
For those drugs requiring an NDA either as a direct-to-OTC product or
a drug switched from prescription (Rx) to OTC status the content and
format of the application is similar to the requirements for prescription
drugs.
12
Companies must submit an NDA to the FDA supporting:
l Safety and efcacy:
l Typically nonclinical (preclinical) safety is well supported for
OTC ingredients; however, modifed active ingredients or novel
excipients may require additional support
l Clinical data support use of the product in line with labelled use.
Clinical trials demonstrating safe use in an OTC environment
(Actual Use Trials) may be required.
Table 1: Required elements of US NDAs to support the OTC label.
Criteria Requirements Objective
Safety and efcacy data Pivotal clinical data (may be from Rx drug for switch products);
additional studies may be required if proposed OTC dose or
indication difer.
Adequate patient exposure in both time and extent to address
any potential FDA safety concerns.
Support beneftrisk in OTC environment.
Proposed labelling Label is directed to the consumer with words that are easily
understood. Follows standard format of OTC Drug Facts: active
ingredients, purpose, use (indication), specifc warnings, directions
and inactive ingredients.
Provides information that allows
consumers to determine whether the drug
is appropriate for their condition, how it
should be used, and clearly communicates
safety considerations.
Label comprehension A series of consumer research studies in which individuals are
asked to read the label and answer questions to test their ability
to read and comprehend the labels key messages. Requires
identifcation of key communication objectives and prospectively
defned endpoints and success rates. No drug is administered.
To assess understanding of major
communication objectives by demonstrating
that consumers can read and comprehend
the information which details the safe and
efective use of the OTC product.
Self-selection Consumer research studies in which individuals are provided
with the label and asked questions to determine whether the
drug is appropriate for them to use. Requires identifcation of key
communication objectives and prospectively defned endpoints
and success rates. No drug is administered.
To assess the consumers likely behaviour
by demonstrating appropriate selection
and deselection based on labelling which
clearly communicates who should or
should not use the product.
Actual use trial An open label study conducted under simulated OTC conditions
in which subjects are provided with the drug to determine their
ability to follow the labels directions for use, warnings, etc. In this
type of trial, the consumer can purchase the drug, take it home
and use it without physician supervision.
To assess safety in a real-world setting
by demonstration that consumers
can correctly self-select and use the
product appropriately in the absence of
intervention by a healthcare provider.
6
Regulatory Rapporteur Vol 10, No 3, March 2013 www.topra.org
Focus OTC medicines
l Benefts outweigh the risks: Clinical data support use of the
product with appropriate label warnings and precautions that can
be understood by the consumer, with low potential for severe side
efects, misuse or abuse
l Quality of the product: Data support ingredients, formulation,
specifcations and test methods, manufacturing process, stability,
shelf-life, packaging and production site and certifcation that the
product is made in line with good manufacturing practices (GMPs).
The format of the application is consistent eCTD requirements;
organised into fve modules and submitted electronically in
conformance with standards for electronic submissions.
Labelling and the role of consumer studies
The labelling is a critical element of the OTC application and the FDA
requires specifc types of studies to demonstrate that the consumer
can use the product safely and efectively in an OTC environment
without a doctors supervision. Three types of consumer research
studies are typically conducted to predict consumer behaviour to an
OTC drug: label comprehension, self-selection, and actual use studies
(see Table1).
1316

Label development is an iterative process and the data collected
from label comprehension and self-selection studies are used
to inform the fnal proposed labelling. Where required, this fnal
proposed labelling is tested under actual use conditions to provide
direct evidence of safety in an OTC environment.
In cases where new clinical data are required to support product
approval, companies may be entitled to three years of marketing
exclusivity.
PDUFA fees enabling efcient and efective drug review
The Prescription Drug User Fee Act of 1992 (PDUFA) has became a
cornerstone of modern FDA drug review. PDUFA was enacted to
enable the FDA to collect fees from industry to facilitate the drug
review process by providing funding for increased FDA stafng to
enable shorter review times.
17
FDA performance goals provide greater
transparency, quality and predictability to the drug review process.
There are three types of user fees applicable to application drug
products: fees associated with the review of the application itself,
fees associated with the named application product and fees for the
establishments where it is manufactured. The specifc user fees are
established on a yearly basis based on infation rates and anticipated FDA
workload. Figure1 shows that, over time, the FDAs user fees particularly
those tied to application review have increased substantially.
18
For
example, at its inception in 1992, the user fee for review of a new
application requiring clinical data was US$100,000. In fscal year 2013,
this fee is US$1,958,800. Thus OTC drug manufacturers must build fling
costs into their innovation pipelines, as new product introductions or line
extensions (new claims or indications) may require signifcant fees.
