this ppt is about the regulatory process of drug approval in different countries like USA, Europe, and Japan by the authority of FDA, EMA & PMDA.

1. Comparative Study of Drug Approval Process in
USA, EUROPE & JAPAN
Prepared by : Sandeep bansal
M.Pharmacy (DRA)

2. Contents
Drug approval process in United States.
Process of approval IND & NDA.
Drug approval process in Europe.
Europe approval procedures.
Drug approval procedure in Japan.
Selected References.

3. Drug Approval Process in United States
• The United States has perhaps the world’s most stringent
standards for approving new drugs.
• Drug approval standards in the United States are considered
by many to be the most demanding in the world.
• The Food and Drug Administration (FDA) is responsible for
protecting and promoting public health.
• Like general drug approval process, FDA's new drug approval
process is also accomplished in two phases: clinical trials (CT)
and New Drug Application (NDA) approval.
• FDA approval process begins only after submission of
Investigational New Drug (IND) application.

5. Process of approval IND & NDA
• Investigational New Drug (IND) Application :
• It’s an application filed to the FDA to start clinical trials in
humans if the drug was found to be safe from the reports of
Preclinical trials.
• The IND application should provide high excellence
preclinical data to justify the testing of the drug in humans.
• Almost 85% of drugs are subjected to clinical trials, for which
IND applications are filed.
• An institution, called a Sponsor, is responsible for submitting
the IND application.

7. Continued…
• New drug application (NDA) :
• A New Drug Application (NDA) can be filed only when the drug
successfully passes all three phases of clinical trials and comprises
all animal and human data, data analyses, pharmacokinetics of drug
and its manufacturing and anticipated labeling.
• The preclinical, clinical reports and risk-benefit analysis are studied
at the Centre for Drug Evaluation.
• If clinical studies confirm that a new drug is comparatively safe and
effective, and will not pose irrational risks to patients, the
manufacturer files a New Drug Application (NDA), the actual
request to manufacture and can market the drug in the United States.
• Generally, approval of an NDA is granted within two years,
however, this process can be finalized from two months to several
years.

9. Drug Approval Process in Europe
• Similar to the US requirements, there are two regulatory
steps to go through before a drug is approved to be
marketed in the European Union.
• These two steps are clinical trial application and
marketing authorization application.
• There are 28 member states in the European Union (as of
July, 2013);.
• Clinical Trial Applications are approved at the member
state level, whereas marketing authorization applications
are approved at both the member state and centralized
levels.

10. Europe approval procedures
There are four procedures in Europe are :
1. Centralized procedure :The centralized procedure is one
which allows applicants to obtain a marketing authorization
that is valid throughout the EU. EMA opinion issued within
210 days, and submitted to European Commission for final
approval.
2. Mutual Recognition Procedure : The Mutual Recognition
procedure allows applicants to obtain a marketing
authorization in the Concerned member states (CMS)
other than the Reference member state (RMS), where
the drug is previously approved.

11. Continued….
3. Nationalized procedure : The Nationalized
procedure is one which allows applicants to
obtain a marketing authorization in one member
state only. Timeline for this procedure is 210
Days.
4. Decentralized procedure: Using this procedure,
companies may apply for authorization
simultaneously in more than one EU country for
products that have not yet been authorized in any
EU country and essentially do not fall within the
centralized procedure’s essential drugs list.

12. Drug approval procedure in Japan
• The entire process of approval review from review-
related inspections and clinical trial consultation to
review works is undertaken by the PMDA.
• application forms for approval to market drugs are
usually submitted to the PMDA.
• When application forms for new drugs are received by
the PMDA, a compliance review of the application data
(certification from source data), GCP on-site inspection,
and detailed review are undertaken by review teams of
the PMDA and the team prepares a review report.

13. Continued…
• The drug approval process in Japan includes a sequence of
non-clinical studies, clinical studies followed by approval
review, and post-marketing surveillance.
• The standard clinical studies include Phase 1, Phase 2, and
Phase 3 studies. Along with this traditional drug approval
route, there are bridging studies for drug approval.
• Once a drug successfully completes all three phases of clinical
trial, the manufacturer must file the New Drug Application (or
NDA) with the Pharmaceuticals and Medical Devices Agency
(or PMDA).
• After review and evaluation, the PMDA provides a
recommendation and forwards the application for approval to
the Ministry of Health, Labour and Welfare (or MHLW).

16. Selected References
1. Mulaje SS. Procedure for drug approval in different
countries: a review. Journal of Drug Delivery and
Therapeutics. 2013 Mar 17;3(2).cited 4 April 2019 .
2. Chakraborty K, Yadav K. Drug approval process in US,
Europe and India and its regulatory requirements: A Review.
Cited 4 April 2019
3. Vishal P, Rahulgiri G, Pratik M, Badjatya JK. A review on
drug approval process for US, Europe and India.
International Journal of Drug Regulatory Affairs. 2014 Mar
1;2(1):1-1.cited 4 April 2019
4. What's the Drug Approval Process in Japan? - Market Realist
[Internet]. Market Realist. 2019 [cited 4 April 2019].
Available from
https://articles.marketrealist.com/2016/04/whats-drug-
approval-process-japan/