Regulatory submissions for new products
Regulated Product Submission (RPS)
is a Health Level Seven (HL7) standard designed to facilitate the processing
and review of regulated product information. RPS is being developed in response
to performance goals that the U.S. Food and Drug Administration (FDA) is to
achieve by 2012, as outlined in the Prescription Drug User Fee Act (PDUFA) In
addition to the U.S., regulatory agencies from Europe, Canada, and Japan are at
varying levels of interest and participation. Currently, the second release of
RPS is in development.
Authorities such as the FDA receive
numerous submissions that address a variety of regulatory issues. The
information contained in these submissions is divided into large numbers of
files, both paper and electronic. Often, files in one submission are related to
files in earlier submissions. Because the information is divided into numerous
files sent over time, it can be difficult to efficiently process and review the
information.
While the general data layouts of
all regulated products are the same, different product types have different
lists of topics that must be addressed within the submission. Therefore, the
goal of RPS is to create an HL7 XML message standard for submitting information
to regulatory authorities. Each message includes the contents of a regulatory
submission plus information such as metadata, which is necessary to process
submissions.The Refined Message Information Model (R-MIM) shows the structure
of a message as a color-coded diagram. R-MIM diagrams are designed to capture
all required information for the efficient processing and review of regulatory
submissions and to explain what each message consists of. This makes RPS
general enough to handle all regulated products while containing enough
information to allow regulators to support structured review.
The project to develop a regulated
product submission standard was initiated on June 22, 2005.Release 1 was
spearheaded by Jason Rock of GlobalSubmit, with the aim of creating one
standardized submission format to support all of the FDA's electronic product
submissions. The Health Level 7 message was created by leveraging existing
human pharmaceutical experience, such as The International Conference on
Harmonisation of Technical Requirements for Registration of Pharmaceuticals for
Human Use (ICH).RPS Release 1 provides the capability to cross-reference
previously submitted material owned by the sponsor as well as append, replace
and delete parts of the document lifecycle.Release 2, led by Peggy Leizear of
the Office of Planning at the FDA, grants the ability to exchange contact information,
classify submission content and handle multi-region submissions.The second
release of RPS also handles two-way communication—The regulatory authority
(e.g. FDA) will use RPS to send correspondence (e.g. request for additional
information, meeting minutes, application approval) to the submitter.
RPS structure
As the industry moves away from
paper submissions, global companies producing regulated products will benefit
from having a published electronic submission standard. The label of “regulated
product” applies not only to pharmaceuticals, but also extends to include food
additives, medical devices and radiologics, human therapeutics, biologics and
veterinary products.
The submitted information is
structured as a collection of documents, organized by report sections. Multiple
documents can be assigned to a single report section. The actual table of
required and optional report sections varies from product to product and is
defined by regulatory authorities. Since the same information can be submitted
to support multiple applications, it is imperative that RPS allow for the reuse
of data between applications.
RPS and eCTD
RPS is in many ways comparable to
the electronic Common Technical Document.Ideally, the FDA would like to
implement RPS as the next iteration of eCTD. The idea behind RPS and ICH’s eCTD
is the same—the use of a standardized format for regulatory submissions,
including PDF documents and SAS datasets. Although document contents are the
same for eCTD and RPS, the internal XML structures are very different.RPS will
offer two obvious advantages over eCTD. First, RPS will establish two-way
communication between the submitter and all FDA-regulated product centers
within the agency.Second, RPS will manage the life cycle of submissions by
allowing cross-referencing of previously submitted information.This means that
for electronic Investigational New Drug (IND) applications, New Drug
Applications (NDA), and Biologic License Applications (BLAs), information need
only be submitted once and previously submitted electronic documents can be
applied to marketing applications.With RPS, archived electronic IND, NDA, and
BLA submissions will be retrievable through standardized automated links.eCTD
lacks this cross-referencing capability.