Expanding access to OTCs through Rx to OTC switch
The process of Rx to OTC switch has contributed signifcantly to
the health and wellbeing of consumers, with more than 700 OTC
products on the market today using ingredients or dosages available
only by prescription less than 30 years ago.
19
Table 2 shows a variety
of OTC indications made available through this process.
20

Historically, OTCs have been geared toward symptomatic relief
and short-term use; however, a number of the switches noted in
Table2 have been paradigm-busters:
l Approved for long-term use and non-episodic treatment
l Approved with PhaseIV commitments such as limited distribution
and age verifcation to manage risk in an OTC environment
l Provided supplemental information beyond the traditional Drug
Facts label (eg, behavioural programmes, educational materials)
to promote safe and efective use in an OTC environment.
When considering the medical needs of todays ageing population
and potential options available to consumers to manage their own
health, future switch candidates might include antihypertensive
Figure 1: PDUFA fees over time.
Full application with clinical data
Full application without clinical data, or supplement with clinical data
Establishments
Products
$2,500,000
$2,000,000
$1,500,000
$1,000,000
$500,000
$0
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7
www.topra.org Regulatory Rapporteur Vol 10, No 3, March 2013
Focus OTC medicines
agents, cholesterol-lowering drugs, oral antidiabetic agents, and
treatments for osteoporosis.
It is imperative that we challenge our industry to explore ways to
enable these innovative future switches by broadening the assistance
and information a consumer receives to use products safely and
efectively without a doctors supervision. Companies can work with
the FDA to defne ways to address unique challenges that may be
associated with these potential switches. Consideration of appropriate
special conditions of safe use on a case-by-case basis can enable
progress within the current US two-tier regulatory paradigm.
Also, as we consider the possibility of expanding OTC treatment
Table 3: Comparison of OTC monograph and NDA processes.
OTC monograph New drug application (NDA)
No pre-market approval required Pre-market approval of NDA
No fling fees May require user fee if new clinical studies required
Public process Confdential fling
No marketing exclusivity Potential marketing exclusivity if new clinical studies required
Covers active ingredients/therapeutic classes Drug product-specifc
No mandated FDA review timelines Mandated FDA review timelines
FDA approval of brand name not required FDA approval of brand name required
No FDA approval required for post-marketing changes that conform
to monograph
l FDA pre-approval required for moderate or major changes
l FDA notifcation required for minor changes
Clinical studies required for claims support only May require to support:
l Safety and efcacy
l Label comprehension
Label must conform to monograph and Drug Facts label
requirements.
l Label must conform to Drug Facts label requirements.
l Content of labelling to be developed and approved by the FDA
based on the results of:
l Clinical studies
l Label comprehension studies
l Self-selection studies
l Actual use studies.
Table 2: Examples of products switched from Rx to OTC status in the US.
Approved Brand name Active ingredient Indication
October 2002 Commit nicotine polacrilex Smoking cessation
November 2002 Claritin loratidine Allergy (antihistamine)
June 2003 Prilosec OTC omeprazole magnesium Acid reducer to treat frequent heartburn
August 2006 Plan B levonorgestrel Contraceptive
October 2006 MiraLAX polyethylene glycol3350 Laxative
February 2007 Alli orlistat Weight-loss aid
January 2013 Oxytrol oxybutynin Overactive bladder in women
options, it becomes increasingly important to establish rigorous tools
for assessing the beneftrisk profle of these products. A systematic,
quantitative assessment tool can help identify and evaluate incremental
risks and benefts associated with OTC use and provide transparency and
consistency to the regulatory decision-making process.
21
A comparison
of the OTC monograph and NDA process appear in Table3.
Specifc OTC requirements
Although many of the same regulations apply to OTC and Rx drugs,
diferent rules apply to OTC packaging, labelling, and advertising and
promotion.
8
Regulatory Rapporteur Vol 10, No 3, March 2013 www.topra.org
The level of substantiation required is directly linked to the nature
of claims and must form a reasonable basis for the claims with
objective evidence. For example, health or related claims would
require credible scientifc evidence gathered using methods that
experts in the feld accept as accurate.
Conclusion
OTCs deliver tremendous value to individual consumers and the US
healthcare system as a whole. The general sales status of OTCs in the
US marketplace provides the American consumer with convenient
access to important self-care options. Non-prescription medicines are
introduced to the US marketplace via two distinct regulatory pathways:
the OTC monograph system for well-established ingredients and the
NDA process for drugs that are new in terms of active ingredient,
indications, doses or formulation. The OTC monograph process has
the advantage of speed to market for qualifying products, since FDA
pre-approval is not required. The NDA route is more time-consuming
and data-intensive potentially requiring studies to assess labelling,
consumer behaviour and actual use in an OTC setting however,
exclusivity may be achieved if clinical investigation is required to
achieve product approval. By understanding the regulatory framework
and requirements for each class of products, regulatory professionals
can better lead innovation in this exciting area of healthcare.
