SFDA-2007 الهيئة العامة للغذاء والدواء 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 الهيئة العامة للغذاء والدواء 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 الهيئة العامة للغذاء والدواء 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 الهيئة العامة للغذاء والدواء 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.

SFDA-2007 الهيئة العامة للغذاء والدواء 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 الهيئة العامة للغذاء والدواء 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.

SFDA-2007 الهيئة العامة للغذاء والدواء 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 الهيئة العامة للغذاء والدواء 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 ”