Introduction R&A

Regulatory Affairs
REGULATORY AFFAIRS
• Regulatory affairs is a comparatively new profession
which developed from the desire of governments to
protect public health by controlling the safety and
efficacy of products in areas including
pharmaceuticals,
veterinary medicines,
medical devices,
pesticides,
agrochemicals,
cosmetics and complementary medicines.
REGULATORY AFFAIRS :
• Regulatory affairs (RA), is a profession within regulated
industries. Regulatory affairs also has a very specific
meaning within the healthcare industries.
• The companies responsible for the discovery, testing,

manufacture and marketing of these products also want
to ensure that they supply products that are safe and
make a worthwhile contribution to public health and
welfare.
Regulatory Affairs ensure the Quality and Safety

Regulatory Affairs Professionals Responsibility
• The regulatory professional’s job is to keep track of the ever-

changing legislation in all the regions in which the company
wishes to distribute its products.
• They also advise on the legal and scientific restraints and

requirements, and collect, collate and evaluate the scientific
data their research and development colleagues are generating
Regulatory Affairs manage the Scientific Data

Regulatory Affairs Professionals Responsibility
• They are responsible for the presentation of registration documents
to regulatory agencies, and carry out all the subsequent negotiations
necessary to obtain and maintain marketing authorization for the
products concerned. Registration Documents
• They give strategic and technical advice at the highest level in their
companies, right from the beginning of the development of a product,
making an important contribution both commercially and scientifically
to the success of a development program and the company as a
whole. legal adviser
• Healthcare Regulatory Affairs (RA) : The regulatory function in
healthcare industries is vital in making safe and effective healthcare
products available worldwide. Individuals who ensure regulatory
compliance and prepare submissions, as well as those whose main job
function is clinical affairs or quality assurance are all considered
regulatory professionals.
• Regulatory professionals are employed in industry, government and
academia and are involved with a wide range of products, including:
 Pharmaceuticals
 medical devices
 in vitro diagnostics
 biologics and biotechnology
 nutritional products

Regulatory Landscape and Product development (R&D) :
• The regulatory strategy and the development plan are evolving documents.
They should be reviewed and updated on a regular basis during the product
development process.
• Step 1:
Properly classify your healthcare product (i.e., as a drug, a biologic, a
medical device or a combination product) so that you know which
regulatory path to take. If in doubt, contact the appropriate regulatory body
to confirm the product type and how your product is regulated.
• Step 2
Identify the claim of your healthcare product so that you know what types
of studies to conduct to support the claim and your product label. For
instance, changing your claim.
May change the medical device classification which can lead to different
regulatory oversight
• Step 3:
Determine your healthcare market. This will guide you to the
requirements that are specific to each jurisdiction. It is important to
identify jurisdiction-specific requirements upfront.
so that they can be included early in the product development plan.
• Step 4:
Develop your regulatory strategy by identifying the specific regulatory
requirements as well as the possible pathway(s) to take.
A thorough understanding of these requirements will guide the
development of your regulatory strategy.
• Step 5:
Establish a healthcare product development plan.
so that the product requirements can be translated into action i.e., who does
what and by when and for how much. Such plan should be established
collaboratively with input from different functional groups. It should include key
milestones, critical paths and periodic reviews for “go and no-go” decisions and
be updated periodically.
• Step 6:
Execute the product development plan It is subject-matter experts who possess
knowledge of the investigational product who must carry out (and be
responsible for) the corresponding manufacturing, quality, regulatory, non-
clinical and clinical programs, as well as any coordination with third parties
• Step 7:
Execute the clinical plan
If a clinical program is required in support of the licensing application, these studies
should be conducted according to good clinical practices (GCP) and country-specific
requirements, such as ethics approvals and/or necessary regulatory approvals or
conducting the clinical trial(s). Often, it helps to have a pre-submission meeting with
the regulatory agency prior to submitting a clinical trial application in order to
address specific
• Step 8:
Collect your data for regulatory submission .Once the data from the product design
and the manufacturing, quality, non-clinical and clinical programs are available, these
data and reports should be collected for inclusion in the regulatory submission.
• Step 9:
Collate your regulatory submission according to applicable regulatory
requirements specific to your type of submission. Ensure the completeness of
the submission and anticipate the resources needed to address questions
from the agency during the submission review. For an innovative healthcare
product, it is often recommended to have a pre-submission meeting with your
agency prior to submitting the licensing application.
• Step 10:
Ensure post-marketing compliance.
Make sure to fulfill all necessary post-marketing obligations.

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Regulatory Affairs

• The companies responsible for the discovery, testing,

Regulatory Affairs ensure the Quality and Safety

• The regulatory professional’s job is to keep track of the ever-

• They also advise on the legal and scientific restraints and

Regulatory Affairs manage the Scientific Data

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