Regulatory Submissions in Electronic Format for Biologic
Products
There are extensive requirements in
the Code of Federal Regulations (CFR) regarding the information that needs to
be submitted in order to seek approval to begin clinical testing of a biologic
product and to market a biologic product. FDA has started the transition to a
more automated electronic review process for these submissions.
Key Resources
Electronic Submissions Gateway
Information on how to submit documents to FDA electronically.
-
Information on Electronic Submission
of Regulatory Documents to CBER
Food and Drug Administration
Electronic Submissions Gateway (Federal Register Notice) - 8/9/2006 ---August
9, 2006
FDA Announces the Use of New
Electronic Drug Labels to Help Better Inform the Public and Improve Patient
Safety----November 2, 2005
Individual Case Safety Reports
(ICSR) - Specifications
SOPP 8110: Submission of Paper
Regulatory Applications to CBER Effective Date: June 3, 2010
SOPP 8116: Using Electronic
Signatures for Investigational and Marketing Regulatory Document
Concurrence/Signoff Effective Date: April 23, 2012
SOPP 8117: Issuing Submission
Numbers in Advance of the Receipt of the Electronic Submission Effective Date:
September 24, 2007
Submission of Data in CDISC Format
to CBER Effective Date: May 15, 2010 Updated: January 3, 2010
Guidances & Rules
Postmarketing Safety Reports for
Human Drug and Biological Products; Electronic Submission Requirements,
Proposed Rule (Federal Register 8/21/2009
Medical Device Reporting: Electronic
Submission Requirements, Proposed Rule (Federal Register) 8/21/2009
Providing Regulatory Submissions in
Electronic Format – Drug Establishment Registration and Drug Listing ---Drug Establishment Registration and Drug
Listing, May 2009
Indexing Structured Product Labeling
---June 12, 2008
Providing Regulatory Submissions in
Electronic Format – Postmarketing Individual Case Safety Reports ---June 11,
2008
Providing Regulatory Submissions in
Electronic Format -Human Pharmaceutical Product Applications and Related
Submissions Using the eCTD Specifications ---June 11, 2008
Providing Regulatory Submissions to
the Center for Biologics Evaluation and Research (CBER) in Electronic Format -
Biologics Marketing Applications----November 1999
(Ref: www.fda.gov/BiologicsBloodVaccines/.../ucm163685.htm)
What data is needed ?
Current Federal law requires that a
drug be the subject of an approved marketing application before it is
transported or distributed across state lines. Because a sponsor will probably
want to ship the investigational drug to clinical investigators in many states,
it must seek an exemption from that legal requirement. The IND is the means
through which the sponsor technically obtains this exemption from the FDA.
During a new drug's early
preclinical development, the sponsor's primary goal is to determine if the
product is reasonably safe for initial use in humans, and if the compound
exhibits pharmacological activity that justifies commercial development. When a
product is identified as a viable candidate for further development, the
sponsor then focuses on collecting the data and information necessary to
establish that the product will not expose humans to unreasonable risks when
used in limited, early-stage clinical studies.
FDA's role in the development of a
new drug begins when the drug's sponsor (usually the manufacturer or potential
marketer) having screened the new molecule for pharmacological activity and
acute toxicity potential in animals, wants to test its diagnostic or
therapeutic potential in humans. At that
point, the molecule changes in legal status under the Federal Food, Drug, and
Cosmetic Act and becomes a new drug subject to specific requirements of the
drug regulatory system.
There are three IND types:
An Investigator IND is submitted by
a physician who both initiates and conducts an investigation, and under whose
immediate direction the investigational drug is administered or dispensed. A physician might submit a research IND to
propose studying an unapproved drug, or an approved product for a new indication
or in a new patient population.
Emergency Use IND allows the FDA to authorize use of an
experimental drug in an emergency situation that does not allow time for
submission of an IND in accordance with
21CFR , Sec. 312.23 or Sec. 312.34.
