products are regulated in essentially every country of the world
are applicable to both the investigation and marketing of compounds.
Regulatory affairs professionals play pivotal roles in the
development, approval and surveillance of safe and effective health products
worldwide, ensuring compliance with applicable laws and regulations. Regulatory
affairs professionals are key, but perhaps overlooked, players in drug development.
They are the primary communications link between the company and agencies such
as FDA, and they are responsible for keeping up with the increasing scope and
complexity of regulations both here and abroad.
In the pharmaceutical industry, regulatory affairs
professionals have expertise in the legal and regulatory environments, as well
as in clinical research protocols. They are the primary interpreters of the
laws and regulations for other members of the company's R&D, manufacturing,
and compliance staff. Regulatory affairs professionals must have a thorough
understanding of the complex set of regulations within which FDA operates: 21 CFR (Code of Federal Regulations), Sections
1 through 1299. They also need to be familiar with regulations promulgated by a
whole range of agencies: the Environmental Protection Agency, Federal Trade
Commission, Occupational Safety & Health Administration, and Drug
Regulatory Affairs Defined
is a specialized profession within the pharmaceutical/biotechnology sector.
oversees company compliance with regulations and laws pertaining to the
manufacture, marketing and development of regulated products.
acts as point of contact between the company, its products and regulatory
interacts with worldwide, federal, state, and local regulatory agencies (e.g.,
FDA (US), EMEA (EU), BfARM (Germany), TPD (Canada), etc) to assure…
and medical products are conducted in compliance with all applicable rules
for marketing, manufacturing, and ongoing compliance of pharmaceutical/biotech
products is among the most regulated activities of any industry
complex systems of interrelated rules that govern a broad range of activities
These rules are
continuously undergoing amendment and supplementation
Their main function
is to assure that these products are safe (do no harm) and effective (do some good)
provide insight/guidance into this development through agency wisdom collected
in guidance, previous experience, market precedence, etc.
Compliance with Regulator expectations
therefore equates with development success. Patient Protection is of greatest
Regulatory Affairs Duties &
Advises and assists
the Commissioner and other key officials on regulations and compliance-oriented
matters that have an impact on Policy development and execution, and long-range
interprets, and evaluates the Agency's overall compliance efforts; as
necessary, establishes compliance policy or recommends policy to the
within the Agency of the need for prompt and positive action to assure
compliance by regulated industries; works to assure an effective and uniform
balance between voluntary and regulatory compliance and Agency responsiveness
to consumer needs.
coordinates all proposed legal actions to ascertain compliance with regulatory
policy and enforcement objectives.
Executes direct line authority over all Agency
field operations, develops, issues, approves, or clears proposals and
instructions affecting field activities; serves as the central point within the
Agency through which Headquarters offices obtain field support services.
and counsel to Regional Food and Drug Directors in the implementation of
policies and operational guidelines
that form the framework for management of Agency field-activities.
recommends to the Commissioner policy, programs, and plans for activities
between the Agency and State and local agencies; administers the Agency's
overall Federal-State program and policy, coordinates the program aspects of
Agency contracts with State and local counterpart agencies.
overall management and capabilities of the Agency's field organization;
initiates action to improve the management of field activities and coordinates
the formulation and management of career development plans.
coordinates the Agency's emergency preparedness and civil defense programs.
Operates the Federal
Medical Products Quality Assurance Program for the Agency
RAPS Code of Ethics for Regulatory Affairs
a living document that embodies the principles of professionalism and ethics to
which regulatory professionals aspire and hold inviolable.
Have a primary duty to
ensure our employer’s Activities are conducted in compliance with the laws and
regulations of the authorities under which we operate, consistent with
advancing, preserving and protecting public health.
Be competent to perform
the services we have been hired or retained to perform. As
regulatoryprofessionals we must commit ourselves to continual learning while
being able to acknowledge areas that are outside of our expertise.
