8
-2007 SFDA اء والدواء د غ ل ل غامة ل ا ة ئ هي ل اBioequivalence 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 الهيئة العامة للغذاء والدواء Bioequivalence Studies of Generic Pharmaceutical Products Workshop-Day II Introduction and workshop Objectives By:

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Page 1: SFDA-2007 الهيئة العامة للغذاء والدواء Bioequivalence Studies of Generic Pharmaceutical Products Workshop-Day II Introduction and workshop Objectives By:

SFDA-2007 والدواء للغذاء العامة الهيئة

Bioequivalence Studies of Generic Pharmaceutical Products

Workshop-Day II

Introduction and workshop ObjectivesBy:

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

Page 2: SFDA-2007 الهيئة العامة للغذاء والدواء Bioequivalence Studies of Generic Pharmaceutical Products Workshop-Day II Introduction and workshop Objectives By:

SFDA-2007 والدواء للغذاء العامة الهيئة

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

Page 3: SFDA-2007 الهيئة العامة للغذاء والدواء Bioequivalence Studies of Generic Pharmaceutical Products Workshop-Day II Introduction and workshop Objectives By:

SFDA-2007 والدواء للغذاء العامة الهيئة

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.

Page 4: SFDA-2007 الهيئة العامة للغذاء والدواء Bioequivalence Studies of Generic Pharmaceutical Products Workshop-Day II Introduction and workshop Objectives By:

SFDA-2007 والدواء للغذاء العامة الهيئة

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,

pharmacology…etc.) Bioavailability or Bioequivalence Studies PMS Studies.

Page 5: SFDA-2007 الهيئة العامة للغذاء والدواء Bioequivalence Studies of Generic Pharmaceutical Products Workshop-Day II Introduction and workshop Objectives By:

SFDA-2007 والدواء للغذاء العامة الهيئة

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.

Page 6: SFDA-2007 الهيئة العامة للغذاء والدواء Bioequivalence Studies of Generic Pharmaceutical Products Workshop-Day II Introduction and workshop Objectives By:

SFDA-2007 والدواء للغذاء العامة الهيئة

II. Bioequivalence Workshop Objectives

So far in day 1 and this morning, many theoretical basis were discussed to lay down foundation for today’s 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.

Page 7: SFDA-2007 الهيئة العامة للغذاء والدواء Bioequivalence Studies of Generic Pharmaceutical Products Workshop-Day II Introduction and workshop Objectives By:

SFDA-2007 والدواء للغذاء العامة الهيئة

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.

Page 8: SFDA-2007 الهيئة العامة للغذاء والدواء Bioequivalence Studies of Generic Pharmaceutical Products Workshop-Day II Introduction and workshop Objectives By:

SFDA-2007 والدواء للغذاء العامة الهيئة

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”