REGULATORY SCIENCE IN PHARMACEUTICAL MEDICINE

By : Affaf Attiq
Submitted to:
Doctor Faisal badshah
Subject :Regulatory science
 “REGULATORY SCIENCE IN
PHARMACEUTICAL MEDICINE “

The regulatory sciences encompass a wide scope of activities,

ranging from laboratory work to support drug product quality
through pharmacokinetics and pharmacodynamics to post-
marketing surveillance.
Pharmaceutical regulatory science definition
Pharmaceutical scientists play a vital role in the development of new
medicines, from discovery chemistry, through to formulation
development, manufacturing and clinical testing, and post marketing
Pharmacovigilance.
Pharmaceutical regulation should be established based on the most
advanced scientific expertise at all times. In order to evaluate
products that use cutting-edge technology such as induced
pluripotent stem cells and information and communication
technology adequately, since fiscal year 2012 the Science Committee
has been established as a platform to exchange opinions among
members from top-ranking domestic and international academia and
to enhance personnel exchanges through the Initiative to Facilitate
Development of Innovative Drugs. In addition, the Regulatory Science
Center will be established in 2018 to increase the integrity of our
services for product reviews and safety measures. In particular,
requiring electronic data submissions for clinical trial applications
followed by an advanced approach to analysis should not only

2
enhance the quality of reviews of individual products but should also
support the development of pharmaceuticals and medical devices by
providing pharmaceutical affairs consultations on research and
development strategies with various guidelines based on new insights
resulting from product-bridging data analysis. Moreover, a database
including electronic health records with comprehensive medical
information collected mainly from 10 cooperating medical institutions
will be developed with the aim of developing safety measures in a
more timely manner using methods of pharmacoepidemiological
analysis.

Role of regulatory science in medicine department

THE ROLE OF THE REGULATORY AFFAIRS DEPARTMENT

THE REGULATORY AFFAIRS (RA) DEPARTMENT OF A

PHARMACEUTICAL COMPANY IS RESPONSIBLE FOR OBTAINING
APPROVAL FOR NEW PHARMACEUTICAL PRODUCTS AND
ENSURING THAT APPROVAL IS MAINTAINED FOR AS LONG AS THE
COMPANY WANTS TO KEEP THE PRODUCT ON THE MARKET.

3
4