It is also used for patients who do not meet the criteria of an existing
study protocol, or if an approved study protocol does not exist.
Treatment IND is submitted for
experimental drugs showing promise in clinical testing for serious or
immediately life-threatening conditions while the final clinical work is
conducted and the FDA review takes place.
There are two IND categories:
Commercial
Research (non-commercial)
The IND application must contain
information in three broad areas:
Animal Pharmacology and Toxicology
Studies - Preclinical data to permit an assessment as to whether the product is
reasonably safe for initial testing in humans.
Also included are any previous experience with the drug in humans (often
foreign use).
Manufacturing Information - Information pertaining to the composition,
manufacturer, stability, and controls used for manufacturing the drug substance
and the drug product. This information
is assessed to ensure that the company can adequately produce and supply
consistent batches of the drug.
Clinical Protocols and Investigator
Information - Detailed protocols for proposed clinical studies to assess
whether the initial-phase trials will expose subjects to unnecessary
risks. Also, information on the qualifications
of clinical investigators--professionals (generally physicians) who oversee the
administration of the experimental compound--to assess whether they are
qualified to fulfill their clinical trial duties. Finally, commitments to obtain informed
consent from the research subjects, to obtain review of the study by an
institutional review board (IRB), and to adhere to the investigational new drug
regulations.
Once the IND is submitted, the
sponsor must wait 30 calendar days before initiating any clinical trials. During this time, FDA has an opportunity to review the IND for
safety to assure that research subjects will not be subjected to unreasonable
risk.
(ref: http://www.fda.gov/drugs/)
Requirements for gaining approval US perspective
The value of the global
pharmaceutical market is expected to
grow 5-7 percent in 2011, to USD 880
billion according to IMS Health. The
pharmaceutical industry is one of the
highly regulated industries, to protect the
health and well being of the masses. The
structures of drug regulation that exist today i.e. drug laws, drug regulatory agencies, drug
evaluation boards, quality control
laboratories, drug information
centers, etc., have evolved over time in response both to the increasingly
sophisticated pharmaceutical sector, and to the apparent needs of society. In
some countries, the passing of comprehensive drug laws was a result of
crisis-led change, when public demand led to the adoption of more restrictive
legislations to provide stronger safeguards for the public. While drug laws
provide the basis for drug regulation, regulatory tools such as standards and guidelines equip drug regulatory authorities with the practical means of implementing those laws. Though the world pharmaceutical regulations are in continuous process of harmonization, they can be divided into four major categories based on the region, development strategy,
regulations and marketing interest.
1. North
America (US, Canada)
2. Europe
(Europe Union, Eastern
Europe)
3. Rest
of the World (Asia Pacific minus
Japan, ANZ, GCC, LATAM, CEE,
CIS)
3. Japan
(LATAM: Latin America; CEE – Central
East Europe; CIS – Commonwealth Independent
States; ANZ – Australia, New Zealand;
ROW – Rest of World)
Based on the economy and regulatory control of the countries, these are grouped into Regulated markets (US, EU, Japan, ANZ) or Emerging Markets (ROW excluding ANZ). They not only differ by their region, but also in various other aspects like: how they regulate the pharmaceuticals, the different
guidelines for registering the drugs, requirements
to maintain the registrations, registration
fee, patent regulations and so
on.
North America
Both USA and Canada are the major markets
in the pharma industry. The US enjoys the largest player tag in terms of value
in the pharma sector. It is valued approximately at USD 300 bn in 2009. The US
has evolved from no regulation in the 18th century to one of the highly
admired,
favorite regulatory authority in the
world. The Food and Drug Administration (FDA) within the U.S. Department of
Health and Human Services, regulates the drug approval system in United States
with the help of six product centers including Center for Drug Evaluation and
Research (CDER) and Center for Biologicals Evaluation and Research (CBER).