Act in an objective
manner. As regulatory professionals we
must base decisions on factual information. We must not be unduly influenced by
competing or conflicting interests.
Have integrity. As
regulatory professionals we must be principled and consistent in applying our views.
We must live up to our commitments, and be trust worthy and scrupulous at all
Be honest in all dealings
with our employers and others with whom we interact. As regulatory professionals
we must ensure that information and communications, whether oral or written,
are accurate and complete. We acknowledge that personal and institutional
credibility are crucial to our success.
Have the courage to make
difficult decisions and present all relevant information to our organizations
to promote wise decisions. As regulatory professionals we must be able to withstand
challenges to our views, while at the same time be
accountable for our
Be fair in our dealings
with all parties. As regulatory professionals we must apply legal and regulatory
standards equitably. We must be just in considering the interests of all
parties in decision processes.
Be respectful of others,
whether it is our peers, subordinates or external parties with whom we interact.
We must treat all individuals with dignity and courtesy.
Our role as regulatory professionals
is defined by our duty to advise individuals and organizations regarding the
appropriate regulatory context for actions they may want to take.
Our roles are further
defined by our obligations as employees of companies that make important
medical products for patients, as members of teams that conduct nonclinical and
clinical studies, as regulators, and as members of our profession.
Have a primary duty to the
unbiased dissemination and interpretation of relevant governmental regulations,
industry standards and good practice guidelines.
Have a duty to our
employers to ensure products are safe and beneficial to patients,
While maintaining the
long-term interests of our employers.
Have a duty to those who
participate in clinical studies and who use regulated products to ensure that,
to the extent possible, the benefits justify the risks.
Have a duty to provide
physicians and other healthcare professionals with accurate and complete
information about the safety and Effectiveness of products.
Have a duty to our peers
to maintain the long-term integrity of our profession and to strive to deserve the
public’s confidence and respect.
Competence means that a
regulatory professional has the knowledge, abilities and skills necessary to effectively
identify, analyze and solve or recommend solutions to regulatory challenges.
professionals lend credibility to the profession by demonstrating they have the
knowledge, experience, dedication and flexibility to adapt to the ever-changing
realm of the regulatory profession.
The diversity of
individuals and organizational contexts within the regulatory profession
necessitates Commitment to a standard level of knowledge. This standard may be
achieved through a variety of means: Education, work experience, and professional
training and certifications.
Just as the regulatory
profession continues to evolve, maintaining competence within the field is a
continual learning process.
Seek to remain informed
and knowledgeable about current and future trends.
Avoid claims of competence
in any area in which they do not have a thorough understanding .
Encourage and support
opportunities for professional growth and development among peers and
subordinates so that all who work in the field can gain and demonstrate
competence in the profession.
Objectivity is treating or dealing with facts
without distortion by personal feelings or biases.
Regulatory professionals must be objective.
Although the regulatory professional must evaluate information from several
points of view, he/she must rely on a basic understanding of facts.
The interests of a number of parties may be affectedly
decisions made by regulatory professionals. These include the company,
regulators, healthcare professionals, patients
and shareholders, all of whose interests may be served differently and, in some
cases, in a contrary fashion. Regulatory professionals need to be cognizant of these
interests without letting them unduly influence their final actions.
Respond carefully to an opinion issue, recognizing
that there is rarely a single right or wrong answer Opinions can often take on
a partisan perspective. Caution must prevail and guide the professional to offer
an unbiased expression of facts.
Present all reasonable regulatory options and associated
risks when developing regulatory strategies.
Clearly differentiate among regulatory
requirements, internal requirements and personal preferences.
Disclose new information appropriately with the
Integrity is a commitment to a set of values. Individuals
with integrity are principled, scrupulous and trustworthy. Having integrity
suggests that one s “whole,” that one’s beliefs, words and actions are congruent
Regulatory professionals with integrity will
not compromise their values or trustworthiness for personal gain or
Live up to commitments.
credit for the work of others.
