SFDA-2007

Bioequivalence Studies of Generic

Pharmaceutical Products
Workshop-Day II
Introduction and workshop Objectives
By:
Saleh A. Al-Suwayeh, M.Sc., Ph.D.
Associate Professor of Pharmaceutics,
College of Pharmacy, King Saud University &
Chairman of the Technical Registration Committee at the
Saudi MOH
SFDA-2007
General Outline
I. Introduction and Background:
The transitional state between the Saudi
MOH and the Saudi FDA.
Bioequivalence studies as essential part of
the registration dossier.
SFDA future expectations.

II. Bioequivalence Workshop Objectives

III. Conclusions

SFDA-2007
I. Introduction and Background:
The transitional state between the Saudi MOH and the
Saudi FDA:

In the past 30 years, the Saudi MOH was
responsible for regulating pharm. products and
manufactures.
The Saudi FDA was Founded in 2003 based on
the Royal Decree # 1 dated 7/1/1424 AH.
Independent Regulatory Body Directly
Supervised by the Supreme Council of Ministers.
- Establishment Phase Extends over a 5 Year
Period.
One of its prime duties is to assume regulatory
responsibility of pharmaceutical products and
manufactures from MOH.


SFDA-2007
Bioequivalence Studies as Essential Part of the
Registration Dossier.

Table of Contents of the Dossier
Signed Registration Form
Composition and Methods of Analysis
Stability Studies
Certificate of Analysis of the Finished Product
Free Sale Certificate / CPP
Package Insert
Product Samples in Final Form
List of Countries where Product is Registered and
Marketed
Clinical Studies (efficacy, safety, toxicology,
pharmacologyetc.)
Bioavailability or Bioequivalence Studies
PMS Studies.


SFDA-2007
SFDA Future Expectations
1) To provide Written published Laws and Guidelines such
as:
Current GMP Guidelines
Stability Guidelines
Bioequivalence studies Guidelines
Rules of Co-manufacturing
Rules of Resourcing
Pricing Guidelines and other guidelines.

- Guidelines can provide information that enhance safety,
reliability and performance of services
- Guidelines provide reference criteria that a process or service must
meet
- The culmination of mandatory guidelines is intended to be improved
public health.
2) To reduce Shortage of Staff and Reduce Turnover Rate
of Personnel

3)To provide proper training of personnel via symposia
and workshops e.g., this current bioequivalence workshop.
SFDA-2007
II. Bioequivalence Workshop Objectives

, many theoretical basis and this morning 1 So far in day
were discussed to lay down foundation for todays
practical experience. These theoretical basis essentially
included:
An overview of the SFDA Bioequivalence guidelines.
Bioanalytical methodology and validation
Statistical analysis and acceptance criteria
More emphasis on special consideration for some drugs
( long t1/2 drugs..etc.)
A special topic on the regulatory guidelines for
biosimilars.
Inspection of bioequivalence centers and analytical
laboratories.
SFDA-2007
II. Bioequivalence Workshop Objectives

Objctives of Day 2:
1) To familiarize participants with other important
theoretical basis as preparation for the practical
experience.
These theoretical basis will essentially include
Contents of Bioequivalence report.
Evaluation forms and check lists
How to evaluate Bioequivalence report

2) To provide participants with hands-on practical
experience of bioequivalence report dealing with
different issues of bioequivalency such as:
Bioanalytical section of Bioequivalence study
Statistical report of Bioequivalence study
PK parameters essential in a Bioequivalence study
A good and a poor example of Bioequivalence studies
will be presented.
SFDA-2007
III. Conclusion
With the newly founded independent Saudi FDA
and with updated published guidelines and well
trained personnel, we are very optimistic that the
process of registration will be more efficient in
terms of time and effort leading consequently to a
positive impact on the health of the public.
GOOD LUCK