The drug registration procedure in
US is majorly categorized into three parts, New Drug Applications (NDA),
Abbreviated New Drug Applications (ANDA) and the
mix of both which is widely called as 505 (b)(2) Applications. Fig. 1
illustrates the different kinds of routes available to get the registration of
pharmaceuticals in US under the Section 505 of the ‘Federal Food Drug
and Cosmetic Act’. Till 1980s,
mostly innovators dominated the US pharma market. The introduction of “Drug
Price Competition and Patent Term Restoration Act of 1984” i.e. Hatch-
Waxman Act can be termed as birth of
generic industry in US which helped generic
companies to flourish in US.
New Drug Application (NDA):
This route is mainly used to get the
approval for New Chemical Entities (NCE)
which contains full reports of
investigations of safety and
effectiveness (Pre-clinical, Phase I to
Phase IV study reports). NDA is preceded
by the Investigational New Drug Application
(IND).
505(b)(2) Application:
This application is same as full NDA,
except that this NDA is based on “investigations … relied on by the
applicant for approval of the
application …and for which the applicant
has not obtained a right of reference or
use. The applicant majorly relies on
published literature, FDA’s
Federal Register. This route is
often used for changes to an approved
drug (Change in
dosage form, strength, indication
etc.)
505(j) or ANDA or Generic Drug Application:
This section is used for obtaining marketing authorization of exact or close copies of already approved drugs. The application is submitted under any of the below subsections of 505(j) of Federal Act
In Canada, the manufacturer may seek
authorization to sell the product in Canada by filing a New Drug Submission
with Health Products and Food Branch (HPFB). A New Drug Submission (NDS),
typically contains scientific information about the product’s safety, efficacy
and quality. It includes the results of both the pre-clinical and clinical studies.
An Abbreviated NDS (ANDS) is used for a generic product. The generic product
must be shown to be as safe and efficacious as the reference product usually established
with bioequivalence studies. A Supplemental NDS (SNDS) must be filed by the
manufacturer if certain changes are made to already-authorized products.
Such changes might include the
dosage form or strength of the drug product, the formulation, method of
manufacture, labeling or recommended route of administration. An SNDS must also
be submitted to HPFB if the manufacturer wants to expand the indications
(claims or conditions of use) for the drug product.
(Ref: http://www.ipapharma.org/pt/sep2011/15-20.pdf)
Regulating control over marketing and sales of medical products
General Controls for Medical Devices
Introduction
General Controls are the basic
provisions (authorities) of the May 28, 1976 Medical Device Amendments
(hereafter referred to as the Amendments) to the Food, Drug and Cosmetic Act,
that provide the FDA with the means of regulating devices to ensure their
safety and effectiveness. The General Controls in the Amendments apply to all
medical devices. They include provisions that relate to adulteration;
misbranding; device registration and listing; premarket notification; banned
devices; notification, including repair, replacement, or refund; records and
reports; restricted devices; and good manufacturing practices.
Application
of The Provisions of General Controls
Devices are classified according to
the degree of difficulty in assuring their safety and effectiveness. Class I,
which is synonymous with General Controls, is the least stringent of the three
device classes provided in the Amendments. Before placing a device in Class I,
the FDA must first determine that there is sufficient information available to
support such a classification decision. Second, the FDA must decide that the
General Controls are sufficient to provide reasonable assurance of the device's
safety and effectiveness. Class I devices are not subject to the restrictions
of Class II - Special Controls or Class III - Premarket Approval. In addition,
Class I devices are not intended for use in supporting or sustaining life or to
be of substantial importance in preventing impairment to human health, and they
may not present a potential unreasonable risk of illness or injury
Unless otherwise exempted, the
General Controls provisions of the Amendments are applicable to all devices
regardless of their classification status.
KEY POINTS
General Controls are the basic
authorities of the Medical Device Amendments that provide the FDA with the
means of regulating devices to ensure their safety and effectiveness.