Maintain the confidentiality of information,
and never disclose information concerning the business or technical affairs of
employers or clients without their consent.
Seek advice from another individual or group
whose opinion they respect when uncertain.
When asked to compromise integrity for the sake
of one party over another, reconsider their obligations and the long-term
consequences of their actions.
Avoid being placed in situations that put their
integrity at risk.
Hold strong to beliefs, recognizing that what they
believe may be the best course of action may not be in the short-term interest
of their employer.
Never accept compensation that is not earned.
Avoid conflicts of interest relating to
employers or clients, or make them known when they are Unavoidable.
Honesty is understood as truthfulness, candor
and sincerity. It requires a person to act in ways free from deceit or deception,
including dishonesty by omission—failing to say something. Honesty requires one
to be candid and forthcoming, not simply to refrain from false statements.
Regulatory professionals, in fulfilling their
duty to patients, to their employer and to the profession, must exhibit honesty
in all of their activities. Honesty builds trust, essential to fostering
effective working relationships among regulatory authorities, the regulated
industry, individual corporations and individual regulatory professionals.
Ensure any information provided to subjects, patients,
healthcare providers, employers, regulatory authorities and consumers is
accurate and complete.
Ensure there have not been significant
omissions of information or false impressions implied.
Resist pressures to relax standards of honesty;
for example, to achieve expediency.
Ensure that submissions represent a complete profile
of the product under review.
Courage is the act of choosing what one
believes to be the right thing even when doing so is difficult.
Regulatory professionals must have the courage to
evaluate, conclude, and provide consistent and accurate regulatory advice. They
must have the courage to demand access to information that is required to do
their job, and they must do their job as completely as possible, including advising
stakeholders of potential risks. Regulatory professionals must have the courage
to give bad news when necessary and to accept the consequences of their
There will be situations where regulatory
advice needs to be retracted or corrected. The regulatory professional must
have the courage to bring forth the error and accept accountability, where
Review and reiterate their advice and strategy
when necessary or when challenged, and change it when appropriate.
Ask for help when needed.
Encourage an open exchange of views that challenge
Admit mistakes and take appropriate measures to
promptly correct them.
Deliver bad news quickly to management.
Provide information about risks and
consequences if regulatory advice is overruled or ignored.
Fairness means that all persons are being
treated equitably. In particular, it includes the principle of treating all
persons equally in accordance with the law and holding all those with common
responsibilities to a common standard.
Regulatory professionals must consider the
rights and needs of all parties affected by outcomes to which they contribute.
This includes the wise consideration of laws, science and appropriate societal
Respect the letter and spirit of governmental
laws and regulations.
the appropriate legal and regulatory standards to all cases, taking into
account cultural and regional differences and local requirements.
Present the facts and analysis of scientific information
using sound statistical interpretation that
strives to minimize bias even while giving results that may contain some
element of uncertainty.
Strive to ensure that the interests of all parties,
public and private, are appropriately considered in decision processes.
Respect is the regard for or appreciation of
the worth or value of someone or something.
First and foremost, regulatory professionals
will respect the role of their colleagues. As regulatory professionals we must
also be prepared to recognize and acknowledge the worth of all parties. This
recognition demonstrates the belief that everyone has value.
Listen to what others have to say in a fair and
from embarrassing, ridiculing or hurting others in their actions or omission of
Treat all parties, regardless of level or
position, with dignity, civility and courtesy.
Accept that personal differences will occur,
but work diligently toward finding a position that accommodates those
Create a positive environment that encourages
and promotes respect.
Share what they know in a non-intimidating way and
are tolerant of those who do not initially understand.
Avoid conflict where possible. If not possible,
find creative ways to resolve conflict in an effort to preserve a positive
patient and forgiving when others make mistakes and work to prevent the
mistakes from recurring rather than assigning blame.