References
1 FDA. Regulation of Nonprescription Products. Available at http://www.fda.
gov/AboutFDA/CentersOfces/OfceofMedicalProductsandTobacco/CDER/
ucm093452.htm; last updated: 01/26/2012. (Accessed 25 January 2013).
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States: 2011, Issued September 2012. Available at http://www.census.gov/
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3 White paper on the benefts of OTC medicines in the United States: A
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Committee, Pharmacy Today, October 2010. Available at http://www.chpa-
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the-CounterDrugs/default.htm, Date last updated 10/18/2012 (Accessed
25January 2013).
9 J Derbis,B Evelyn, Judy McMeekin. FDA aims to remove unapproved
drugs from market-risk-based enforcement program focuses
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August 2008. Available at http://www.fda.gov/downloads/Drugs/
Packaging requirements: Regulation is often reactive and driven by
tragedy. A series of accidents involving the death or injury of children
due to the ingestion of hazardous household substances led to the
enactment of the Poison Prevention Packaging Act (PPPA) of 1970, under
the authority of the Consumer Product Safety Commission (CPSC). The
PPPA requires child-resistant packaging for certain OTCs (eg, aspirin,
diphenhydramine, acetaminophen) and oral non-prescription drugs
that were previously available by prescription (switched drugs).
The regulations require that packaging be signifcantly difcult for
a child under fve years of age to open or obtain a toxic amount of the
substance, while also not impeding a normal adult from proper use.
Similarly, tampering incidents involving Tylenol capsules laced
with cyanide in the early 1980s led to the implementation of strict
tamper-resistant packaging requirements in 1982. All OTCs (except
dermatological, dentifrice, insulin or lozenge products) must be packaged
in tamper-resistant packaging and be labelled to prominently disclose the
tamper-evident features. Additionally, two-piece hard gelatin capsules
must be sealed using an acceptable tamper-evident technology.
Labelling requirements: For consumers to safely and efectively use
OTC medicines without the assistance of a learned intermediary, the
labelling of the product needs to be clear, legible and readily understood
by a lay person. In 1999, the FDA established standardised format and
content requirements for the labelling of OTC drug products NDA and
monograph drugs alike. Known as Drug Facts, these requirements were
analogous to the Nutrition Facts labelling standards implemented in
1992.
22
The Drug Facts label required the following elements:
l Use of standardised headings to organise important information such
as ingredients, product uses, specifc warnings and dosing instructions
l Prescribed order of information to help consumers locate
information across OTC products and brands
l Use of plain-speaking terms to promote consumer understanding,
particularly in those with low literacy
l Minimum font size and specifc layout details (bullets, line spacing,
and clearly marked sections) to improve readability.
OTC regulations may also require certain ingredient-specifc or
class-specifc warnings; for example, the warning statement for drug
products containing or manufactured with chlorofuorocarbons
(CFCs) or other ozone-depleting substances. These warnings may
appear in the Other Information section of the label.
23
Advertising and promotion: Regulation of the advertising and promotion
of OTCs in the US falls under the auspices of the Federal Trade Commission
(FTC). This is diferent from the advertising and promotion of prescription
products, which are directly regulated by the FDA. The FDA and FTC have
distinct roles in consumer protection; nonetheless, both often engage in
cooperative eforts when it is in the best interest of public health.
24
The standards that FTC uses when assessing OTC advertising are:
25
l Advertising must be truthful and non-deceptive; not likely to
mislead consumers acting reasonably under the circumstances
l Advertisers must have evidence to back up their claims
l Advertisements cannot be unfair.
The FTC assesses advertising from the point of view of a reasonable
consumer and evaluates the totality of the advertisement, ie,
words, phrases and pictures. In this context, the FTC examines both
express and implied claims to determine the message conveyed to
consumers and whether it is appropriate and substantiated. Although
fair balance is not strictly required as with prescription products, the
FTC also looks at what the advertisement does not say, to ensure it is
not misleading or deceptive by omission of information.
Focus OTC medicines
9
www.topra.org Regulatory Rapporteur Vol 10, No 3, March 2013
Focus OTC medicines
GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/
SelectedEnforcementActionsonUnapprovedDrugs/ucm119899.pdf.
(Accessed 25January 2013).