General Controls apply to all three
classes of medical devices; however, they are the only level of controls that
apply to Class I devices.
Class I devices are not intended to
be:
For use in supporting or sustaining
life;
Of importance in preventing
impairment to human life; and may not
Present a potential unreasonable
risk of illness or injury
General Controls include the
provisions of the Act pertaining to:
Adulteration;
Misbranding;
Device registration and listing;
Premarket notification;
Banned devices;
Notification and repair,
replacement, and refund;
Records and reports;
Restricted devices; and
Good Manufacturing Practices.
Adulteration
Medical devices are subject to the
adulteration provisions of the FD&C Act under Section 501. The first two
provisions of Section 501 define adulteration for most cases. A device is held
to be adulterated if it includes any filthy, putrid, or decomposed substance,
or if it is prepared, packed, or held under unsanitary conditions. The FD&C
Act further states that a device is held to be adulterated if:
Its container is composed, in whole
or part, of any poisonous or deleterious substance;
It contains, for the purposes of
coloring only, an unsafe color additive; and
Its strength differs from, or its
purity or quality falls below, that which it claims to represent.
When the Medical Device Amendments
were added to the FD&C Act, certain conforming laws, applying specifically
to medical devices, were added to Section 501. These provisions relate directly
to other portions of the Amendments, granting the FDA authority to control
performance standards; compliance with premarket approval applications and
product development protocol requirements; banning; good manufacturing
practices; and investigational device exemptions. These sections state that a
device will also be considered adulterated if:
It is subject to a performance
standard and does not comply with all the requirements of the standard;
It is a Class III device and fails
to conform to the requirements for an approved premarket approval application
or a notice of completion of a product development protocol;
It is a banned device;
It is in violation of good
manufacturing practice requirements; or
It fails to comply with an
Investigational Device Exemption (IDE).
Misbranding
The misbranding provisions of the
FD&C Act in Section 502 cover various aspects of drug and device labeling
requirements. Many of the provisions apply to drugs and devices both; however,
there are also specific misbranding provisions that apply to only drugs or only
devices. The misbranding provisions that apply to both drugs and devices are
listed in the following:
Drugs and Device Misbranding Provisions
A drug or device is deemed to be
misbranded if:
Its labeling is false and
misleading.
Its packaging does not bear a label
containing:
the name of the place of business of
the manufacturer, packer, or distributor, and
an accurate statement of the
quantity of contents in terms of weight, measure, or numerical count.
Reasonable variations and exemptions
for small packages may be permitted.
Any word, statement, or other
required information is not prominently placed on the labeling or not clearly
stated so as to be read and understood by the ordinary individual under
customary conditions of purchase and use.
It is for use by man and contains
any quantity of a narcotic or habit forming substance, unless its label bears
the name and quantity or proportion of the substance or derivative and the
statement "Warning - may be habit forming."
Its label does not bear adequate
directions for use. The label must include warnings against use in certain
pathological conditions or by children where its use may be dangerous to
health, or against unsafe dosage or methods or duration of administration or
application. Adequate directions and warnings must be present when it is
necessary to protect the health of the user. Exemptions to this provision may
be obtained. The phrase "adequate directions for use" pertains to
over-the-counter drugs and device.
It is dangerous to health when used
in the dosage or manner, or with the frequency or duration prescribed,
recommended, or suggested in the labeling.
It does not comply with the color
additive provisions listed under Section 706 of the FD&C Act.
Device Misbranding Provisions Added by the Amendments
The Amendments added new authority
relating to the misbranding of medical devices. These new provisions state that
a device is misbranded if:
The device's established name (if it
has one) or its name in an official compendium, or any common or usual name, is
not prominently printed in type at least half as large as that used for any
proprietary name or designation. Exemptions from this provision may be granted.
A restricted device offered for sale
in any State uses false or misleading advertising, or is sold, distributed, or
used in violation of restricted device regulations under Section 820(e) of the
FD&C Act.
