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Assignment of Drug Regulatory

The document discusses the similarities and differences in the approval procedures for new drug applications in the USA and EU, highlighting the roles of the FDA and EMA, regulatory pathways, and timelines. It also outlines the risks associated with drug development, including clinical, regulatory, financial, and intellectual property risks, as well as opportunities such as technological innovations, global market expansion, and collaboration. Overall, it emphasizes the importance of thorough regulatory processes to ensure drug safety and efficacy while navigating the complexities of drug development.

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10 views6 pages

Assignment of Drug Regulatory

The document discusses the similarities and differences in the approval procedures for new drug applications in the USA and EU, highlighting the roles of the FDA and EMA, regulatory pathways, and timelines. It also outlines the risks associated with drug development, including clinical, regulatory, financial, and intellectual property risks, as well as opportunities such as technological innovations, global market expansion, and collaboration. Overall, it emphasizes the importance of thorough regulatory processes to ensure drug safety and efficacy while navigating the complexities of drug development.

Uploaded by

Aryan 009
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
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GURU GOBIND SINGH COLLEGE OF PHARMACY

Topic:- Similarities and differences in approval procedure for


new drug applications in USA and EU along with risks and
opportunities in development of new drug

Submitted to:- submitted by :-


DR. Anjali Sharma Abhishek(601)
Introduction:-
A New Drug Application (NDA) is a formal request submitted
to regulatory authorities, like the FDA, to approve a new drug
for sale and use. It includes data on the drug's safety,
effectiveness, and manufacturing process, based on clinical
trials and other studies. The NDA is essential for ensuring
that a drug is safe and works as intended before it can be
prescribed to patients
Similarities:
Preclinical and Clinical Trials: Both the USA (via the FDA) and
Europe (via the EMA) require comprehensive preclinical and
clinical trial data to demonstrate a drug’s safety, efficacy,
and quality before approval. Both regions emphasize Phase
I, II, and III clinical trials.
Regulatory Review: Both the FDA and the EMA assess the
data from clinical trials, including pharmacokinetics,
pharmacodynamics, and potential side effects, as part of
the approval process. These regulatory bodies review the
benefits and risks of the drug to determine whether it should
be approved for market use.
Good Manufacturing Practices (GMP): Both the FDA and
EMA require compliance with GMP standards for the
manufacturing of pharmaceutical products to ensure quality
control throughout production.
Post-Marketing Surveillance: After drug approval, both
regions require ongoing monitoring for adverse effects
through mechanisms like the FDA’s REMS (Risk Evaluation
and Mitigation Strategies) and the EMA’s pharmacovigilance
programs.
Differences:
Regulatory Bodies:
In the USA, the Food and Drug Administration (FDA) is
responsible for drug approval.
In Europe, the European Medicines Agency (EMA) oversees
drug approval, but the process involves national regulatory
agencies in EU member states.
Approval Pathways:
USA: The FDA offers specific expedited pathways such as
Breakthrough Therapy Designation, Priority Review, and
Accelerated Approval to fast-track drugs that address unmet
medical needs.
Europe: The EMA provides similar mechanisms like the
Conditional Marketing Authorization, Accelerated
Assessment, and Orphan Drug Designation, but the overall
approval process might be slightly longer due to the multi-
country involvement.
Centralized vs. National Procedures:
In Europe, the EMA can grant Centralized Marketing
Authorization, which is valid across all EU countries.
However, certain drugs may go through national procedures
via local regulatory authorities in individual countries.
In the USA, the FDA’s approval is applicable nationwide
without the need for separate state approvals.
Timeline for Approval:
The approval timeline can vary: In the USA, the FDA’s review
typically takes about 10 months for standard applications
and 6 months for priority reviews.
In Europe, the EMA’s review process generally takes around
210 days, although it can vary depending on the complexity
of the application and the presence of any additional
requirements.
Market Exclusivity:
USA: The FDA offers market exclusivity periods such as New
Chemical Entity exclusivity, Orphan Drug exclusivity, or
Paediatric exclusivity, which may provide advantages like
extended protection for specific periods.
Europe: The EMA offers similar exclusivity periods, including
data exclusivity (typically 8 years) and market exclusivity (10
years), but the details of these protections may vary slightly.
Risk and drug development:-
1. Clinical development risk
• Failure to demonstrate safety or efficacy during trial.
• Challenges in recruiting a diverse patient population
2. Regulatory risk
• Delay or rejection due to incomplete data
• Varied regulatory requirements between region can
complicate submission.
3. Financial Risks
• High cost of development, averaging over $2billion per
drug.
• Risk of market rejection due to high pricing or lack of
payers support.
4. Intellectual property risks
• Loss of patent exclusivity before product launch.
• Threat of generic competition in certain markets.

Opportunities in drug development:-


A. Technological innovations
• Advances in AI, genomics and drug delivery system
accelerate development.
• Precision medicine allows for targeted therapies.
B. Global market
• Leveraging dual approval (FDA and EMA) enhance
global reach.
• Emerging markets offer additional growth opportunities.
C.Collaboration and partnership
• Joint venture with academic institutions or biotech
firms reduce development costs.
• Licensing deals enable access to innovative
technologies.

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