10 FDA. Guidance for FDA Staf and Industry Marketed Unapproved Drugs
Compliance Policy Guide (Sec. 440.100 Marketed New Drugs Without
Approved NDAs or ANDAs), 19September 2011. Available at http://www.
fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/
Guidances/UCM070290.pdf
11 FDA. Draft Guidance for Industry: Time and Extent Applications,
February 2004. Available at www.fda.gov/downloads/http://www.fda.
gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/
Guidances/UCM078902.pdf (Accessed 25 January 2013)
12 FDA. New Drug Application. Available at http://www.fda.gov/Drugs/
DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/
ApprovalApplications/NewDrugApplicationNDA/default.htm, Date Last
Updated: 05/18/2012 (Accessed 25January 2013).
13 E P Brass, M Weintraub. Label development and the label comprehension
study for over-the-counter drugs, Clin Pharmacol Ther, 2003;74:406-12.
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counter availability, New England Journal of Medicine, 2001;345:810-6.
15 E P Brass, L E Shay, A Leonard-Segal. Analysis of multiple end points in
consumer research in support of switching drugs from prescription to over-
the-counter status: The concept of end-point hierarchies, Clin Pharmacol
Ther, 2009;85:369-74.
16 FDA. Guidance for Industry: Label Comprehension Studies for
Nonprescription Drug Products, August 2010. Available at www.fda.
gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/
Guidances/UCM143834.pdf. (Accessed 25January 2013).
17 FDA. PDUFA Legislation and Background. Available at http://www.fda.
gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm144411.htm.
(Accessed 25January 2013).
18 FDA. PDUFA User Fee Rates Archive. Available at http://www.fda.gov/
ForIndustry/UserFees/PrescriptionDrugUserFee/ucm152775.htm.
(Accessed 25January 2013).
19 FDA. Now Available Without a Prescription. Available at http://www.fda.
gov/Drugs/ResourcesForYou/Consumers/ucm143547.htm. (Accessed 26
January 2013).
20 Consumer Healthcare Products Association. Rx to OTC Switch List,
(updated February 2011. Available at http://www.chpa-info.org/media/
resources/r_4620.pdf . (Accessed 26January 2013).
21 E P Brass, R Lofstedt, O Renn. Improving the Decision-Making Process for
Nonprescription Drugs: A Framework for BeneftRisk Assessment, Clin
Pharmacol Ther, advance online publication 2November 2011.
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ResourcesForYou/Consumers/ucm143551.htm, Date last updated
05/28/2009 (Accessed 25January 2013).
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Entity Compliance Guide), May 2009. Available at http://www.fda.
gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/
Guidances/UCM150994.pdf (Accessed 25 January 2013)
24 Consumer Healthcare Products Association. OTC Drug Advertising,
available at http://www.chpa-info.org/scienceregulatory/Drug_
Advertising.aspx. (Accessed 25January 2013).
25 Federal Trade Commission. Advertising FAQs: A Guide for Small Business.
Available at http://business.ftc.gov/documents/bus35-advertising-faqs-
guide-small-business. (Accessed 25January 2013).
CRED LCM: Optimising Regulatory Strategy for Global Development & Lifecycle Maintenance
Aim
This practical CRED workshop will look into Global clinical and
CMC development as well as lifecycle management focusing
on a number of key areas including China, Japan and Russia.
Who should attend?
The less experienced regulatory professional who
requires comprehensive information on a subject
The experienced professional who is a newcomer to
working in a global arena
Anyone who wishes to update their knowledge in
global regulatory strategy
Programme includes
Day 1: Global Development
Introduction to global clinical development
Introduction to global CMC development
Regulatory Agencys Perspective on Regulatory
requirements for Marketing Authorisations Japan
Two-day
course
Date:
1213 June 2013
Venue:
London, UK
ENABLING AND PROMOTING EXCELLENCE IN THE HEALTHCARE REGULATORY PROFESSION
WORKSHOPS
Regulatory requirements for Marketing
Authorisations Russia
Regulatory requirements for Marketing
Authorisations Key International Markets
Regulatory Agencys Perspective on Regulatory
requirements for Marketing Authorisations USA
Day2: Maintenance
Introduction to global lifecycle management CMC
Introduction to global lifecycle management safety
& labelling
Regulatory agencys perspective on lifecycle
management Japan
Lifecycle management China
Lifecycle management International Markets
Key industry and agency speakers have been invited
More information: www.topra.org/cred-gds
email: meetings@topra.org tel: +44 (0) 20 7510 2560 fax: +44 (0) 20 7537 2003 web: www.topra.org/cred-gds
CRED GDS
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