A restricted device manufacturer,
packer, or distributor fails to include in all advertisements or other
descriptive materials:
a true statement of the device's
established name, prominently printed, and
a brief statement of the intended
uses of the devices and relevant warnings, precautions, side effects, and
contradictions.
The device commercially distributed
without FDA concurrence on a Section 510(k) submission.
The device is subject to a
performance standard and it does not bear the labeling prescribed in that
standard.
There is a failure or refusal to
comply with any requirement prescribed under section 518 (Notification and
Other Remedies); to furnish any material or information required by or under
Section 518; or to furnish any material or information requested by or under
Section 519 (Records and Reports on Devices).
False or Misleading
Labeling
The FD&C Act states that a drug
or device is misbranded "if its labeling is false or misleading in any
particular." "Labeling" includes the label and any other
written, printed, or graphic material that accompanies a device and any of its
wrappers or containers. Operating and servicing instructions are also regarded
as part of the labeling. The labeling must bear adequate directions for use and
any warnings needed to ensure the safe and effectiveness use of the device
Medical Device Labeling Information
Establishment
Registration Requirements
The Amendments require in Section
510 that manufacturers and other specified processors of devices register their
establishments with the FDA and provide to the FDA a list of all devices
manufactured in any establishment which they operate. Repackers, relabelers,
and importers are also required to register with the FDA.
Device Listing
Requirements
Section 510 also states that medical
device manufacturers must submit to the FDA a list of all devices they produce
or process. This listing is maintained by the FDA.
Premarket Notification Requirements
Section 510(k) of the FD&C Act
requires a manufacturer who intends to market a medical device to submit a
premarket notification [510(k)] to the Agency at least 90 days before
introducing the device onto the market. Premarket approval status is automatic
for all devices found to be not substantially equivalent to preamendments
devices. Based on the information provided in the notification, the Agency must
determine whether the new device is substantially equivalent to a device
already marketed or if it is not an equivalent device. A non equivalent device
must have an approved premarket approval (PMA) application or be reclassified
into Class I or Class II before being marketed. The final determination of
whether a device is substantially equivalent or non equivalent resides with the
FDA.
Premarket Notification [510(k)] -
How to market a 510(k) Medical Device
Banned Devices
Section 516 of the FD&C Act
authorizes the Agency to ban devices that present substantial deception or
unreasonable and substantial risk of illness or injury. The procedures for
banning a device are described below. If the Agency determines, on the basis of
all available data and information and after consulting with the appropriate
classification panel, that a device intended for human use presents such
deception or risk of illness or injury, which cannot be corrected by a change
in the labeling, then the Agency may publish a proposed regulation to ban the
device in the Federal Register. If the deception or risk can be corrected by a
change in the labeling, the Agency must notify the responsible person of the
deception or risk, the change in labeling needed to correct it, and the time
period within which the change should be made. If the labeling is not changed
in the specified time and manner, then the Agency may publish the proposed
regulation. After affording all interested persons an opportunity for an
informal hearing on the proposal, the Agency will affirm, modify, or revoke the
proposed regulation. If the proposal is affirmed or modified, the Agency will
publish a final regulation banning the device. In this case, the device can no
longer be legally marketed on and after the date of publication of the final
regulation, except under an approved investigational device exemption. If the proposed
regulation is revoked, the Agency will publish a notice to this effect in the
Federal Register.
Notification
and Other Remedies
Section 518 of the Act deals with
notification and other remedies for protecting the public from faulty or
fraudulent devices.
Purpose Of Section 518
The main purpose of Section 518 is
protection of the public health. Section 518 offers FDA a way of assuring that
hazardous products in the hands of consumers and other users are repaired,
replaced, or refunded. In addition to the public health purpose of Section 518,
this section also gives consumers a procedure for economic redress when they
have been sold defective medical devices that present unreasonable risks.
Notification [518(a)]
Under this Section of the FD&C
Act, FDA may require manufacturers or other appropriate individuals to notify
all health professionals who prescribe or use the device and any other person
(including manufacturers, importers, distributors, retailers, and device users)
of the health risks resulting from the use of the violative device, so that
these risks may be reduced or eliminated.
Threshold Requirements
FDA can order notification if:
A device presents an unreasonable
risk of substantial harm to public health;
Notification is necessary to eliminate
the risk; and
No more practicable means are
available under the FD&C Act to eliminate the risk.
Procedures
The procedures for a notification
order are simple. They involve only prior consultation with the persons who are
to provide the notification.
Repair, Replacement, or Refund Provisions [518(b)]
Section 518(b) authorizes the FDA,
after offering an opportunity for an informal hearing, to order manufacturers,
importers, or distributors to repair, replace, or refund the purchase price of
devices that present unreasonable health risks.
Basic Criteria
The FDA can order repair,
replacement or refund (3-R) if, after opportunity for an informal hearing , it
determines that:
The device represents an
unreasonable risk of substantial harm to the public health;
The device was not designed and
manufactured in accordance with the then prevailing state of the art;
The risk is not due to negligent
installation, maintenance, repair, or use of the device by persons other than a
manufacturer, importer, distributor, or retailer; and
Notification alone is insufficient,
and repair, replacement, or refund is necessary.
Procedures
The procedures for repair,
replacement, or refund are complex and could result in multiple orders,
regulatory hearings, and much delay if FDA and the manufacturer, or other
responsible person, are unable to agree on a plan for addressing a risk. The
Agency must consider available alternatives. Both notification orders and
repair, replacement, or refund orders are discretionary. Before ordering
notification, FDA must determine that no more practical means are available
under the FD&C Act to eliminate the risk. Although there is no requirement
that such a determination be made before FDA orders repair, replacement, or
refund, FDA must determine that notification alone is insufficient before
ordering repair, replacement or refund.
FDA's alternatives to Section 518
are the following approaches:
Legal actions (seizures, injunctions,
prosecutions);
Regulations (e.g., banning or
imposing restrictions on sale, distribution or use); and
Recalls (under FDA's recall
regulations).
Records and Reports On Devices
Section 519 of the Act authorizes
the FDA to promulgate regulations requiring manufacturers, importers, and
distributors of devices to maintain records and reports to assure that devices
are not adulterated or misbranded.
Records and reports regulations
promulgated under Section 519:
May not impose requirements that are
unduly burdensome to the manufacturer, importer, or distributor;
Must state the reason and purpose
for procedures requesting reports or information;
Must state the reason and purpose
for submission of reports or information;
May not require that the identity of
any patient be disclosed; and
May not require a manufacturer,
importer, or distributor to maintain or submit reports or information not in
his/her possession.
Records and reports requirements do
no apply to:
Practitioners who prescribe or
administer devices solely in the course of their professional practice;
Manufacturers or importers of
devices used solely in research or teaching; and
Other persons exempt by regulation.
Restricted Devices
Under the provision of Section
520(e) of the Amendments, the FDA is authorized to restrict the sale,
distribution, or use of a device if there cannot otherwise be reasonable
assurance of its safety and effectiveness. A restricted device can only be sold
on oral or written authorization by a licensed practitioner or under conditions
specified by regulation. Devices such as cardiac pacemakers and heart valves,
for example, require a practitioner's authorization. Hearing aids are
restricted by a regulation which limits their sale to persons who have obtained
a medical evaluation of their hearing loss by a physician within six months
prior to the sale of the hearing aid. The labeling of hearing aids must provide
information on their use and maintenance.
Quality
System Regulation, Good Manufacturing Practices
Section 520(f) of the Amendments
authorizes the FDA to promulgate regulations requiring the methods used in, and
the facilities and controls used for, the manufacturing, packing, storage, and
installation of a device to conform to current good manufacturing practices
(GMPs).
(Ref:http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/GeneralandSpecialControls/ucm055910.htm)
Regulations Codes of practice Promotional materials
The research-based pharmaceutical industry is the
primary source of information about its own products and recognizes its
responsibility for ensuring product information is accurate and does not
mislead. Advertising and promotion are essential for informing healthcare
professionals about new medicines and new uses for existing medicines.
Self-regulation, via the IFPMA Code of Practice, supplemented by member
association and company codes, sets standards for the ethical promotion of
medicines.
Self-Regulation
of Pharmaceutical Promotion
The international research-based pharmaceutical
industry is committed to the improvement of the health of mankind through the
research, development, production, marketing and safety surveillance of new
medicines of reliable quality, in accordance with internationally defined
standards of good practice.
As part of its commitment to health, the industry
has an obligation and responsibility to provide accurate information about its
products to healthcare providers in order to appropriately use prescription
medicines.
Promotional activities (i.e. interactions and
marketing practices) must be consistent with high ethical standards and
information should be designed to help healthcare providers to provide the best
care to patients. Information provided must be objective, truthful and in good
taste. It must also conform to all relevant laws and regulations. Claims for
therapeutic indications and conditions of use must be based on valid scientific
evidence and must include clear statements with respect to side effects,
contra-indications and precautions.
The same high standards of ethical behavior should
apply to the promotion of pharmaceutical products in all countries, regardless
of the level of development of their economic and health care systems.
These principles are embodied in the IFPMA Code
Practice, first adopted as the foundation of a global approach self-regulation
by the pharmaceutical industry in 1981 and updated frequently since then.
Building on the experience of the 2006 Code and discussions with key
stakeholders, the scope of the 2012 revision of the IFPMA Code has expanded
beyond marketing practices to cover interactions with healthcare professionals,
medical institutions and patient organizations. The IFPMA continues to support
self-regulation as the most appropriate mechanism for ensuring ethical
marketing and promotion of medicines by pharmaceutical companies it represents.
The
International Federation of Pharmaceutical Manufacturers and Associations
(IFPMA)
member companies engage in medical and
biopharmaceutical research in order to benefit
patients and support high-quality patient care.
Pharmaceutical companies, represented by
IFPMA, promote, sell and distribute their products
in an ethical manner and in accordance
with all the rules and regulations for medicines and
healthcare.
The following Guiding Principles set out basic
standards to inform the 2012 IFPMA Code of
Practice which applies to the conduct of IFPMA
Member Companies and their agents. This
helps ensure that their interactions with
stakeholders are appropriate.
1 The healthcare and well-being of patients are the
first priority for pharmaceutical
companies.
2 Pharmaceutical companies will conform to high
standards of quality, safety and efficacy
as determined by regulatory authorities.
3 Pharmaceutical companies’ interactions with
stakeholders must at all times be ethical,
appropriate and professional. Nothing should be
offered or provided by a company in a
manner or on conditions that would have an
inappropriate influence.
4 Pharmaceutical companies are responsible for
providing accurate, balanced, and
scientifically valid data on products.
5 Promotion must be ethical, accurate, balanced and
must not be misleading.
Information in promotional materials must support
proper assessment of the risks and
benefits of the product and its appropriate use.
6 Pharmaceutical companies will respect the privacy
and personal information of
patients.
7 All clinical trials and scientific research
sponsored or supported by companies will be
conducted with the intent to develop knowledge that
will benefit patients and advance
science and medicine. Pharmaceutical companies are
committed to the transparency of
industry sponsored clinical trials in patients.
8 Pharmaceutical companies should adhere to both the
spirit and the letter of applicable
industry codes. To achieve this, pharmaceutical
companies will ensure that all
relevant personnel are appropriately trained.
(ref: http://www.ifpma.org/fileadmin/content/Publication/IFPMA_Code_of_Practice_2012.pdf)